Recent FDA Drug Recalls - November 2025: Huge Duloxetine Recall, Bupropion, Niacin, More

(November 8, 2025)

Quick Links: Bupropion;  Carbidopa/Levodopa/Entacapone; Chlorpromzine; Duloxetine; Niacin; Compounded Semaglutide; Tylenol

Drug Recall: Bupropion Hydrochloride Extended-Release Tablets XL (Wellbutrin XL generic) by Graviti Pharmaceuticals

Graviti Pharmaceuticals is recalling 46,512 bottles of Bupropion Hydrochloride Extended-Release Tablets XL, 300 mg strength (30-count), distributed and packaged by Rising Pharma. The recall was triggered due to failure in critical quality control specifications. Bupropion XL, a generic for Zyban, is prescribed to help patients quit smoking. Bupropion is also used as an antidepressant. These tablets were manufactured in Sangareddy, Telangana, India. See the FDA Check the lot numbers using the FDA announcement.
Recall Announcement

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Drug Recall: Carbidopa, Levodopa, Entacapone Tablets by Rising Pharma

Rising Pharma Holdings is recalling 2,064 bottles of Carbidopa, Levodopa, and Entacapone tablets, 25 mg/100 mg/200 mg strength, 100-count bottles. Manufactured by Suven Pharmaceuticals Limited in Telangana, India, the recall follows complaints of product mix-up where some bottles labeled with the lower strength contained tablets of a higher strength (37.5 mg/150 mg/200 mg). The tablets are used for Parkinson’s disease. See FDA recall announcement for affected lots and dates.
Recall Announcement

 

Drug Recall: Chlorpromazine Hydrochloride Tablets by Major Pharmaceuticals

Major Pharmaceuticals is recalling 2,064 blister packs of Chlorpromazine Hydrochloride Tablets, 25 mg strength, 50 tablets per pack. Formerly branded as Thorazine, the tablets treat schizophrenia and mood disorders. The recall resulted from nitrosamine impurities exceeding FDA limits, which can increase cancer risk. Manufacturing location was not specified. Check the recall announcement for detailed lot and expiration information.
Recall Announcement

 

Drug Recall: Duloxetine Delayed-Release Capsules (Cymbalta generic) by Breckenridge Pharmaceutical

Breckenridge Pharmaceutical is recalling 172,263 bottles of antidepressant Duloxetine Delayed-Release Capsules, 60 mg strength (90-count and 1,000-count), manufactured by Towa Pharmaceutical Europe, Barcelona, Spain. The recall was due to nitrosamine impurities above FDA limits, a potential cancer risk. Refer to the FDA recall announcement for specific lot numbers and expiration dates.
Recall Announcement

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Drug Recall: Niacin Extended-Release Tablets by Lannett Company

Lannett Company is recalling 46,848 bottles of Niacin Extended-Release Tablets, 1,000 mg strength (90-count). The products failed dissolution specifications, which may impact their effectiveness by not dissolving properly after storage. Niacin is used to manage cholesterol levels. See the announcement for lot numbers and expiration dates.
Recall Announcement

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Drug Recall: Compounded Semaglutide & Tirzepatide by ProRx LLC

ProRx LLC, a licensed compounding pharmacy in Exton, Pennsylvania, is recalling more than 36,000 multidose vials of semaglutide and 2,761 vials of tirzepatide distributed primarily in Texas and Utah. Both drugs are used to treat type 2 diabetes and obesity. The recall was issued due to lack of assurance of sterility.
Recall Announcement

 

Drug Recall: Compounded Semaglutide, Tirzepatide, Retatrutide, and Vitamin Injectables by GenoGenix LLC

GenoGenix LLC, a compounding pharmacy in Boca Raton, FL, has recalled multiple compounded injectable medications, including semaglutide, tirzepatide, retatrutide, semaglutide with vitamin B12, and 54 other products such as vitamin blends. The recall was due to lack of assurance of sterility. Note that retatrutide is an experimental drug not approved for compounding use and is associated with obesity treatment. The recall began July 30, 2025, but FDA just recently classified it in October 2025 as a class II recall.
Recall Announcement

 

Drug Recall: Tylenol (Acetaminophen 500 mg) by Kenvue Brands, LLC

Kenvue Brands is recalling 3,816 bottles of Acetaminophen 500 mg caplets, 24-count, distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. The recall is due to defective containers. Tylenol is a commonly used pain reliever and fever reducer.
Recall Announcement

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Note: Recall information is from FDA Enforcement Reports, which are linked. Check the announcements for specific lot numbers and expiration dates. The recalls on this page are classified as Class II level, the middle urgency type of recall because the probability of serious adverse health consequences is remote. The recalls are also directed at the supplier level, not the consumer, but consumers may want to check the announcements to make sure they do not have product that was distributed prior to the recall announcement.