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FDA Recalls and Warnings: Foreign Substance Found in Millions of Steroid Eye Drops, Seizure Drug Mix-Up & More

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Get the latest FDA updates on medication recalls, manufacturing violations, and quality concerns that could affect your prescriptions

Katie Rowley

July 1, 2026

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Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting recalls for Aripiprazole, Alyacen 7/7/7, Chlorthalidone, Corlanor, Duloxetine Delayed Release, Fenofibrate, Focalin XR, Lacosamide, Methylergonovine Maleate, Nicotine Transdermal System Patch, PRED MILD, Prednisolone Acetate, and Sensipar.

All drug recalls in this installment are nationwide “Class II” recalls, except for Nicotine Transdermal System Patch and PRED MILD eye drops, which are “Class III recalls.” Consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates. For prescription drugs that don’t include a lot number on the packaging, consumers may check with their pharmacist to see whether a medication is affected by the recall.

How to Read This Report

The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or “not yet classified.”

While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.

Class I recalls are the most serious. In these situations, there is “reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.”
Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.
Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.

Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.

FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of FDA laws, including violations of “current good manufacturing practices for finished pharmaceuticals” or unapproved new drugs. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.

Drug Recalls

Aripiprazole Tablets (generic for Abilify)

Company: Ajanta Pharma USA Inc.
Manufacturing Location: India
Scope: 6,143 bottles (30-count) 30 mg tablets
Drug Purpose: Treats schizophrenia and bipolar disorder
Recall Reason: Product mix-up; a bottle containing Voriconazole Tablets 50 mg was labeled and distributed as Aripiprazole Tablets 30 mg. Voriconazole is an antifungal treatment.
Recall Date: May 27, 2026
Link: FDA Enforcement Report

Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets

Company: Glenmark Pharmaceuticals Inc.
Manufacturing Location: Colvale-Bardez, Goa, India by Glenmark Pharmaceuticals Ltd.
Scope: Unspecified quantity of sets of 3 blister cards containing 28 tablets containing 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg of Norethindrone and Ethinyl Estradiol
Drug Purpose: Oral contraceptive to prevent pregnancy
Recall Reason: Failed impurities/degradation specifications; this could affect drug quality and shelf life.
Recall Date: 5/27/2026;
Link: FDA Enforcement Report

Chlorthalidone Tablets

Company: Rising Pharma Holdings, Inc.
Manufacturing Location: Ambernath (East), India by Inventia Healthcare Limited
Scope: 11,460 bottles (100-count and 1000-count) 25 mg tablets
Drug Purpose: Diuretic used to treat high blood pressure
Recall Reason: Failed dissolution specifications: the capsules may not dissolve properly, potentially reducing their effectiveness.
Recall Date: 6/5/2026
Link: FDA Enforcement Report

Corlanor (Ivabradine) Tablets

Company: Amgen Inc., Thousand Oaks, California
Manufacturing Location: Italy
Scope: 934,577 bottles (14-count and 60-count) 5 mg tablets
Drug Purpose: Treats patients with heart failure and reduces the risk of hospitalization for worsening heart failure in adults
Recall Reason: Presence of unspecified foreign substance in the tablets.
Recall Date: June 4, 2026
Essential Extras: Corlanor (Ivabradine) Tablets have been discontinued by Amgen. The tablets will still be available from multiple generic suppliers. This recall is part of the same Amgen recall involving Sensipar (Cinacalcet) Tablets.
Link: FDA Enforcement Report

Duloxetine Delayed-Release Capsules (generic for Cymbalta)

Company: Direct Rx, Dawsonville, Georgia
Manufacturing Location: Not specified
Scope: 263 bottles (30-count and 60-count) 30 mg capsules
Drug Purpose: Antidepressant
Recall Reason: Presence of nitrosamine impurities above the FDA-recommended limit. Nitrosamine impurities may increase the risk of cancer.
Recall Date: June 22, 2026
Link: FDA Enforcement Report

