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Shedding Light on the Risks
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Shedding Light on the Risks
& Benefits of Medications FDA Recalls and Warnings: Generic Cymbalta Cancer Risk, Metoprolol Dissolution Issues, and More
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Get the latest FDA updates on medication recalls, manufacturing violations, and quality concerns that could affect your prescriptions
May 21, 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 Duloxetine, Enalapril Maleate, Freshkote Lubricant Eye Drops, Metoprolol Succinate, MG217 Multi-symptom Treatment Cream & Skin Protectant Eczema Cream, Naproxen Oral Suspension, and Oasis Tears PF Preservative-Free Lubricant Eye Drops.
The recall of MG217 Multi-Symptom Treatment Cream was announced in an FDA press release on behalf of the manufacturer, Pharmacal, and is directed at consumers. Although the recall has not yet been formally classified, it will likely receive a Class I designation because of the potential severity of the risk.
All other recalls in this installment are nationwide Class II recalls and were not issued directly to consumers. Consumers may still want to review the linked enforcement reports for affected lot numbers and expiration dates.
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
Duloxetine Delayed-Release Capsules (generic for Cymbalta)
Company: Breckenridge Pharmaceutical
Manufacturing Location: Martorelles (Barcelona), Spain, by Towa Pharmaceutical Europe S.L.
Scope: 165,761 bottles of 60 mg capsules (90-count)
Drug Purpose: Antidepressant
Recall Reason: Presence of nitrosamine impurities above the FDA-recommended limit. Nitrosamine impurities may increase the risk of cancer.
Recall Initiation Date: April 21, 2026
Link: FDA Enforcement Report
Duloxetine Delayed-Release Capsules (generic for Cymbalta)
Company: Ajanta Pharma Ltd.
Manufacturing Location: India
Scope: 117,168 packs (20 mg, 60 capsules per pack); 312,894 packs (30 mg, 90, 30, and 1000 capsules per pack)
Drug Purpose: Antidepressant
Recall Reason: Nitrosamine impurities were detected above the FDA’s recommended limit during 12- and 18-month long-term stability testing. Nitrosamines are chemical compounds that may increase the risk of cancer. Because the impurities were identified during later-stage stability testing, the recall affects products with expiration dates in May and June 2026.
Recall Initiation Date: April 29, 2026
Link: FDA Enforcement Report
Duloxetine Delayed-Release Capsules (generic for Cymbalta)
Company: Ajanta Pharma Ltd.
Manufacturing Location: India
Scope: 77,376 packs (60 mg, 30 capsules per pack)
Drug Purpose: Antidepressant
Recall Reason: Nitrosamine impurities were detected above the FDA’s recommended limit during 12- and 18-month long-term stability testing. Nitrosamines are chemical compounds that may increase the risk of cancer. Because the impurities were identified during later-stage stability testing, the recall affects products with expiration dates in May and June 2026.
Recall Initiation Date: April 29, 2026
Link: FDA Enforcement Report
Enalapril Maleate Tablets
Company: JB Chemicals & Pharmaceuticals Ltd. Rising Pharma Holdings, Inc.
Manufacturing Location: Mumbai, India, by JB Chemical’s Unique Pharmaceutical Laboratories; distributed by Rising Pharma Holdings, Inc.
Scope: 675 bottles (1,000-count) of 20 mg strength
Drug Purpose: ACE Inhibitor that treats high blood pressure and heart failure
Recall Reason: Failed impurities and degradation specifications; this could affect product quality and shelf life.
Recall Initiation Date: April 23, 2026
Link: FDA Enforcement Report
Freshkote Lubricant Eye Drops
Company: Harrow Eye, LLC
Manufacturing Location: France
Scope: 50,900 bottles (0.33 fl oz / 10 mL)
Drug Purpose: Lubricating eye drops used to relieve dry or irritated eyes
Recall Reason: Lack of assurance of sterility; the products may not have been manufactured under proper sterile conditions.
Recall Initiation Date: April 17, 2026
Link: FDA Enforcement Report
Metoprolol Succinate Extended-Release Tablets
Company: Ascend Laboratories
Manufacturing Location: India by Alkem Laboratories
Scope: 17,304 bottles (100-count) of 25 mg strength
Drug Purpose: Beta-blocker used to treat high blood pressure, chest pain, and certain heart conditions
Recall Reason: Failed dissolution specification; the tablets may not dissolve properly, potentially reducing their effectiveness.
Recall Initiation Date: April 27, 2026
Link: FDA Enforcement Report
MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream
Company: Pharmacal
Manufacturing Location: Not specified
Scope: One lot of 6-ounce tubes sold over-the-counter and distributed nationwide to wholesale, retail (H-E-B Grocery), and internet distributors (Amazon)
Drug Purpose: Topical cream treats eczema, skin irritation, and rash
Recall Reason: The product may be contaminated with Staphylococcus aureus, a type of bacteria that can cause infections ranging from localized skin reactions to severe or potentially life-threatening illness.
