Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
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.
Accord Healthcare recalls Glimepiride 2 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. Approximately 992,622 bottles across multiple batches are affected.
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.
Accord Healthcare is recalling Doxazosin 2 mg tablets distributed across the United States, Puerto Rico, and Canada due to manufacturing practice deviations identified during an FDA inspection.
Accord Healthcare is recalling Simvastatin 10 mg tablets distributed in the U.S., Puerto Rico, and Canada due to manufacturing process deviations discovered during FDA inspection. Patients should contact their pharmacy or healthcare provider.
Accord Healthcare is recalling rosuvastatin 40 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing quality control deviations found during an FDA inspection. No illnesses have been reported.
Accord Healthcare is recalling Simvastatin 20 mg tablets due to manufacturing practice deviations discovered during an FDA inspection. The recall affects 1,394,208 bottles distributed in 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 Buspirone Hydrochloride 7.5 mg tablets (23,784 bottles) distributed in the US, Puerto Rico, and Canada due to manufacturing practice deviations identified during FDA inspection.
Accord Healthcare is recalling 24,408 bottles of Buspirone Hydrochloride tablets due to Current Good Manufacturing Practice deviations discovered during an FDA inspection.
Accord Healthcare is recalling Daptomycin for Injection due to manufacturing practice deviations discovered during FDA inspection. No illnesses or injuries have been reported.
Alvogen is recalling 21,276 bottles of Levothyroxine Sodium Tablets (Lot HE02221, expiration 05/2023) distributed nationwide and in Puerto Rico due to sub-potency.
Accord Healthcare is recalling Buspirone Hydrochloride tablets due to manufacturing process deviations found during an FDA inspection. The recall affects approximately 3,784 bottles distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling Aripiprazole 15 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during an FDA inspection.
Accord Healthcare is recalling Clopidogrel Tablets USP 75 mg due to manufacturing practice deviations found during an FDA inspection. Approximately 1.4 million bottles distributed across 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 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 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 recalls 181,848 bottles of Ropinirole 0.5 mg tablets distributed in the U.S., Canada, and Puerto Rico due to manufacturing practice deviations identified 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.
Snack Innovations Inc. is recalling Drizzilicious Mini Rice Cake bites for possible undeclared peanut residue. Consumers with peanut allergies should not consume the product.
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 recalls 325,356 bottles of Finasteride 1 mg tablets due to manufacturing practice deviations identified during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.
Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing deviations found during FDA inspection. No illnesses or injuries have been reported.
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.