CLASS II Drug recall · Reported 16 Feb 2022 · FDA Enforcement Report
Ephedrine 25 Guaifenesin (Ephedrine HCl 25 mg recalled
ULTRAtab Laboratories is recalling Ephedrine 25 Guaifenesin (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container. The recall was initiated on 26 Jan 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0544-2022
- FDA event ID
- 89334
- Recalling firm
- ULTRAtab Laboratories, Highland, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jan 2022
- FDA classified
- 9 Feb 2022
- Reported
- 16 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Cold & Cough Medicine
Timeline
| 26 Jan 2022 | Recall initiated by company | |
| 9 Feb 2022 | Classified by FDA | +14 days |
| 16 Feb 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
Where it was distributed
Bulk product was distributed to 3 distributors who may have distributed finished product.
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Product Codes: M320L Bulk Lots: 18M063, 19G076
Where was it sold?
Bulk product was distributed to 3 distributors who may have distributed finished product.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
32 other products · FDA event 89334This product is part of a recall event; the main page for the event is APAP (Acetaminophen 500 mg) Bulk Container recalled.