Class III · Low risk Terminated
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical…
Reason Superpotent; sodium benzoate preservative
Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
What was recalled
Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OTC, Distributed by Reckitt Benckiser, Parsippany, NJ 07054-0224 Made in England
- Recalling firm
- Reckitt Benckiser LLC
- NDC code
- 63824-056-72
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0964-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Guaifenesin recalls
See all
Class II · Moderate risk Terminated
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10…
Reason CGMP Deviations: Released product should have been rejected.
Class II · Moderate risk Terminated
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN…
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Terminated
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN…
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Ongoing
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further…
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.