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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 Adderall XR Mix-Up, Subpotent Levothyroxine, Moringa Supplements Tainted with Salmonella
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Get the latest FDA updates on medication recalls, manufacturing violations, and quality concerns that could affect your prescriptions
July 13, 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 drug recalls for Cinacalcet, Dextroamphetamine Saccharate/Amphetamine Aspartate Monohydrate/Dextroamphetamine Sulfate/Amphetamine Sulfate (Adderall XR generic), Glucagon Emergency Kit for Low Blood Sugar, and Levothyroxine.
Two dietary supplements are also under recall: Organic Moringa Leaf Powder and Organic Moringa Leaf Capsules.
All recalls in this installment are nationwide “Class II” recalls, except for Organic Moringa Leaf Powder, which is a Class I recall, and Organic Moringa Leaf Capsules and Glucagon Emergency Kit, which have not yet been classified. 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
Cinacalcet Hydrochloride Tablets (generic for Sensipar)
Company: Cipla USA, Inc.
Manufacturing Location: Patalganga, India by Cipla Ltd.
Scope: 31,824 bottles (30-count) 30 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: Presence of nitrosamine impurities above the FDA-recommended limit. Nitrosamine impurities may increase the risk of cancer.
Recall Date: Initiated June 29, 2026
Link: FDA Enforcement Report
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules (generic for Adderall XR)
Company: Lannett Company, Inc.
Manufacturing Location: Not specified
Scope: 1,392 bottles (100-count) 5 mg capsules
Drug Purpose: Treats ADHD (Attention-deficit/hyperactivity disorder)
Recall Reason: Labeling mix-up; capsules contain immediate-release pellets but are labeled as extended-release.
Recall Date: June 26, 2026
Link: FDA Enforcement Report
Glucagon Emergency Kit for Low Blood Sugar
Company: Lupin Pharmaceuticals Inc.
Manufacturing Location: Nagpur, India, by Lupin Limited
Scope: 64,894 units of 1 mg vials with syringe
Drug Purpose: Emergency treatment for severe low blood sugar in people with diabetes
Recall Reason: An out-of-specification result was found in the “Gliding Force functionality test” during long-term stability testing at 12 months. The syringe may not deliver the dose smoothly and reliably.
Recall Date: June 23, 2026
Link: FDA Enforcement Report (recall not yet classified)
Levothyroxine Sodium Tablets (generic for Synthroid)
Company: Accord Healthcare, Inc.
Manufacturing Location: Selaqui, India by Intas Pharmaceuticals Limited
Scope: 6,432 bottles (90-count) of 300 mcg (0.3mg) tablets
Drug Purpose: Thyroid hormone replacement to treat hypothyroidism
Recall Reason: Subpotent; the amount of active ingredient was less than the allowable range.
Essential Extras: Accord had a similar levothyroxine recall in September 2025.
Recall Date: June 8, 2026
Link: FDA Enforcement Report
Organic Moringa Leaf Powder
Company: Trafa Pharmaceutical Inc., Chicopee, MA
Manufacturing Location: Not specified
Scope: 500 kg (1,102 pounds) of powder (one batch) packaged in 15 kg brown paper bags with white label
Supplement Purpose: Used in dietary supplement products such as moringa leaf capsules. Moringa is a tropical tree native to India that is often promoted for its nutritional and health benefits.
Recall Reason: Powder may be contaminated with Salmonella. Most people infected with Salmonella experience diarrhea, fever, and stomach cramps, with symptoms usually within 72 hours after swallowing the bacteria. Although most people recover without treatment after 4 to 7 days, some people, such as young children, the elderly, or the immunocompromised, can become seriously ill.
Recall Date: June 24, 2026
Link: FDA Enforcement Report
TNVitamins 100% Organic Moringa 1,200 mg Capsules and 100% Organic Moringa Powder
Company: Total Nutrition Inc.
Manufacturing Location: Not specified
Scope: One lot of capsules (90-count bottle of clear capsules containing green organic moringa powder) and one lot of powder (white jar with a smooth white cap containing 96 grams of green organic moringa powder)
Supplement Purpose: A dietary supplement made from powdered moringa leaves. Moringa is a tropical tree native to India that is often promoted for its nutritional and health benefits.
Recall Reason: Product may be contaminated with Salmonella. Most people infected with Salmonella experience diarrhea, fever, and stomach cramps, with symptoms usually within 72 hours after swallowing the bacteria. Although most people recover without treatment after 4 to 7 days, some people, such as young children, the elderly, or the immunocompromised, can become seriously ill.
Recall Initiation Date: June 26, 2026; not yet classified
Essential Extras: This is part of a larger recall of moringa leaf powder products that began in January 2026. The products were distributed nationally through the online platforms Amazon, Walmart, TikTok Shop, Target, and the company’s website, http://www.tnvitamins.com/. No illnesses for this product have been reported as of the press release date. The FDA and Centers for Disease Control (CDC) are conducting a joint investigation into Salmonella cases associated with moringa-containing dietary supplement products.
Link: FDA Press Release (June 26, 2026) and company website: Notice: Recall and Refund Request (No FDA enforcement report available; recall not yet classified.)
