CLASS II ONGOING Drug recall · Reported 26 Aug 2026 · FDA Enforcement Report
Carbamazepine Tablets, USP, 200mg recalled
SUN Pharmaceutical Industries is recalling Carbamazepine Tablets, USP, 200mg, distributed nationwide in the US. The recall was initiated on 3 Aug 2026 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-0770-2026
- FDA event ID
- 99562
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Aug 2026
- FDA classified
- 18 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Seizure Medication
Timeline
| 3 Aug 2026 | Recall initiated by company | |
| 18 Aug 2026 | Classified by FDA | +15 days |
| 26 Aug 2026 | Published in enforcement report | +8 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; black spots found on tablets from burnt excipient during manufacturing
Product as listed by the FDA
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.
Where it was distributed
US Nationwide.
Questions about this recall
Is Carbamazepine Tablets, USP, 200mg recalled?
Yes. SUN Pharmaceutical Industries recalled Carbamazepine Tablets, USP, 200mg on 3 Aug 2026. The recall is Class II and its status is Ongoing. Recall number D-0770-2026.
Why was it recalled?
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Which lots are affected?
Lot # AD94033, Exp Date: 5/31/2028.
Where was it sold?
US Nationwide.
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 22 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Carbamazepine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalledCarbamazepine | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbamazepine Extended-Release Tablets recalledCarbamazepine | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP 200 mg recalled by Torrent PharmaCarbamazepine | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine 200mg Tablets, USP, 200 mg Unit Dose recalledCarbamazepine | The Harvard Drug Group | Potency & Assay | NC |
| Drug | CLASS II | Carbamazepine Tablets, USP 200 mg recalled by Torrent PharmaCarbamazepine | Torrent Pharma | Potency & Assay | Nationwide |