D-0484-2026 Class II Ongoing

Recalled by Hetero Labs Limited (Unit V) — Mahabubnagar, N/A

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