Fenofibrate Capsules

Company: Ajanta Pharma USA Inc.
Manufacturing Location: India by Ajanta Pharma Limited
Scope: 3,648 bottles (100-count) 200 mg capsules
Drug Purpose: A fibrate medication to help lower high triglycerides and increase levels of “good” (HDL) cholesterol
Recall Reason: CGMP (Current Good Manufacturing Practice) deviations; this could affect product quality.
Recall Date: May 28, 2026
Link: FDA Enforcement Report

Focalin XR (dexmethylphenidate HCl) Capsules

Company: Sandoz Inc.
Manufacturing Location: Gainesville, Georgia by Societal CDMO Gainesville, LLC
Scope: 7,803 bottles (30-count) 5 mg capsules
Drug Purpose: Treats ADHD (Attention-deficit/hyperactivity disorder)
Recall Reason: Labeling issue; incorrect or missing lot and/or expiration date.
Recall Date: June 1, 2026
Link: FDA Enforcement Report

Lacosamide Tablets (generic for Vimpat)

Company: Annora Pharma Pvt. Ltd.
Manufacturing Location: Sangareddy, Telangana, India for Camber Pharmaceuticals, Inc., Piscataway, New Jersey
Scope: 31,392 (60-count) bottles of 100 mg tablets
Drug Purpose: Seizure treatment
Recall Reason: Product mix-up: complaint of a Selexipag 1000 mcg tablet in a bottle of Lacosamide 100 mg. Selexipag treats pulmonary arterial hypertension.
Recall Date: June 4, 2026
Link: FDA Enforcement Repor t

Nicotine Transdermal System Patch, 14 mg

Company: Aveva Drug Delivery Systems
Manufacturing Location: Not specified; distributed by Rugby Laboratories, Indianapolis, Indiana
Scope: 59,808 patches 14 mg strength (4,272 individual 14-count cartons)
Drug Purpose: Nicotine replacement therapy used to help people stop smoking. The 14 mg strength is “Step 2” of a three-part quit-smoking system.
Recall Reason: Impurities (“Oxidative-related”) exceeded shelf-life limits during stability testing; this could affect drug’s effectiveness and shelf life.
Recall Date: May 14, 2026
Link: FDA Enforcement Report

Methylergonovine Maleate Tablets (generic for Methergine)

Company: Harvard Drug Group; Packaged and distributed by Major Pharmaceuticals, Indianapolis, Indiana
Manufacturing Location: Chantilly, Virginia by Granules Pharmaceuticals
Scope: 790 cartons (about 16,000 20-count blister packs) of 0.2 mg tablets
Drug Purpose: Prevents or reduces postpartum bleeding
Recall Reason: Subpotent; the amount of active ingredient was less than the allowable range. Recall Date: May 27, 2026
Link: Enforcement Report

PRED MILD (Prednisolone Acetate Ophthalmic Suspension)

Company: AbbVie Inc.; Allergen, Inc. (an AbbVie company)
Manufacturing Location: France
Scope: 2,736 bottles (0.12%, 10 mL)
Drug Purpose: Steroid eye drop used to treat eye inflammation
Recall Reason: Failed stability specifications; this could affect the drug’s effectiveness and shelf life.
Recall Date: May 18, 2026
Link: FDA Enforcement Report

Prednisolone Acetate Ophthalmic Suspension, USP, 1%

Company: Lupin Pharmaceuticals Inc.
Manufacturing Location: Pithampur, India by Lupin Limited
Scope: 2,530,182 bottles of 5 mL, 10 mL, and 15 mL prednisolone acetate ophthalmic suspension
Drug Purpose: Steroid eye drop used to treat eye inflammation
Recall Reason: Presence of foreign substance (Because this recall was just announced on July 1, 2026, there are no additional details listed at the time of publication).
Recall Date: June 4, 2026
Link: FDA Enforcement Report

Sensipar (Cinacalcet) Tablets

Company: Amgen Inc., Thousand Oaks, California
Manufacturing Location: Japan
Scope: 9,565 bottles (30-count) 30 mg tablets; unspecified number of bottles of 60 mg and 90 mg tablets
Drug Purpose: Treats hyperparathyroidism, a condition in which one or more of the parathyroid glands in the neck produce too much parathyroid hormone.
Recall Reason: CGMP (Current Good Manufacturing Practice) deviations, which could affect drug quality.
Recall Date: June 4, 2026
Essential Extras: Sensipar (Cinacalcet) Tablets have been discontinued by Amgen. The tablets will still be available from multiple generic suppliers. This recall is part of the same Amgen recall involving Corlanor (Ivabradine) tablets.
Link: FDA Enforcement Report

