FDA Drug Recalls

57 recalls · Class III, newest first

Mar 4, 2025 Class III · Low risk

Cross Contamination

Ongoing Cross-contamination Sun Pharmaceutical Industries INC NDC 62756-138-05 D-0311-2025

Mar 4, 2025 Class III · Low risk

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

Terminated Dissolution failure The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-6592-04 D-0304-2025

Feb 24, 2025 Class III · Low risk

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.

Ongoing Wrong potency / content Imprimis NJOF, LLC D-0305-2025

Feb 24, 2025 Class III · Low risk

Presence of foreign tablets/capsules

Completed Particulate / foreign matter Kowa Pharmaceuticals America NDC 66869-404-90 D-0258-2025

Jan 17, 2025 Class III · Low risk

Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.

Terminated Labeling / mix-up The W.S. Badger Company, Inc. D-0209-2025

Jan 16, 2025 Class III · Low risk

Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet

Completed Failed specification Appco Pharma LLC NDC 43598-943-90 D-0208-2025

Jan 7, 2025 Class III · Low risk

Superpotent; sodium benzoate preservative

Terminated Wrong potency / content PAI Holdings, LLC. dba Pharmaceutical Associates Inc NDC 0121-0775-16 D-0222-2025

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