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.
Talon Compounding Pharmacy is recalling IC B Complex Injectable due to lack of assurance of sterility. The affected vial lot 09152021:12 was distributed across the United States, Washington, D.C., and Puerto Rico.
NOW Health Group Inc. is recalling NOW Ginseng & Royal Jelly 90 VCAPS and MMA Nutrition Ginselin 90 Veg Capsules because the products may contain Metronidazole, an undeclared pharmaceutical ingredient.
Golden State Medical Supply Inc. is recalling specific lots of Ezetimibe and Simvastatin 10 mg/40 mg tablets because an excipient used in manufacturing failed to meet conductivity specifications, and some bottles were found to contain foreign tablets.
Golden State Medical Supply Inc. is recalling Ezetimibe and Simvastatin 10 mg/80 mg tablets because the product was manufactured using an excipient that failed conductivity specifications.
Precision Dose Inc. is recalling Acetaminophen Oral Suspension (325 mg/10.15 mL) due to contaminated raw ingredient used in manufacturing. The recall affects 151,100 unit dose cups distributed nationwide for hospital use.
Sun Pharmaceutical Industries is recalling Tadalafil 5 mg tablets (Lot # DNC1127A) because an incorrect grade of Crospovidone was used during manufacturing. The product was distributed to one distributor who may have further distributed it nationwide.
Sun Pharmaceutical is recalling Tadalafil Tablets USP 20 mg due to use of an incorrect grade of Crospovidone during manufacturing. The recall affects 36,786 bottles distributed to one distributor.
Ascend Laboratories LLC is recalling Cefixime Capsules 400 mg nationwide due to failed impurities and degradation specifications. The affected lot is Lot 20140282 with an expiration date of December 2021.
Precision Dose Inc. is recalling 166,920 unit dose cups of Acetaminophen Oral Suspension 160 mg/5 mL (Lot 503670) distributed nationwide due to cGMP deviations involving contaminated raw ingredient used in manufacturing.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 40 INJ injectable vials due to lack of assurance of sterility.
A-S Medication Solutions LLC is recalling Cetirizine hydrochloride 10 mg tablets due to a labeling error: bottles were labeled as 90-count when they actually contain 30 tablets.
Bryant Ranch Prepack is recalling Methocarbamol 500mg tablets nationwide because the bottles are mislabeled—they actually contain 750mg tablets. The affected lot was distributed in 30-, 60-, and 90-count bottles.
Merck Sharp & Dohme Corp. is recalling Cubicin (daptomycin for injection) 500 mg vials due to the presence of glass particles. The recall affects a single lot distributed nationwide.
Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets 150/12.5 mg due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient, which resulted from CGMP deviations.
Lupin Pharmaceuticals is recalling Irbesartan tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects 30-count and 90-count bottles distributed nationwide.
Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets USP (300/12.5 mg) in 30-count and 90-count bottles due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient.
Lupin Pharmaceuticals is recalling Irbesartan 75 mg tablets due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient. The recall affects 51,144 bottles distributed nationwide.
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin Tablets (10 mg/80 mg) because the product was manufactured using an excipient that failed to meet conductivity specifications.
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin 10 mg/10 mg tablets nationwide because the product was manufactured using an excipient that failed to meet conductivity specifications.
Lupin Pharmaceuticals is recalling Irbesartan 300 mg tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects approximately 119,544 bottles distributed nationally.
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin 10 mg/40 mg tablets because an excipient used in manufacturing failed conductivity specifications. The recall affects 11,590 bottles of 30-count and 3,585 bottles of 90-count packages distributed nationwide.
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin Tablets (10 mg/20 mg) nationwide because the product was manufactured using an excipient that failed conductivity specifications.
Dr. Reddy's Laboratories is recalling 696 bottles of Ezetimibe and Simvastatin Tablets (10 mg/40 mg) distributed nationwide due to failed excipient specifications and the presence of foreign tablets in bottles.
Red Mountain Compounding Pharmacy is recalling Progesterone 100mg/ml MDV Oil Injection due to lack of assurance of sterility following FDA inspection. About 494 patients in seven states received prescriptions for this affected product.
Red Mountain Compounding Pharmacy is recalling Levocarnitine 100mg/mL solution for injection because FDA inspection found concerns about the product's sterility assurance. The product was distributed to patients in seven states.
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