FDA Drug Recalls

Recalls / Active ingredient / Dextromethorphan Hydrobromide

Dextromethorphan Hydrobromide

15 FDA drug recalls involving the active ingredient “Dextromethorphan Hydrobromide3 Class I.

DateClassProductFirm
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 DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58Efficient 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 Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient LaboratEfficient Laboratories, Inc.
2021-03-15Class IIBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML Cardinal Health Inc.
2021-03-15Class IINOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: LaCardinal Health Inc.
2021-03-15Class IINuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-6Cardinal Health Inc.
2020-06-16Class IIChildrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (eGlaxosmithkline Consumer Healthcare Holdings
2019-06-21Class IIGENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL Pharma-Natural Inc.
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.
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
2013-06-18Class IITheraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hNovartis Consumer Health