Class II · Moderate risk
Carbamazepine Tablets
CGMP deviations: tablets with black specks.
Carbamazepine Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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.
Affected NDC
51672-4005-03
Compare with the code on your package — it is the most precise check available.
Drug: Carbamazepine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Carbamazepine NDC 51672-4005 |
200 mg/1 | Tablet Oral |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 51672-4005-3
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0770-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Carbamazepine recalls
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Class II · Moderate risk
Carbamazepine Extended-Release Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Carbamazepine Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Carbamazepine 200mg Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Carbamazepine 200 mg Tablets
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Other recalls by Sun Pharmaceutical Industries INC
All 2026 recalls
Unclassified
Nystatin Cream
Failed Stability Specifications
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Budesonide Inhalation Suspension
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
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