Pantoprazole Sodium Tablets Recalled for Discoloration Issues
Hetero Labs Limited is recalling Pantoprazole Sodium 40 mg delayed-release tablets due to discoloration—some tablets are darker than normal with lighter-colored spots. The firm received five complaints about the affected tablets.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source is classified as FDA Class II but does not report any illnesses, hospitalizations, or injuries—only a cosmetic discoloration issue (darker tablets with lighter spots) based on five complaints. The hazard is visual/appearance-based with no documented adverse health consequences, placing this in the Moderate category per the rubric for Class II recalls without reported harm.
Plain-English summary
Hetero Labs Limited (Unit V) is recalling Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg tablets distributed nationwide in the USA. The recall involves batch #FD253967 (expiration date 06/26/2027), comprising 4,740 bottles of 1,000-count tablets manufactured for Camber Pharmaceuticals, Inc.
The firm received five complaints reporting that tablets in the affected batch were discolored darker than normal and had lighter-colored spots. This visual discoloration is the basis for the recall.
Patients currently taking this medication from the affected batch should contact their pharmacist or healthcare provider. Consumers with the affected product should not take the tablets and should return them to their pharmacy or the manufacturer.
This is a Class II FDA recall. Additional information is available from the FDA at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls under recall number D-0484-2026.
The recalled product
- Product
- PANTOPRAZOLE SODIUM (PANTOPRAZOLE)
- Brand
- PANTOPRAZOLE SODIUM
- Manufacturer
- Hetero Labs Limited (Unit V)
- Hazard
- discoloration
- appearance-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # FD253967
- Exp Date: 06/26/2027
UPCs (2)
- 0331722713900
- 0331722712903
Distribution
Distributed nationwide across the United States.