FDA Drug Recalls

4 recalls · Class III, newest first

Apr 15, 2025 Class III · Low risk

Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..

Terminated Wrong potency / content OurPharma LLC NDC 73013-1040-01 D-0385-2025

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

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 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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