FDA Drug Recalls

Recalls / Active ingredient / Codeine Phosphate

Codeine Phosphate

6 FDA drug recalls involving the active ingredient “Codeine Phosphate.

DateClassProductFirm
2025-01-07Class IIIGuaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI PharPAI Holdings, LLC. dba Pharmaceutical Associates Inc
2020-03-18Class IIAcetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: AuAurobindo Pharma USA Inc.
2020-03-18Class IIAcetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: AuAurobindo Pharma USA Inc.
2020-03-18Class IIAcetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: AuAurobindo Pharma USA Inc.
2018-04-24Class IIAcetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for:Prescript Pharmaceuticals, Inc.
2017-12-12Class IICodeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: MethoWoodfield Pharmaceutical, LLC