Category
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.
Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility and bacterial contamination detected in some media fill units. The drug is used for intramuscular injection to treat psychiatric conditions.
Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility and bacterial contamination detected in some media fill units. The affected product was distributed nationwide.
Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection vials nationwide because some media fill units showed bacterial contamination, indicating a lack of sterility assurance. The affected product is a 100mg/mL injectable antipsychotic medication.
Leiters Health is recalling dexmedetomidine HCl PF syringes nationwide due to leaking or damaged syringes that may not maintain sterility. Affected lot 2431276A has an expiration date of 4/20/2025.
Denver Solutions, LLC DBA Leiters Health is recalling Rocuronium Bromide 50 mg per 5mL syringes due to potential leaking or damage that may compromise sterility assurance.
Denver Solutions, LLC (DBA Leiters Health) is recalling Glycopyrrolate 1mg/5mL single-dose syringes (Lot #2431015B, expiration 4/10/2025) distributed nationwide because some syringes were found to be leaking or damaged, which compromises sterility assurance.
Supplement Manufacturing Partner Inc. is recalling Spermidine Maximum Strength 10 mg dietary supplement (Lot 12792402-44) because it contains undeclared wheat, a major allergen not listed on the label.
Lupin Pharmaceuticals is recalling Clomipramine Hydrochloride Capsules (25 mg) due to an unspecified degradation product detected in stability testing. The defect was identified during an 18-month long-term stability study.
Pharmadel, LLC is recalling Kingskin salicylic acid wart-removal solution due to cGMP manufacturing deviations. The recall affects 20,048 bottles distributed in Delaware.
OurPharma LLC is recalling HYDROmorphone Hydrochloride 50 mg/50 mL cassettes nationwide because the assay results showed higher potency than specification.
Pharmadel is recalling 6,048 bottles of Rapidol Arnica Tablets homeopathic medicine due to current good manufacturing practice (cGMP) deviations. The recall affects bottles with lot EAT-01, expiration date March 27, distributed in Delaware.
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules nationwide due to elevated levels of a nitrosamine-related impurity that exceed the FDA's interim safety limit. The affected lots include bottles with expiration dates in April 2027.
Medisca Inc. is voluntarily recalling Bimatoprost bulk powder in three sizes due to manufacturing process deviations. The powder was distributed nationwide.
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 30 mg nationwide due to the presence of a nitrosamine drug substance related impurity above proposed interim limits.
Apipharma is voluntarily recalling Hemopropin Ointment due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects specific lot numbers distributed in Arizona.
Pharmadel, LLC is recalling DoloDent Maximum Strength Toothache Drops due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall affects 9,504 bottles distributed in Delaware.
Pharmadel, LLC is recalling Urodel homeopathic chewable tablets for urinary tract infection symptom relief due to cGMP manufacturing deviations. The voluntary recall affects 10,752 bottles distributed in Delaware.
RemedyRepack Inc. is recalling Clindamycin HCl 300 mg Capsules due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 1,858 30-count blister cards distributed in Pennsylvania.
Pharmadel, LLC is recalling DoloEar Homeopathic Earache Drops (0.50 oz, 15 mL) due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 27,648 bottles distributed in Delaware.
Apipharma is voluntarily recalling Kapsin Ointment (Camphor 3.16% and Capsaicin 0.03%) distributed in Arizona due to Current Good Manufacturing Practice (CGMP) deviations.
Pharmadel, LLC is recalling Rapidol Arnica Gel (2 oz, 57 g) distributed in Delaware due to manufacturing process deviations. The voluntary recall affects 6,048 bottles of lot EAG-01 with expiration date MAR 27.
Dr. Reddy's Laboratories is recalling Levetiracetam 0.75% Sodium Chloride Injection due to a labeling discrepancy where the infusion bag is incorrectly labeled as 0.82% Sodium Chloride 500 mg/100 mL instead of the correct 0.75% Sodium Chloride 1,000 mg/100 mL.
Eugia US LLC is recalling Testosterone Cypionate Injection due to complaints that crystals do not redissolve into solution after warming and shaking. The defect may affect product safety and efficacy.
Chattem Inc. is recalling Unisom SleepMinis 25 mg diphenhydramine capsules due to detection of nitrosamine impurity above FDA limits. Affected lots are 22L603 (exp. Oct 2025) and 378999 (exp. Feb 2027).
Direct Rx is recalling Ciprofloxacin Ophthalmic Solution 0.3% because the cap spike may lodge in the bottle nozzle, preventing the medication from being dispensed.
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