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.
IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution due to subpotency—some doses contain insufficient active ingredient. Patients should contact their pharmacist or doctor to verify their medication.
IBSA Pharma has recalled one lot of TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotency. The product contained less active ingredient than labeled.
IBSA PHARMA INC is recalling TIROSINT oral solution (Lot #220855) nationwide due to insufficient potency of levothyroxine sodium. The defective lot was voluntarily recalled after manufacturer discovery.
Amerisource Health Services is recalling Metoprolol Succinate Extended-Release Tablets due to failed dissolution specifications that may prevent proper drug release.
Sentara Infusion Services is recalling Vancomycin 700 MG and 1000 MG intravenous solution formulations due to lack of sterility assurance. Eighteen bags were distributed nationwide.
Sentara Infusion Services recalled 72 bags of ceftriaxone injectable antibiotic due to lack of sterility assurance. The affected product was distributed nationwide with a beyond-use date of December 24–31, 2022.
Sentara Infusion Services is recalling Ceftriaxone antibiotic infusions nationwide because the manufacturer cannot assure the products meet sterility standards. Patients should contact their healthcare provider.
Sentara Infusion Services is recalling Hydrocortisone sterile injection syringes nationwide due to lack of sterility assurance. Patients who received affected syringes should contact their physician immediately.
Sentara Infusion Services is recalling compounded Cefazolin/Heparin injectable syringes due to lack of sterility assurance. Eight syringes with a December 2022 beyond-use date are affected.
Sentara Infusion Services is recalling Piperacillin/Tazobactam antibiotic injections due to lack of sterility assurance. The 78-unit recall affects patients nationwide.
Sentara Infusion Services is recalling Diphenhydramine 18mg syringes distributed nationwide due to lack of sterility assurance. The 15-bag recall affects injectable antihistamine products that may pose an infection risk if used.
Sentara Infusion Services is recalling Morphine Sulfate intravenous infusion solutions (1 mg/mL and 5 mg/mL) distributed nationwide due to lack of sterility assurance. The products may not be sterile, creating a potential risk of infection.
Sentara Infusion Services is recalling 30 bags of Metronidazole 500mg injectable antibiotic distributed nationwide due to lack of sterility assurance. Patients using the product should contact their healthcare provider.
Sentara Infusion Services is recalling Sodium Chloride 0.9% solution dispensed to patients nationwide due to lack of sterility assurance. The product was used as a diluent in home infusion therapy with Curlin or Sapphire pumps.
Sentara Infusion Services is recalling 111 bags of TPN (Total Parenteral Nutrition) solution due to lack of sterility assurance. Products were dispensed nationwide to patients.
Sentara Infusion Services is recalling 31 nalbuphine syringes (1.5mg and 2.5mg) dispensed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.
McGuff Compounding Pharmacy recalls 255 vials of thiamine and riboflavin injection nationwide due to foreign substances found in some vials.
Sentara Infusion Services is recalling Dextrose 10% 720ML TPN injectable solutions nationwide due to lack of sterility assurance. Patients using this product should contact their healthcare provider.
Sentara Infusion Services is recalling 14 bags of Levaquin 750MG injectable antibiotic dispensed nationwide due to lack of sterility assurance. The product was distributed to patients for home infusion pump use.
A sterile injectable drug, Abelcet, is being recalled due to bacterial contamination detected in a nationwide shipment. The recall affects 31,879 vials with lot number 1203A.
Sentara Infusion Services is recalling Ampicillin/Sulbactam 3GM intravenous bags due to lack of sterility assurance. The affected product was dispensed nationwide to home infusion patients.
Sentara Infusion Services is recalling Ampicillin 12GM in NS 600M injectable solution due to lack of sterility assurance. The affected product was dispensed nationwide; patients should contact their healthcare provider.
Amerisource Health Services LLC is recalling 1,416 cartons of Bupropion Hydrochloride Tablets (75 mg) nationwide due to failed impurities and degradation specifications. The tablets do not meet FDA quality standards for purity.
Sentara Infusion Services is recalling 17 units of ETHANOL 70% 0.5ML syringes distributed nationwide due to lack of sterility assurance. The syringes may not meet required sterility standards for safe injection.
Sentara Infusion Services is recalling Pantoprazole 30mg intravenous syringes due to lack of sterility assurance. The product was dispensed to patients nationwide.
Looking for a different category? Browse all recalls.