Why it was recalled
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Product description
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
Lot numbers, UPCs & expiration codes
Batch # FD253967, Exp Date: 06/26/2027
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0484-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 26, 2026
- FDA report date
- Apr 29, 2026
- Quantity
- 4,740 1,000-count bottles.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero Labs Limited (Unit V)
Original FDA data
Every field from FDA enforcement report D-0484-2026, exactly as published.
Show all FDA fields
- City
- Mahabubnagar
- Status
- Ongoing
- Country
- India
- Event ID
- 98671
- Address
- Unit V, Sy. No.: 439,440,441&458
- Address (line 2)
- Tsiic Formulation Sez, Polepally Village
- Code information
- Batch # FD253967, Exp Date: 06/26/2027
- Report date
- Apr 29, 2026
- Product type
- Drugs
- Recall number
- D-0484-2026
- Classification
- Class II
- Recalling firm
- Hetero Labs Limited (Unit V)
- Product quantity
- 4,740 1,000-count bottles.
- Reason for recall
- Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 26, 2026
- Center classification date
- Apr 17, 2026