FDA recall D-0484-2026

Hetero Labs Limited (Unit V) · Class II · drug

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 for recall

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

Distribution

Nationwide in the USA.

Key facts

Status
Ongoing
Initiation date
2026-03-26
Report date
2026-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahabubnagar, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0484-2026