Recall Initiation Date: May 8, 2026; not yet classified
Link: FDA Press Release
Check the FDA press release for product image and company contact information.
Naproxen Oral Suspension
Company: Acella Pharmaceuticals
Manufacturing Location: Canada
Scope: 6,336 bottles of 125 mg/5 mL, strength, 16 fl oz (473 mL)
Drug Purpose: A prescription nonsteroidal anti-inflammatory drug (NSAID) liquid formulation used to treat pain, inflammation, and fever.
Recall Reason: Chemical contamination with lead and lithium above allowed amounts
Recall Initiation Date: April 20, 2026
Link: FDA Enforcement Report
Oasis Tears PF, Preservative-Free Lubricant Eye Drops
Company: Oasis Medical
Manufacturing Location: France by Manufacturer Excelvision
Scope: Unspecified quantity; 10 mL / 0.34 fl oz bottle
Drug Purpose: Lubricating eye drops used to relieve dry or irritated eyes
Recall Reason: Lack of assurance of sterility; the recall is being initiated out of an abundance of caution following FDA observations during a recent inspection of the manufacturing facility, Excelvision.
Recall Initiation Date: April 27, 2026
Essential Extras: In May 2025, the FDA issued a Warning Letter to the Excelvision manufacturing facility in Ardèche, France, after inspectors identified significant violations of Current Good Manufacturing Practice (CGMP) regulations. The inspection uncovered problems involving the facility’s aseptic and sterilization processes, inadequate investigations into customer complaints, and other quality-control failures. The company notes that it has halted production, and the FDA has outlined the corrective actions required to resume manufacturing.
Link: FDA Enforcement Report
Want to Share Your Story?
If you’ve experienced side effects or medication issues related to this topic, we want to hear from you.
Submit Your Story- Research, C. F. D. E. A. (2024, September 4). Information about Nitrosamine Impurities in Medications. U.S. Food And Drug Administration.
- 21 CFR Part 211 -- Current good manufacturing practice for finished Pharmaceuticals. (n.d.).
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<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 Duloxetine, Enalapril Maleate, Freshkote Lubricant Eye Drops, Metoprolol Succinate, MG217 Multi-symptom Treatment Cream & Skin Protectant Eczema Cream, Naproxen Oral Suspension, and Oasis Tears PF Preservative-Free Lubricant Eye Drops.</p>
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<p>The recall of MG217 Multi-Symptom Treatment Cream was announced in an FDA press release on behalf of the manufacturer, Pharmacal, and is directed at consumers. Although the recall has not yet been formally classified, it will likely receive a Class I designation because of the potential severity of the risk.</p>
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<p>All other recalls in this installment are nationwide Class II recalls and were not issued directly to consumers. Consumers may still want to review the linked enforcement reports for affected lot numbers and expiration dates.</p>
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<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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<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>
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<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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<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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<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>
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<h3 class="wp-block-heading">Duloxetine Delayed-Release Capsules (generic for Cymbalta)</h3>
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<p><strong>Company</strong>: Breckenridge Pharmaceutical<br><strong>Manufacturing Location</strong>: Martorelles (Barcelona), Spain, by Towa Pharmaceutical Europe S.L.<br><strong>Scope</strong>: 165,761 bottles of 60 mg capsules (90-count)<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 Initiation Date</strong>: April 21, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219850">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Duloxetine Delayed-Release Capsules (generic for Cymbalta)</h3>
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<p><strong>Company</strong>: Ajanta Pharma Ltd.<br><strong>Manufacturing Location</strong>: India<br><strong>Scope</strong>: 117,168 packs (20 mg, 60 capsules per pack); 312,894 packs (30 mg, 90, 30, and 1000 capsules per pack)<br><strong>Drug Purpose</strong>: Antidepressant<br><strong>Recall Reason</strong>: Nitrosamine impurities were detected above the FDA’s recommended limit during 12- and 18-month long-term stability testing. <a href="https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications">Nitrosamines</a> are chemical compounds that may increase the risk of cancer. Because the impurities were identified during later-stage stability testing, the recall affects products with expiration dates in May and June 2026.<br><strong>Recall Initiation Date</strong>: April 29, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98785">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Duloxetine Delayed-Release Capsules (generic for Cymbalta)</h3>
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<p><strong>Company</strong>: Ajanta Pharma Ltd.<br><strong>Manufacturing Location</strong>: India<br><strong>Scope</strong>: 77,376 packs (60 mg, 30 capsules per pack)<br><strong>Drug Purpose</strong>: Antidepressant<br><strong>Recall Reason</strong>: Nitrosamine impurities were detected above the FDA’s recommended limit during 12- and 18-month long-term stability testing. <a href="https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications">Nitrosamines</a> are chemical compounds that may increase the risk of cancer. Because the impurities were identified during later-stage stability testing, the recall affects products with expiration dates in May and June 2026.<br><strong>Recall Initiation Date</strong>: April 29, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98785">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Enalapril Maleate Tablets</h3>
