FDA Drug Recalls

778 recalls, newest first

Class II · Moderate risk Ongoing Jan 8, 2025

babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658…

Reason Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was…

Johnson, S C and Son, Inc D-0298-2025

Class III · Low risk Terminated Jan 7, 2025

Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical…

Reason Superpotent; sodium benzoate preservative

PAI Holdings, LLC. dba Pharmaceutical Associates Inc NDC 0121-0775-16 D-0222-2025

Class II · Moderate risk Ongoing Jan 7, 2025

Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC…

Reason Presence of Foreign Tablets/Capsules

Amerisource Health Services LLC NDC 60687-423-11 D-0201-2025