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
- Brand
- PANTOPRAZOLE SODIUM
- 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..
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