PlainRecalls

Search Recalls

Search our full database of product recalls from FDA, CPSC, NHTSA, and USDA. Find recalls by product name, brand, manufacturer, hazard type, or keyword.

PlainRecalls indexes tens of thousands of recall records across multiple federal agencies. Use the search box below to find specific products or browse by agency, category, or date on the respective listing pages. Search results include the recall title, the recalling firm, severity classification, and the date the recall was announced.

Found 23 recalls matching "codeine"

FDA Drug Low Feb 12, 2025

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

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

FDA Drug Moderate Jun 7, 2023

Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operat…

Akorn, Inc.

FDA Drug Moderate Jun 7, 2023

Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 1…

Akorn, Inc.

FDA Drug Moderate Jun 7, 2023

Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031…

Akorn, Inc.

FDA Drug Moderate Sep 29, 2021

Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactu…

Morton Grove Pharmaceuticals, Inc.

FDA Drug Moderate Apr 22, 2020

Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c)…

H J Harkins Company Inc dba Pharma Pac

FDA Drug Moderate Apr 22, 2020

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08…

Aurobindo Pharma USA Inc.

FDA Drug Moderate Apr 22, 2020

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08…

Aurobindo Pharma USA Inc.

FDA Drug Moderate Apr 22, 2020

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08…

Aurobindo Pharma USA Inc.

FDA Drug Moderate Jun 19, 2019

Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongest…

Torrent Pharma Inc

FDA Drug Moderate Jun 19, 2019

Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Di…

Torrent Pharma Inc

FDA Drug Moderate Jun 19, 2019

Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16,…

Torrent Pharma Inc

FDA Food Moderate May 15, 2019

Frozen Poppy Seed Bread (57 grams), UPC Codes: (01)03556420003673(15)191122(10)181122(91)0937326, Lot 22112018

Laduree Usa

FDA Drug Moderate May 23, 2018

Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ…

Prescript Pharmaceuticals, Inc.

FDA Drug Moderate May 23, 2018

Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042.…

Prescript Pharmaceuticals, Inc.

FDA Drug Moderate Jan 17, 2018

Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76…

Woodfield Pharmaceutical, LLC

FDA Drug Low May 11, 2016

Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively …

A-S Medication Solutions LLC.

FDA Drug Low Apr 15, 2015

PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 m…

Qualitest Pharmaceuticals

FDA Drug Low Jan 14, 2015

ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-901…

Qualitest Pharmaceuticals

FDA Drug Low Jul 23, 2014

LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Onl…

Poly Pharmaceuticals, Inc

FDA Drug Low Jul 23, 2014

POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz.…

Poly Pharmaceuticals, Inc

FDA Drug Moderate Oct 31, 2012

Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** …

Mylan Pharmaceuticals Inc.

FDA Drug Low Oct 17, 2012

Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5m…

Actavis Mid Atlantic LLC

How PlainRecalls Search Works

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Information surfaced here is drawn from public sources, but individual records can contain clerical errors, may lag real-world changes, or may be incomplete for historical reasons. Before making any consequential decision — legal, medical, financial, employment, safety-related — you should verify the underlying fact directly with the issuing agency. PlainRecalls does not render professional advice, does not rank or endorse individual records, and does not accept paid placement. We surface public data faithfully and explain it in clear language; how you act on the information is your responsibility and, when the stakes are high, the responsibility of a licensed professional you consult.

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