Sun Pharmaceutical Industries recall: Carbamazepine Tablets
Sun Pharmaceutical Industries INC is recalling Carbamazepine Tablets because of manufacturing-practice violations – 1968 Bottles (1000Tablets/Bottle). The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on August 3, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Carbamazepine Tablets |
| Brand | Sun Pharmaceutical Industries |
| Company | Sun Pharmaceutical Industries INC |
| Type | Drugs |
| Classification | Class II |
| Recall date | August 3, 2026 |
| Published by FDA | August 26, 2026 |
| Quantity | 1968 Bottles (1000Tablets/Bottle) |
| Recall ID | 99562 |
Recalled products
- 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.
- FDA recall number
- D-0770-2026
- Codes, lots and dates
- Lot # AD94033, Exp Date: 5/31/2028.
- Quantity
- 1968 Bottles (1000Tablets/Bottle)
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99562
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Princeton, NJ, United States
Why it was recalled
The problem: manufacturing-practice violations.
The reason the FDA lists: “CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99562, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Sun Pharmaceutical Industries recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 23, 2026 |  Sun Pharmaceutical Industries recall: Nystatin CreamDrugs · N/A | Failed Stability Specifications Lower risk | FDA Not Yet Classified |
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Sun Pharmaceutical Industries Carbamazepine Tablets recalled?
Yes. Sun Pharmaceutical Industries INC recalled it on August 3, 2026; FDA published it August 26, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of manufacturing-practice violations. The reason given: CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.