Jubilant Cadista Recalls Pantoprazole Sodium Tablets Due to Discoloration
Jubilant Cadista Pharmaceuticals is recalling 12,960 bottles of Pantoprazole Sodium Delayed-Release Tablets due to dark brown discoloration on the tablet edges.
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 recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific defect is discoloration, which is a quality issue rather than a direct acute hazard like contamination or mislabeling of a critical allergen.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling 12,960 bottles of Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg. The recall is an expansion of an earlier recall initiated due to the presence of dark brown discoloration on the edges of the tablets.
The affected product is identified by Lot # PA217060A and has an expiration date of 05/2020. The product was distributed nationwide in the USA. The tablets are manufactured by Jubilant Generics Ltd. in India and marketed by Jubilant Cadista Pharmaceuticals Inc. in Salisbury, MD.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication.
The recalled product
- Product
- Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 12,960
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)
- Lot #: PA217060A
- Exp 05/2020
Distribution
Distributed nationwide across the United States.
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