FDA Drug Recalls

Recalls / Active ingredient / Guaifenesin

Guaifenesin

13 FDA drug recalls involving the active ingredient “Guaifenesin3 Class I.

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
2023-04-20Class IG-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant ExpectorNovis PR, LLC dba Kramer Novis
2022-10-11Class IIINDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COLNK International, Inc.
2021-08-24Class IIRompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 Efficient Laboratories, Inc.
2021-08-24Class IIRompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient LaboratEfficient Laboratories, Inc.
2021-08-24Class IIRompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient LaboratorieEfficient Laboratories, Inc.
2021-08-24Class IIRompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58Efficient Laboratories, Inc.
2020-06-16Class IIChildrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (eGlaxosmithkline Consumer Healthcare Holdings
2019-06-21Class IISORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tspPharma-Natural Inc.
2019-05-28Class IPecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, AlcNovis PR, Inc.
2017-12-12Class IICodeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: MethoWoodfield Pharmaceutical, LLC
2015-04-15Class IMucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, DextromReckitt Benckiser LLC
2014-11-10Class IIIMucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets perReckitt Benckiser LLC