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 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 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.
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.
Nephron is recalling 24,870 Phenylephrine HCl Injection vials nationwide due to lack of sterility assurance. No illnesses have been reported.
Accord Healthcare recalled 1.4 million bottles of Finasteride 1 mg tablets due to manufacturing quality deviations discovered during FDA inspection. No illnesses have been reported.
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.
Nephron Sterile Compounding Center is recalling Diltiazem HCl injectable due to lack of sterility assurance. The FDA Class II recall affects 4,743 bottles distributed nationwide.
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 is recalling Rosuvastatin 10 mg tablets due to manufacturing deviations identified during FDA inspection. No illnesses or injuries have been reported.
Accord Healthcare is recalling 10,992 bottles of Buspirone Hydrochloride 15 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing quality control deviations found during an FDA inspection.
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 recalls 31,116 bottles of Doxazosin Tablets USP 8 mg due to manufacturing practice deviations identified during FDA inspection. Distribution covered the US, Puerto Rico, and Canada.
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 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 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 821 cartons of Vigabatrin for Oral Solution due to manufacturing quality deviations found during an FDA inspection. The product was distributed in the United States, Puerto Rico, and Canada.
DuPont Nutrition USA is recalling BD-102 NF Microcrystalline Cellulose, a pharmaceutical excipient, due to failed conductivity specifications. Affected batches were distributed nationwide and internationally for use in drug manufacturing.
Accord Healthcare recalls 539,004 bottles of Aripiprazole 10 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing process deviations found during an FDA inspection.
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 Pirfenidone 801 mg tablets due to Current Good Manufacturing Practice deviations identified during an FDA inspection. Affected batches P2202519 and P2202513 were distributed in the United States, 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 is recalling 8,184 bottles of Ropinirole 4 mg tablets due to manufacturing practice deviations found during an FDA inspection. The recalled batches were distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling 25,344 bottles of Ropinirole 2 mg tablets due to manufacturing deviations discovered during an FDA inspection. The recall affects medications distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling Daptomycin for Injection due to manufacturing practice deviations discovered during FDA inspection. No illnesses or injuries have been reported.
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