FDA recall, , Moderate risk
Camber Pantoprazole Sodium Delayed-Release Tablets
Pantoprazole Sodium tablets are discolored with lighter-colored spots.
Summary by Recall Canary from the FDA notice
What happened
Hetero Labs Limited (Unit V) of Mahabubnagar, India, recalled Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottles, manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ. The FDA reported the recall began on March 26, 2026, and was added to the Enforcement Report on April 17, 2026. The firm received five complaints stating that tablets were discolored darker than normal and had lighter-colored spots. The product was distributed nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle
- NDC
- 31722-713-10
- Lot code
- FD253967
Recall details
- Company began the recall
- Sold in
Nationwide in the USA.
- Company
- Hetero Labs Limited (Unit V)Mahabubnagar, India
- Hazard
- Quality problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98671
- Recall number
- D-0484-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