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Article HTML

<!-- wp:paragraph -->
<p>Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting recalls for Aripiprazole, Alyacen 7/7/7, Chlorthalidone, Corlanor, Duloxetine Delayed Release, Fenofibrate, Focalin XR, Lacosamide, Methylergonovine Maleate, Nicotine Transdermal System Patch, PRED MILD, Prednisolone Acetate, and Sensipar.</p>
<!-- /wp:paragraph --><!-- wp:paragraph -->
<p>All drug recalls in this installment are nationwide “Class II” recalls, except for Nicotine Transdermal System Patch and PRED MILD eye drops, which are “Class III recalls.” Consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates. For prescription drugs that don’t include a lot number on the packaging, consumers may check with their pharmacist to see whether a medication is affected by the recall. </p>
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<div class="wp-block-group"><!-- wp:heading -->
<h2 class="wp-block-heading">How to Read This Report</h2>
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<h3 class="wp-block-accordion-heading"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">Recalls (Enforcement Reports Database)</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></h3>
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<div role="region" class="wp-block-accordion-panel"><!-- wp:paragraph -->
<p>The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or "not yet classified."</p>
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<p>While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.</p>
<!-- /wp:paragraph --><!-- wp:list -->
<ul class="wp-block-list"><!-- wp:list-item -->
<li>Class I recalls are the most serious. In these situations, there is "reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death."</li>
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<li>Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.</li>
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<li>Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.</li>
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<h3 class="wp-block-accordion-heading"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">Warning Letters (Warning Letters Database)</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></h3>
<!-- /wp:accordion-heading --><!-- wp:accordion-panel -->
<div role="region" class="wp-block-accordion-panel"><!-- wp:paragraph -->
<p>Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.</p>
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<div role="group" class="wp-block-accordion"><!-- wp:accordion-item -->
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<h3 class="wp-block-accordion-heading"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">Drug Imports Alerts Database</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></h3>
<!-- /wp:accordion-heading --><!-- wp:accordion-panel -->
<div role="region" class="wp-block-accordion-panel"><!-- wp:paragraph -->
<p>FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211">FDA laws</a>, including violations of “current good manufacturing practices for finished pharmaceuticals” or <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-99">unapproved new drugs</a>. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.</p>
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<h2 class="wp-block-heading">Drug Recalls</h2>
<!-- /wp:heading --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Aripiprazole Tablets (generic for Abilify)</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Company</strong>: Ajanta Pharma USA Inc.<br><strong>Manufacturing Location</strong>: India<br><strong>Scope</strong>: 6,143 bottles (30-count) 30 mg tablets<br><strong>Drug Purpose</strong>: Treats schizophrenia and bipolar disorder<br><strong>Recall Reason</strong>: Product mix-up; a bottle containing Voriconazole Tablets 50 mg was labeled and distributed as Aripiprazole Tablets 30 mg. Voriconazole is an antifungal treatment.<br><strong>Recall Date</strong>: May 27, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99046">FDA Enforcement Report</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Company</strong>: Glenmark Pharmaceuticals Inc.<br><strong>Manufacturing Location</strong>: Colvale-Bardez, Goa, India by Glenmark Pharmaceuticals Ltd.<br><strong>Scope</strong>: Unspecified quantity of sets of 3 blister cards containing 28 tablets containing 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg of Norethindrone and Ethinyl Estradiol<br><strong>Drug Purpose</strong>: Oral contraceptive to prevent pregnancy<br><strong>Recall Reason</strong>: Failed impurities/degradation specifications; this could affect drug quality and shelf life.