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Class II · ModerateActive recall

Pantoprazole Sodium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch # FD253967, Exp Date: 06/26/2027
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCamber Pharmaceuticals, Inc.
Brand namePANTOPRAZOLE SODIUM
Generic namePANTOPRAZOLE
Active ingredient(s)PANTOPRAZOLE SODIUM
Distributed by / forCamber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India
NDC31722-713-10
Show the full FDA record
Full product labelPantoprazole 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
Recalling firmHetero Labs Limited (Unit V)
DistributionNationwide in the USA.
Quantity4,740 1,000-count bottles.
Recall initiated2026-03-26
Report date2026-04-29
Recall completed—
Recall numberD-0484-2026
ClassificationClass II
FDA statusOngoing
Origin on fileMahabubnagar N/A India

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.