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FDA recalls of prescription and over-the-counter drugs.
FDA drug recalls cover prescription medicines, over-the-counter products, biologic and gene therapies, and active pharmaceutical ingredients (the raw drug substances that manufacturers compound into finished products). Recall classifications follow the same Class I / II / III system as food, and most published recalls are Class II — the product is unlikely to cause permanent harm but doesn't meet specification.
The most common reasons for a drug recall are out-of-specification potency or dissolution (the active ingredient is present in too high or too low a dose), microbial contamination, particulate matter in injectables, mix-ups during packaging where bottles end up with the wrong tablets, and nitrosamine impurities in certain drug classes. Many drug recalls are at the lot level — the manufacturer's whole product line is still safe to use, but specific production lots are pulled.
If a recall affects your medication: don't stop taking it on your own. Call your prescriber or pharmacist before doing anything. Stopping a prescribed drug abruptly can be more dangerous than the issue prompting the recall. Most drug-recall remedies route through the dispensing pharmacy, who'll either swap your supply for an unaffected lot or coordinate a refund with the manufacturer.
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets (150 mg), lot HAD0360A, due to failed dissolution specifications. The 144 bottles were distributed nationwide and may not dissolve at the intended rate.
Dollar Tree Distribution recalled approximately 4.3 million over-the-counter drug products sold by Family Dollar stores nationwide after discovering they were stored outside of labeled temperature requirements.
The FDA is recalling BREXAFEMME antifungal tablets due to potential cross-contamination with ezetimibe during manufacturing, with two lot numbers distributed nationwide.
Dr. Berne's MSM DROPS 5% Solution was recalled by the FDA for non-sterility issues. Lot 6786, with expiration date March 31, 2025, is distributed nationwide and internationally.
Central Admixture Pharmacy Services is recalling 403 bags of fentanyl injection due to lack of sterility assurance. The affected lots were distributed nationwide.
Central Admixture Pharmacy Services is recalling 1,590 syringes of ePHEDrine due to lack of assurance of sterility. The product was distributed nationwide.
Central Admixture Pharmacy Services has recalled approximately 398 HYDROmorphone in dextrose 5% injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider immediately.
The FDA is recalling HYDROmorphone injectable syringes from Central Admixture Pharmacy Services Inc. due to lack of sterility assurance. Approximately 1,190 syringes nationwide are affected.
Central Admixture Pharmacy Services Inc. is recalling fentanyl injectable solution nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Central Admixture Pharmacy Services Inc is recalling 3,384 phenylephrine syringes due to lack of assurance of sterility. The product was distributed nationwide.
Imprimis NJOF is recalling an epinephrine-lidocaine injectable due to failed potency testing, affecting nationwide distribution. The product was compounded in April 2023 for use during eye surgery.
Central Admixture Pharmacy Services Inc. is recalling 688 units of fentanyl injection nationwide because it cannot assure the product meets sterility standards.
Central Admixture Pharmacy Services is recalling fentanyl injection product due to lack of sterility assurance. No illnesses have been reported.
The FDA is recalling rocuronium 50 mg/5 mL syringes from Central Admixture Pharmacy Services Inc due to lack of assurance of sterility. Approximately 1,389 syringes with affected lot numbers have been distributed nationwide.
Central Admixture Pharmacy Services Inc is recalling 3,590 succinylcholine 200 mg/10 mL syringes distributed nationwide due to lack of assurance of sterility. No illnesses have been reported.
Central Admixture Pharmacy Services is recalling fentanyl 10 mcg/mL injectable solution due to lack of assurance of sterility. The recall affects 1,767 three-milliliter syringes distributed nationwide.
Central Admixture Pharmacy Services is recalling fentanyl 100 mcg/2 mL syringes due to a lack of assurance of sterility. The affected lot was distributed nationwide.
Central Admixture Pharmacy Services is recalling fentanyl 50 mcg/mL injectable nationwide due to lack of assurance of sterility. The product was distributed in 100 mL bags (lot 17-275322, expires 10/3/2023).
CAPS Inc. is recalling 4,775 ketamine syringes nationwide due to lack of confirmed sterility assurance during manufacturing. No illnesses have been reported, but affected healthcare facilities should quarantine and return unused product.
Dr. Berne's Organic Castor Oil Eye Drops are being recalled due to manufacturing practice deviations. The voluntary recall affects 1,744 bottles distributed nationally and internationally.
Central Admixture Pharmacy Services is recalling midazolam injectable solution syringes due to lack of assurance of sterility. Patients should not use the affected lots and consult their healthcare provider.
Central Admixture Pharmacy Services Inc. is recalling hydromorphone syringes due to lack of assurance of sterility. The recall affects 274 syringes distributed nationwide.
Central Admixture Pharmacy Services is recalling 962 fentanyl in dextrose syringes distributed nationwide due to lack of assured sterility in the injectable pharmaceutical products.
Central Admixture Pharmacy Services is recalling lidocaine 2% injectables due to inability to assure sterility. Approximately 1,992 syringes distributed nationwide are affected.
Central Admixture Pharmacy Services is recalling 598 fentanyl syringes due to lack of assurance of sterility. The affected lots were distributed nationwide.
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