Drug FDA Class II Ongoing Quality
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
Hetero Labs Limited (Unit V) Published Apr 29, 2026
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Hetero Labs Limited (Unit V) or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Affected products (1)
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
PANTOPRAZOLE SODIUM · 4,740 1,000-count bottles.
NDC: 31722-712, 31722-713, 31722-712-90, 31722-712-32, 31722-712-31, 31722-713-90, 31722-713-32, 31722-713-31, 31722-713-10
Code info: Batch # FD253967, Exp Date: 06/26/2027
Affected areas
Nationwide
Timeline
- InitiatedMar 26, 2026
- PublishedApr 29, 2026
- Recall number
- D-0484-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.