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.
Med Shop Total Care Inc. is recalling a compounded injectable pain medication in Texas and Puerto Rico because the product failed to meet sterility standards. The recall affects lot 09292020@64.
Med Shop Total Care is recalling one lot of Fentanyl-Bupivacaine HCL PF Injectable due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.
Med Shop Total Care Inc. is recalling Hydromorphone HCL-Bupivacaine HCL PF Injectable in 21 and 22 mL syringes in various strengths distributed in Texas and Puerto Rico due to non-sterility concerns.
Med Shop Total Care Inc. is recalling Morphine-Bupivacaine-Ketamine PF Injectable syringes distributed in Texas and Puerto Rico due to non-sterility. The injectable comes in two strengths in 21 mL syringes and is available by prescription only.
Med Shop Total Care is recalling injectable syringes containing hydromorphone, bupivacaine, and fentanyl due to non-sterility concerns. The recall affects products distributed in Texas and Puerto Rico.
People's Custom Rx is recalling C-Progesterone Oil 100 mg/mL compounded vials due to non-sterility concerns. The recall affects 14 vials distributed in Mississippi and Tennessee.
Med Shop Total Care Inc. is recalling a 41 mL injectable drug combination due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.
Med Shop Total Care is voluntarily recalling injectable hydromorphone HCL-bupivacaine HCL-clonidine HCL due to non-sterility. The recall affects specific lots distributed in Texas and Puerto Rico.
Med Shop Total Care is recalling morphine-bupivacaine-fentanyl injectable syringes due to non-sterility. The affected lot was distributed in Texas and Puerto Rico.
Med Shop Total Care Inc. is recalling a bupivacaine HCL-baclofen PF injectable drug (21 mL syringe, Lot #: 09282020@94) distributed in Texas and Puerto Rico due to non-sterility concerns.
Eli Lilly is recalling 36,540 vials of Zyprexa (olanzapine) 10 mg intramuscular injection due to manufacturing deviations affecting the drug product's appearance, size, and color.
PAI Holdings is recalling Nystatin Oral Suspension nationwide due to a lack of Current Good Manufacturing Practice (CGMP) controls that could allow carryover of Senna Syrup into the product.
PAI Holdings is recalling Ethosuximide Oral Solution 250 mg/5 mL (Lot C9BC, expiration 31 October 2022) distributed nationwide due to potential carry-over contamination from Senna Syrup related to lack of current good manufacturing practices.
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Venlafaxine Tablets labeled as 50 mg because bottles contain Venlafaxine 37.5 mg tablets, creating a dosing error risk.
Pharmaceutical Associates Inc. is recalling Cimetidine Hydrochloride Oral Solution 300 mg/5 mL due to a lack of Current Good Manufacturing Practice (CGMP) and potential carryover of Senna Syrup.
Aurobindo Pharma USA Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) due to potential metal contamination in the product. The recall affects approximately 3,800 bottles distributed nationwide.
BayCare Central Pharmacy is recalling Succinylcholine Chloride 100 mg/5 mL syringes due to lack of sterility assurance. The affected lot was distributed in Florida.
Qikmoov LLC is recalling Vy&Tea herbal tea because FDA analysis detected sibutramine, an ingredient not approved in an NDA or ANDA application. The product was marketed and distributed nationwide and internationally.
Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with Moisturizer due to failure to meet the required denaturant specification. The product was distributed to affiliated facilities and third-party recipients in nine states.
Pfizer is recalling Chantix (varenicline tartrate) 1 mg tablets nationwide because certain lots contain the impurity N-nitroso-varenicline above FDA's acceptable interim intake limit due to manufacturing deviations.
Pfizer is recalling approximately 350,985 cartons of Chantix (varenicline tartrate) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects multiple lot numbers with expiration dates ranging from September 2021 to January 2023.
Pfizer is recalling Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects 59,232 bottles.
Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with moisturizer because the product does not meet the required denaturant specifications for alcohol-based antiseptics.
API Solutions Inc. is voluntarily recalling Azelaic Acid 99.0+% Micro 500 Grams (Lot #AZA181105, Exp 11/09/2021) distributed in five states due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.
API Solutions Inc. is recalling Estriol USP41 Micro 25 Grams (Lot #ETL181001) due to cGMP deviations. The product was distributed to AL, AZ, CO, FL, and VA.
Looking for a different category? Browse all recalls.