Jubilant Cadista Recalls Pantoprazole Tablets Due to Dark Discoloration
Jubilant Cadista Pharmaceuticals is recalling 158,466 bottles of 40 mg pantoprazole sodium delayed-release tablets due to dark discoloration or brown spots on the edges.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the hazard is a cosmetic defect (discoloration) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling 158,466 bottles of Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90-count. The product is manufactured by Jubilant Generics Ltd. in India and marketed by Jubilant Cadista Pharmaceuticals in Salisbury, Maryland. The recall is classified as FDA Class II.
The reason for the recall is the presence of dark discoloration or brown spots on the edges of the tablets. The affected lots include PA26038A, PA26039A, PA26040A, PA26050A, PA26052A, PA26073A, PA217071A, PA217072A, PA217073B, PA217074B, PA217101A, and PA218023A, with expiration dates ranging from April 2019 to January 2021.
The product was distributed nationwide in the USA and Puerto Rico. Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the tablets exhibit dark discoloration or brown spots on the edges, they should stop using the product and contact their healthcare provider or pharmacist for guidance.
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
- 158,466
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 (19)
- Lot #: PA26038A
- Exp 04/19
- PA26039A
- PA26040A
- PA26050A
- Exp 05/19
- PA26052A
- Exp 06/19
- PA26073A
- Exp 07/19
- PA217071A
- PA217072A
- PA217073B
- PA217074B
- Exp 06/20
- PA217101A
- Exp 08/20
- and PA218023A
- Exp 01/21.
Distribution
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