CLASS III Drug recall · Reported 1 Dec 2021 · FDA Enforcement Report
Topiramate Tablets, USP 50 mg recalled by Unichem Pharmaceuticals Usa
Unichem Pharmaceuticals USA is recalling Topiramate Tablets, USP 50 mg, distributed nationwide in the US. The recall was initiated on 25 Oct 2021 and the FDA has classified it as Class III.
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-0255-2022
- FDA event ID
- 88891
- Recalling firm
- Unichem Pharmaceuticals USA, East Brunswick, NJ
- Brand
- Topiramate
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Oct 2021
- FDA classified
- 19 Nov 2021
- Reported
- 1 Dec 2021
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Drug class
- Seizure Medication
Timeline
| 25 Oct 2021 | Recall initiated by company | |
| 19 Nov 2021 | Classified by FDA | +25 days |
| 1 Dec 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration
Product as listed by the FDA
Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Discoloration
Which lots are affected?
Lot #: ZTPM20044, Exp. Date 09/30/2022
Where was it sold?
Nationwide within the United States
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Unichem Pharmaceuticals USA
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | busPIRone Hydrochloride Tablets, USP, 5 mg recalledBuspirone Hydrochloride | Unichem Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Doxazosin Tablets, USP, 4 mg recalled by Unichem Pharmaceuticals USADoxazosin Mesylate | Unichem Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Bisoprolol Fumarate and Hydrochlorothiazide tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Unichem Pharmaceuticals USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS I | Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg recalledCyclobenzaprine Hydrochloride | Unichem Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS III | Clonidine Hydrochloride Tablets, USP, 0.3 mg recalledClonidine Hydrochloride | Unichem Pharmaceuticals USA | Packaging Defects | Nationwide |
Other Topiramate recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Trokendi XR, topiramate extended-release capsules, 25mg recalledTrokendi Xr | Supernus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Eprontia (topiramate) oral solution, 25 mg/mL recalledEprontia | Azurity Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Trokendi XR (topiramate) extended-release capsules 100 mg recalledTrokendi Xr | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Trokendi XR (topiramate) extended-release capsule, 50mg recalledTrokendi Xr | Supernus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Topiramate Tablets 200 mg recalled by Zydus Pharmaceuticals USATopiramate | Zydus Pharmaceuticals USA | Other | Nationwide |