<br><strong>Recall Date</strong>: 5/27/2026;<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99101">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Chlorthalidone Tablets</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Company</strong>: Rising Pharma Holdings, Inc.<br><strong>Manufacturing Location</strong>: Ambernath (East), India by Inventia Healthcare Limited<br><strong>Scope</strong>: 11,460 bottles (100-count and 1000-count) 25 mg tablets<br><strong>Drug Purpose</strong>: Diuretic used to treat high blood pressure<br><strong>Recall Reason</strong>: Failed dissolution specifications: the capsules may not dissolve properly, potentially reducing their effectiveness.<br><strong>Recall Date</strong>: 6/5/2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99136">FDA Enforcement Report</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Corlanor (Ivabradine) Tablets</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Company</strong>: Amgen Inc., Thousand Oaks, California<br><strong>Manufacturing Location</strong>: Italy<br><strong>Scope</strong>: 934,577 bottles (14-count and 60-count) 5 mg tablets <br><strong>Drug Purpose</strong>: Treats patients with heart failure and reduces the risk of hospitalization for worsening heart failure in adults<br><strong>Recall Reason</strong>: Presence of unspecified foreign substance in the tablets.<br><strong>Recall Date</strong>: June 4, 2026<br><strong>Essential Extras</strong>: Corlanor (Ivabradine) Tablets have been <a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206143">discontinued</a> by Amgen. The tablets will still be available from multiple generic suppliers. This recall is part of the same Amgen recall involving Sensipar (Cinacalcet) Tablets.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99077">FDA Enforcement Report</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Duloxetine Delayed-Release Capsules (generic for Cymbalta)</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Company</strong>: Direct Rx, Dawsonville, Georgia<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 263 bottles (30-count and 60-count) 30 mg capsules<br><strong>Drug Purpose</strong>: Antidepressant<br><strong>Recall Reason</strong>: Presence of nitrosamine impurities above the FDA-recommended limit.<a href="https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications"> Nitrosamine impurities</a> may increase the risk of cancer.<br><strong>Recall Date</strong>: June 22, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99269">FDA Enforcement Report</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Fenofibrate Capsules</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Company</strong>: Ajanta Pharma USA Inc.<br><strong>Manufacturing Location</strong>: India by Ajanta Pharma Limited<br><strong>Scope</strong>: 3,648 bottles (100-count) 200 mg capsules<br><strong>Drug Purpose</strong>: A <a href="https://medlineplus.gov/ency/patientinstructions/000789.htm">fibrate medication</a> to help lower high triglycerides and increase levels of “good” (HDL) cholesterol<br><strong>Recall Reason</strong>: CGMP (Current Good Manufacturing Practice) deviations; this could affect product quality.<br><strong>Recall Date</strong>: May 28, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99130">FDA Enforcement Report</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Focalin XR (dexmethylphenidate HCl) Capsules</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Company</strong>: Sandoz Inc.<br><strong>Manufacturing Location</strong>: Gainesville, Georgia by Societal CDMO Gainesville, LLC<br>Scope: 7,803 bottles (30-count) 5 mg capsules<br><strong>Drug Purpose</strong>: Treats ADHD (Attention-deficit/hyperactivity disorder)<br><strong>Recall Reason</strong>: Labeling issue; incorrect or missing lot and/or expiration date.<br><strong>Recall Date</strong>: June 1, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99121">FDA Enforcement Report</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Lacosamide Tablets (generic for Vimpat)</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Company</strong>: Annora Pharma Pvt. Ltd.<br><strong>Manufacturing Location</strong>: Sangareddy, Telangana, India for Camber Pharmaceuticals, Inc., Piscataway, New Jersey<br><strong>Scope</strong>: 31,392 (60-count) bottles of 100 mg tablets<br><strong>Drug Purpose</strong>: Seizure treatment<br><strong>Recall Reason</strong>: Product mix-up: complaint of a Selexipag 1000 mcg tablet in a bottle of Lacosamide 100 mg. Selexipag treats pulmonary arterial hypertension.