D-0484-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 29, 2026
- Initiation Date
- March 26, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,740 1,000-count bottles.
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
Reason for Recall
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Distribution Pattern
Nationwide in the USA.
Code Information
Batch # FD253967, Exp Date: 06/26/2027