Recall
FDAHealthMarch 26, 2026

Hetero Labs Limited (Unit V) — Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, H

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 26, 2026

Nationwide in the USA.

What's affected?

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
UPC
0331722713900
Lot code
Batch # FD253967, Exp Date: 06/26/2027

Additional details

Batch # FD253967, Exp Date: 06/26/2027

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 4,740 1,000-count bottles..

View original FDA notice →

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