Carbamazepine Tablets recall
FDA recall D-0770-2026 · initiated Aug 3, 2026
SUN PHARMACEUTICAL INDUSTRIES INC recalled Carbamazepine Tablets in Aug 2026 — an FDA Class II recall (D-0770-2026) because CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1968 Bottles (1000Tablets/Bottle)
Details
- 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.
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Aug 3, 2026
- FDA report date
- Aug 26, 2026
Frequently asked
- Was Carbamazepine Tablets recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Carbamazepine Tablets in Aug 2026 — an FDA Class II recall (D-0770-2026) because CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Carbamazepine Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0770-2026 was: CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
- Is a recalled Carbamazepine Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Carbamazepine Tablets are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # AD94033, Exp Date: 5/31/2028.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0770-2026.