SUN PHARMACEUTICAL INDUSTRIES INC Carbamazepine Tablets, USP, 200 mg Recall
Announced 2026-08-26 · FDA
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Carbamazepine Tablets, USP, 200 mg, Rx only, due to CGMP deviations and black spots found on tablets from burnt excipient during manufacturing. The recall involves 1,968 bottles distributed nationwide in the United States, Lot AD94033, expiration date 5/31/2028.
| Brand | SUN PHARMACEUTICAL INDUSTRIES INC |
|---|---|
| Product | 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. |
| Reason | CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing |
| Severity | moderate |
| Units affected | 1968 |
| Distribution | US Nationwide. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not take any Carbamazepine tablets from Lot AD94033. If you have this lot, stop using it.
- Consult your pharmacist or healthcare provider for advice and potential alternatives.
- Return the affected product per FDA recall instructions or contact SUN PHARMACEUTICALS for disposal/return instructions.
- If you experience adverse symptoms, contact your clinician.
How to identify the recalled item
| Lot / date codes | Lot # AD94033, Exp Date: 5/31/2028. |
|---|---|
| Lot / date codes | Lot # AD94033, Exp Date: 5/31/2028. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other SUN PHARMACEUTICAL INDUSTRIES INC recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.