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.
Accord Healthcare is recalling 747,464 bottles of Aripiprazole 2mg tablets due to manufacturing process deviations discovered during an FDA inspection. The affected medication was distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling 170,448 bottles of Aripiprazole 20 mg tablets distributed in the United States, Puerto Rico, and Canada due to manufacturing quality control (CGMP) deviations identified during FDA inspection.
Accord Healthcare is recalling Ropinirole 1 mg tablets due to manufacturing deviations identified during FDA inspection. No illnesses have been reported.
Nephron Sterile Compounding Center is recalling Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance. The recall affects 305,895 bottles across 13 lots.
Nephron Sc Inc recalls 325,080 vials of Sterile Water for Injection due to manufacturing quality deviations that could result in product carryover. Affected lots expire December 31, 2023.
FDA recalls norepinephrine bitartrate injection (270,291 bottles nationwide) due to lack of sterility assurance. The injectable medication from Nephron Sterile Compounding Center poses infection risk if used.
Accord Healthcare is recalling 113,571 bottles of dofetilide capsules distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection. No illnesses have been reported.
Nephron is recalling 24,870 Phenylephrine HCl Injection vials nationwide due to lack of sterility assurance. No illnesses have been reported.
Accord Healthcare is recalling Pravastatin Sodium 20 mg tablets following an FDA inspection that identified manufacturing practice deviations. Approximately 32,688 bottles were distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing practice deviations discovered during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.
Nephron Sterile Compounding Center is recalling Phenylephrine HCl injection nationwide due to lack of assurance of sterility. Lot PS2008A with expiration 03/07/2023 is affected.
Accord Healthcare recalls Glycopyrrolate Injection USP following FDA inspection identifying manufacturing deviations. Approximately 23,814 vials distributed to the US, Puerto Rico, and Canada are affected.
Accord Healthcare is recalling Pravastatin Sodium Tablets USP 40 mg due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 120 bottles distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare's Tadalafil 5 mg tablets are being recalled due to deviations from current good manufacturing practices identified during an FDA inspection. Approximately 1,113,264 bottles were distributed across the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling Simvastatin 5 mg tablets distributed in the United States, Puerto Rico, and Canada. The recall follows an FDA inspection that identified manufacturing practice deviations.
Accord Healthcare is recalling Ropinirole 5mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recall affects 5,112 bottles distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling 44,068 bottles of Doxazosin 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations found during an FDA inspection.
Accord Healthcare is recalling Rosuvastatin tablets 5mg due to manufacturing practice deviations found during an FDA inspection. The recall involves 63,247 bottles distributed across the U.S., Puerto Rico, and Canada.
Accord Healthcare recalls Glycopyrrolate injection due to manufacturing practice deviations found during FDA inspection. The recall affects 3,164 vials distributed in the US, Puerto Rico, and Canada.
Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing compliance deviations identified during FDA inspection. The recall affects approximately 113,003 bottles distributed in the U.S., Puerto Rico, and Canada.
Accord Healthcare is recalling Finasteride 5 mg tablets due to manufacturing process deviations discovered during FDA inspection. Over 2.7 million bottles distributed in the US, Puerto Rico, and Canada are affected.
Accord Healthcare recalls Daptomycin for Injection in the US, Puerto Rico, and Canada affecting 65,233 vials due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection.
Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing deviations found during an FDA inspection. The recall involves 37,790 bottles distributed across the United States, Puerto Rico, and Canada.
SCA Pharmaceuticals is recalling 2,125 fentanyl injection syringes nationwide due to subpotency—the product contains less active ingredient than labeled. The firm voluntarily initiated this Class III recall in February 2023.
Accord Healthcare recalls Pirfenidone tablets due to manufacturing practice deviations found during FDA inspection. The recall affects 2,614 cartons distributed in the US, Puerto Rico, and Canada.
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