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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 drug recalls for Cinacalcet, Dextroamphetamine Saccharate/Amphetamine Aspartate Monohydrate/Dextroamphetamine Sulfate/Amphetamine Sulfate (Adderall XR generic), Glucagon Emergency Kit for Low Blood Sugar, and Levothyroxine. </p>
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<p>Two dietary supplements are also under recall: Organic Moringa Leaf Powder and Organic Moringa Leaf Capsules. </p>
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<p>All recalls in this installment are nationwide “Class II” recalls, except for Organic Moringa Leaf Powder, which is a Class I recall, and Organic Moringa Leaf Capsules and Glucagon Emergency Kit, which have not yet been classified. 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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<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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<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.<br></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">Cinacalcet Hydrochloride Tablets (generic for Sensipar)</h3>
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<p><strong>Company</strong>: Cipla USA, Inc.<br><strong>Manufacturing Location</strong>: Patalganga, India by Cipla Ltd.<br><strong>Scope</strong>: 31,824 bottles (30-count) 30 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>: 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>: Initiated June 29, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99350">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules (generic for Adderall XR)</h3>
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<p><strong>Company</strong>: Lannett Company, Inc.<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 1,392 bottles (100-count) 5 mg capsules<br><strong>Drug Purpose</strong>: Treats ADHD (Attention-deficit/hyperactivity disorder)<br><strong>Recall Reason</strong>: Labeling mix-up; capsules contain immediate-release pellets but are labeled as extended-release.<br><strong>Recall Date</strong>: June 26, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221274">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Glucagon Emergency Kit for Low Blood Sugar</h3>
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<p><strong>Company</strong>: Lupin Pharmaceuticals Inc.<br><strong>Manufacturing Location</strong>: Nagpur, India, by Lupin Limited<br><strong>Scope</strong>: 64,894 units of 1 mg vials with syringe<br><strong>Drug Purpose</strong>: Emergency treatment for severe low blood sugar in people with diabetes<br><strong>Recall Reason</strong>: An out-of-specification result was found in the “Gliding Force functionality test” during long-term stability testing at 12 months. The syringe may not deliver the dose smoothly and reliably.<br><strong>Recall Date</strong>: June 23, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99296">FDA Enforcement Report</a> (recall not yet classified)</p>
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<h3 class="wp-block-heading">Levothyroxine Sodium Tablets (generic for Synthroid)</h3>
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<p><strong>Company</strong>: Accord Healthcare, Inc.<br><strong>Manufacturing Location</strong>: Selaqui, India by Intas Pharmaceuticals Limited<br><strong>Scope</strong>: 6,432 bottles (90-count) of 300 mcg (0.3mg) tablets<br><strong>Drug Purpose</strong>: Thyroid hormone replacement to treat hypothyroidism<br><strong>Recall Reason</strong>: Subpotent; the amount of active ingredient was less than the allowable range.<br><strong>Essential Extras</strong>: Accord had a <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=97613">similar </a>levothyroxine recall in September 2025.<br><strong>Recall Date</strong>: June 8, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99194">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Organic Moringa Leaf Powder</h3>
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<p><strong>Company</strong>: Trafa Pharmaceutical Inc., Chicopee, MA<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 500 kg (1,102 pounds) of powder (one batch) packaged in 15 kg brown paper bags with white label<br><strong>Supplement Purpose</strong>: Used in dietary supplement products such as moringa leaf capsules. Moringa is a tropical tree native to India that is often promoted for its nutritional and health benefits.<br><strong>Recall Reason</strong>: Powder may be contaminated with Salmonella. Most people infected with Salmonella experience diarrhea, fever, and stomach cramps, with symptoms usually within 72 hours after swallowing the bacteria. Although most people recover without treatment after 4 to 7 days, some people, such as young children, the elderly, or the immunocompromised, can become seriously ill.<br><strong>Recall Date</strong>: June 24, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99314">FDA Enforcement Report</a> </p>
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<h3 class="wp-block-heading">TNVitamins 100% Organic Moringa 1,200 mg Capsules and 100% Organic Moringa Powder</h3>
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<p><strong>Company</strong>: Total Nutrition Inc.<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: One lot of capsules (90-count bottle of clear capsules containing green organic moringa powder) and one lot of powder (white jar with a smooth white cap containing 96 grams of green organic moringa powder)<br><strong>Supplement Purpose</strong>: A dietary supplement made from powdered moringa leaves. Moringa is a tropical tree native to India that is often promoted for its nutritional and health benefits.<br><strong>Recall Reason</strong>: Product may be contaminated with Salmonella. Most people infected with Salmonella experience diarrhea, fever, and stomach cramps, with symptoms usually within 72 hours after swallowing the bacteria. Although most people recover without treatment after 4 to 7 days, some people, such as young children, the elderly, or the immunocompromised, can become seriously ill.<br><strong>Recall Initiation Date</strong>: June 26, 2026; not yet classified<br><strong>Essential Extras</strong>: This is part of a <a href="https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-moringa-leaf-powder-january-2026">larger recall</a> of moringa leaf powder products that began in January 2026. The products were distributed nationally through the online platforms Amazon, Walmart, TikTok Shop, Target, and the company's website, <a href="http://www.tnvitamins.com/">http://www.tnvitamins.com/</a>. No illnesses for this product have been reported as of the press release date. The FDA and Centers for Disease Control (CDC) are conducting a<a href="https://www.cdc.gov/salmonella/outbreaks/supergreenssupplementpowders-1-26/index.html"> joint investigation</a> into Salmonella cases associated with moringa-containing dietary supplement products.<br><strong>Link</strong>: <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/total-nutrition-inc-recalls-organic-moringa-products-following-supplier-initiated-recall-due#recall-announcement">FDA Press Release</a> (June 26, 2026) and company website: <a href="https://tnvitamins.com/pages/recall?_pos=1&_sid=5157c3e5e&_ss=r">Notice: Recall and Refund Request</a> (No FDA enforcement report available; recall not yet classified.)</p>
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