UnratedDrug recall · FDA · Published August 3, 2026
Sun Pharmaceutical Carbamazepine Tablets Recall: Black Spots From Burnt Ingredients
Sun Pharmaceutical recalls 200mg Carbamazepine tablets with black spots caused by burnt excipients during manufacturing. Rx-only medication distributed by Taro Pharmaceuticals USA. No remedy specified in official notice.
“Sun Pharmaceutical Carbamazepine Tablets Recall: Black Spots From Burnt Ingredients.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/692871-sun-pharmaceutical-carbamazepine-tablets-recall-black-spots-from-burnt-ingredients. Based on FDA recall #D-0770-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0770-2026%22&limit=1).
The FDA announced on August 3, 2026, that Sun Pharmaceutical Industries Inc. is recalling Carbamazepine Tablets, USP, 200mg, due to CGMP deviations involving black spots on tablets. This voluntary Class II recall affects 1,968 bottles distributed nationwide.
How to tell if you have it
Brand: Sun Pharmaceutical Industries
Product: Carbamazepine Tablets, USP, 200mg
Packaging: 1000 count bottles
NDC: 51672-4005-3
Lot Code: AD94033
Expiration Date: 5/31/2028
Manufacturer: Taro Pharmaceutical Industries Ltd.
Distributor: Taro Pharmaceuticals USA, Inc.
The hazard
The recall addresses CGMP deviations where black spots were found on tablets caused by burnt excipient during manufacturing. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Sun Pharmaceutical Industries Inc. has 93 other recalls on record since May 21, 2013. Other recent recalls of similar products include Sun Pharmaceutical Nystatin Cream Recall (September 14, 2026), Sun Pharmaceutical Perampanel 6mg Tablets Recall (June 17, 2026), and Sun Pharmaceutical Fexofenadine 180mg Tablets Recall (June 1, 2026). Other recent recalls of similar products include Golden State Medical Supply recalls Carbamazepine 200mg tablets with black specks (August 7, 2026), Shoolin Pharma Chem Sildenafil Recall (August 3, 2026), and Macleods Olanzapine Tablets 5mg Recall (August 27, 2026).
How to tell if you have this one
Check for 200mg Carbamazepine tablets in 1000-count bottles with lot number AD94033. The product was distributed by Taro Pharmaceuticals USA and has an expiration date of May 31, 2028.
Brand
Sun Pharmaceutical Industries
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number AD94033 on the bottle to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 23 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0770-2026 (August 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0770-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.