<br><strong>Recall Date</strong>: June 4, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?event=99200?Product=221039">FDA Enforcement Repor</a><a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?event=99200">t</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Nicotine Transdermal System Patch, 14 mg</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Company</strong>: Aveva Drug Delivery Systems<br><strong>Manufacturing Location</strong>: Not specified; distributed by Rugby Laboratories, Indianapolis, Indiana<br><strong>Scope</strong>: 59,808 patches 14 mg strength (4,272 individual 14-count cartons)<br><strong>Drug Purpose</strong>: Nicotine replacement therapy used to help people stop smoking. The 14 mg strength is “Step 2” of a three-part quit-smoking system.<br><strong>Recall Reason</strong>: Impurities (“Oxidative-related”) exceeded shelf-life limits during stability testing; this could affect drug's effectiveness and shelf life.<br><strong>Recall Date</strong>: May 14, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98972">FDA Enforcement Report</a> </p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Methylergonovine Maleate Tablets (generic for Methergine)</h3>
<!-- /wp:heading --><!-- wp:paragraph -->
<p><strong>Company</strong>: Harvard Drug Group; Packaged and distributed by Major Pharmaceuticals, Indianapolis, Indiana<br><strong>Manufacturing Location</strong>: Chantilly, Virginia by Granules Pharmaceuticals<br><strong>Scope</strong>: 790 cartons (about 16,000 20-count blister packs) of 0.2 mg tablets<br><strong>Drug Purpose</strong>: Prevents or reduces postpartum bleeding<br><strong>Recall Reason</strong>: Subpotent; the amount of active ingredient was less than the allowable range. <strong>Recall Date</strong>: May 27, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221127">Enforcement Report</a></p>
<!-- /wp:paragraph --><!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">PRED MILD (Prednisolone Acetate Ophthalmic Suspension)</h3>
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<p><strong>Company</strong>: AbbVie Inc.; Allergen, Inc. (an AbbVie company)<br><strong>Manufacturing Location</strong>: France<br><strong>Scope</strong>: 2,736 bottles (0.12%, 10 mL)<br><strong>Drug Purpose</strong>: Steroid eye drop used to treat eye inflammation<br><strong>Recall Reason</strong>: Failed stability specifications; this could affect the drug's effectiveness and shelf life.<br><strong>Recall Date</strong>: May 18, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220500">FDA Enforcement Report</a> </p>
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<h3 class="wp-block-heading">Prednisolone Acetate Ophthalmic Suspension, USP, 1%</h3>
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<p><strong>Company</strong>: Lupin Pharmaceuticals Inc.<br><strong>Manufacturing Location</strong>: Pithampur, India by Lupin Limited<br><strong>Scope</strong>: 2,530,182 bottles of 5 mL, 10 mL, and 15 mL prednisolone acetate ophthalmic suspension<br><strong>Drug Purpose</strong>: Steroid eye drop used to treat eye inflammation<br><strong>Recall Reason</strong>: Presence of foreign substance (Because this recall was just announced on July 1, 2026, there are no additional details listed at the time of publication).<br><strong>Recall Date</strong>: June 4, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=99144">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Sensipar (Cinacalcet) Tablets</h3>
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<p><strong>Company</strong>: Amgen Inc., Thousand Oaks, California<br><strong>Manufacturing Location</strong>: Japan<br><strong>Scope</strong>: 9,565 bottles (30-count) 30 mg tablets; unspecified number of bottles of 60 mg and 90 mg tablets<br><strong>Drug Purpose</strong>: Treats <a href="https://medlineplus.gov/ency/article/001215.htm">hyperparathyroidism</a>, a condition in which one or more of the parathyroid glands in the neck produce too much parathyroid hormone.<br><strong>Recall Reason</strong>: CGMP (Current Good Manufacturing Practice) deviations, which could affect drug quality.<br><strong>Recall Date</strong>: June 4, 2026<br><strong>Essential Extras</strong>: Sensipar (Cinacalcet) Tablets have been <a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021688">discontinued</a> by Amgen. The tablets will still be available from multiple generic suppliers. This recall is part of the same Amgen recall involving Corlanor (Ivabradine) tablets.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99077">FDA Enforcement Report</a> </p>
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FDA Recalls and Warnings: Foreign Substance Found in Millions of Steroid Eye Drops, Seizure Drug Mix-Up & More

How to Read This Report

Drug Recalls

Aripiprazole Tablets (generic for Abilify)