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.
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, 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.
Related recalls
Same manufacturer · Jubilant Cadista Pharmaceuticals, Inc.
See all →- Moderate
- HighIrbesartan Blood Pressure Tablets Recalled Due to Failed Dissolution
FDA (Drugs) · 2022-08-03
- HighJubilant Cadista Irbesartan tablets recalled due to failed dissolution
FDA (Drugs) · 2022-08-03
- ModerateFDA Voluntary Recall of Methylprednisolone Tablets for Subpotency
FDA (Drugs) · 2022-04-13
- SevereMeclizine Hydrochloride Tablets Recalled Due to Incorrect Label Mix-up
FDA (Drugs) · 2022-04-06
Same hazard · discoloration
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateFresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
Similar recalls
- ModerateJubilant Cadista Recalls Pantoprazole Tablets Due to Dark Discoloration
FDA (Drugs) · 2018-10-17
- ModerateJubilant Cadista Recalls Pantoprazole Sodium Tablets Due to Discoloration
FDA (Drugs) · 2019-10-23
- ModerateJubilant Cadista Recalls Pantoprazole Sodium Tablets Due to CGMP Deviations
FDA (Drugs) · 2020-03-25
- ModerateJubilant Cadista Recalls Pantoprazole Sodium Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2013-05-08
- ModerateJubilant Cadista Recalls Bupropion Hydrochloride Tablets Due to Impurities
FDA (Drugs) · 2017-04-19
- ModeratePantoprazole Sodium Tablets Recalled for Discoloration Issues
FDA (Drugs) · 2026-04-29