Class III · Low risk Terminated
Guaifenesin and Codeine Phosphate Oral Solution USP
Reason Superpotent; sodium benzoate preservative
Ephedrine 25 Guaifenesin 200 Tablet
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
What was recalled
Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
- Recalling firm
- ULTRAtab Laboratories, Inc.
- NDC code
- 62959-320-00
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0544-2022
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…
Reason CGMP Deviations: Released product should have been rejected.
Class II · Moderate risk Terminated
Guaifenesin Dextromethorphan Syrup
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Terminated
Guaifenesin Dextromethorphan Syrup
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Ongoing
Kids' Cough and Chest Congestion
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.