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<p><strong>Company</strong>: JB Chemicals & Pharmaceuticals Ltd. Rising Pharma Holdings, Inc.<br><strong>Manufacturing Location</strong>: Mumbai, India, by JB Chemical’s Unique Pharmaceutical Laboratories; distributed by Rising Pharma Holdings, Inc.<br><strong>Scope</strong>: 675 bottles (1,000-count) of 20 mg strength<br><strong>Drug Purpose</strong>: ACE Inhibitor that treats high blood pressure and heart failure<br><strong>Recall Reason</strong>: Failed impurities and degradation specifications; this could affect product quality and shelf life.<br><strong>Recall Initiation Date</strong>: April 23, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?event=98794?Product=219842">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Freshkote Lubricant Eye Drops</h3>
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<p><strong>Company</strong>: Harrow Eye, LLC<br><strong>Manufacturing Location</strong>: France<br><strong>Scope</strong>: 50,900 bottles (0.33 fl oz / 10 mL)<br><strong>Drug Purpose</strong>: Lubricating eye drops used to relieve dry or irritated eyes<br><strong>Recall Reason</strong>: Lack of assurance of sterility; the products may not have been manufactured under proper sterile conditions.<br><strong>Recall Initiation Date</strong>: April 17, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219747">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Metoprolol Succinate Extended-Release Tablets</h3>
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<p><strong>Company</strong>: Ascend Laboratories<br><strong>Manufacturing Location</strong>: India by Alkem Laboratories<br><strong>Scope</strong>: 17,304 bottles (100-count) of 25 mg strength<br><strong>Drug Purpose</strong>: Beta-blocker used to treat high blood pressure, chest pain, and certain heart conditions<br><strong>Recall Reason</strong>: Failed dissolution specification; the tablets may not dissolve properly, potentially reducing their effectiveness.<br><strong>Recall Initiation Date</strong>: April 27, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?event=98821?Product=219887">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream</h3>
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<p><strong>Company</strong>: Pharmacal<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: One lot of 6-ounce tubes sold over-the-counter and distributed nationwide to wholesale, retail (H-E-B Grocery), and internet distributors (Amazon)<br><strong>Drug Purpose</strong>: Topical cream treats eczema, skin irritation, and rash <br><strong>Recall Reason</strong>: The product may be contaminated with Staphylococcus aureus, a type of bacteria that can cause infections ranging from localized skin reactions to severe or potentially life-threatening illness. <br><strong>Recall Initiation Date</strong>: May 8, 2026; not yet classified<br><strong>Link</strong>: <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmacal-issues-nationwide-recall-mg217-multi-symptom-treatment-cream-skin-protectant-eczema-cream">FDA Press Release</a><br>Check the FDA press release for product image and company contact information.</p>
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<h3 class="wp-block-heading">Naproxen Oral Suspension</h3>
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<p><strong>Company</strong>: Acella Pharmaceuticals<br><strong>Manufacturing Location</strong>: Canada<br><strong>Scope</strong>: 6,336 bottles of 125 mg/5 mL, strength, 16 fl oz (473 mL)<br><strong>Drug Purpose</strong>: A prescription nonsteroidal anti-inflammatory drug (NSAID) liquid formulation used to treat pain, inflammation, and fever.<br><strong>Recall Reason</strong>: Chemical contamination with lead and lithium above allowed amounts<br><strong>Recall Initiation Date</strong>: April 20, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219776">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Oasis Tears PF, Preservative-Free Lubricant Eye Drops</h3>
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<p><strong>Company</strong>: Oasis Medical<br><strong>Manufacturing Location</strong>: France by Manufacturer Excelvision<br><strong>Scope</strong>: Unspecified quantity; 10 mL / 0.34 fl oz bottle<br><strong>Drug Purpose</strong>: Lubricating eye drops used to relieve dry or irritated eyes<br><strong>Recall Reason</strong>: Lack of assurance of sterility; the recall is being initiated out of an abundance of caution following FDA observations during a recent inspection of the manufacturing facility, Excelvision.<br><strong>Recall Initiation Date</strong>: April 27, 2026<br><strong>Essential Extras</strong>: In May 2025, the FDA issued <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/excelvision-fareva-703245-05072025">a Warning Letter</a> to the Excelvision manufacturing facility in Ardèche, France, after inspectors identified significant violations of Current Good Manufacturing Practice (CGMP) regulations. The inspection uncovered problems involving the facility’s aseptic and sterilization processes, inadequate investigations into customer complaints, and other quality-control failures. The company notes that it has halted production, and the FDA has outlined the corrective actions required to resume manufacturing.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220111">FDA Enforcement Report</a></p>
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