Hetero Labs Limited (Unit V) recalls Pantoprazole Sodium
- Recalling company
- Hetero Labs Limited (Unit V)
- Product
- Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10
- Reason
- Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 26, 2026
- Reported
- Apr 29, 2026
- Distribution
- Nationwide in the USA.
- Status
- Ongoing
- Quantity
- 4,740 1,000-count bottles.
- Lot / codes
- Batch # FD253967, Exp Date: 06/26/2027
- Company location
- Mahabubnagar, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0484-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0484-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.