Recalls / Active ingredient / Phenylephrine Hydrochloride

Phenylephrine Hydrochloride

11 FDA drug recalls involving the active ingredient “Phenylephrine Hydrochloride” — 2 Class I.

Date	Class	Product	Firm
2023-04-20	Class I	G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expector	Novis PR, LLC dba Kramer Novis
2022-10-11	Class III	NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ CO	LNK International, Inc.
2021-08-24	Class II	Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laborat	Efficient Laboratories, Inc.
2021-08-24	Class II	Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratorie	Efficient Laboratories, Inc.
2021-03-15	Class II	NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: La	Cardinal Health Inc.
2021-03-11	Class II	Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vi	Sagent Pharmaceuticals Inc
2020-03-16	Class II	Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief	Glaxosmithkline Consumer Healthcare Holdings
2019-06-21	Class II	GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL	Pharma-Natural Inc.
2015-04-15	Class I	Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextrom	Reckitt Benckiser LLC
2013-06-18	Class II	Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine h	Novartis Consumer Health
2013-03-07	Class III	4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bo	Novartis Consumer Health