Recalling firm
Hetero Labs Limited (Unit V)
Product type
Drug
Status
Ongoing
Report date
2026-04-29
Distribution
Nationwide in the USA.
Firm state
N/A
Product quantity
4,740 1,000-count bottles.
Initiated by
Voluntary: Firm initiated
Reason for recall
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
Code / lot info
Batch # FD253967, Exp Date: 06/26/2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.