Jubilant Cadista Recalls Pantoprazole Sodium Tablets Due to CGMP Deviations
Jubilant Cadista Pharmaceuticals is recalling 89,376 bottles of Pantoprazole Sodium Delayed-Release Tablets due to dark brown discoloration on 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 a visual discoloration (CGMP deviation) without reported injuries or illnesses, fitting the Moderate severity criteria for minor quality deviations.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling 89,376 90-count bottles of Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg. The product is distributed nationwide in the USA. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of dark brown discoloration on the edges of the tablets.
The affected product is identified by NDC 59746-284-90 and includes the following lot numbers and expiration dates: Lot # PA218005A (exp. 12/2020), PA218P010 and PA218P011 (exp. 04/2021), and PA218108A and PA218110A (exp. 06/2021). The tablets are manufactured by Jubilant Generics Ltd in Roorkee, India.
Consumers should check their medication for the specific NDC and lot numbers listed above. If the product matches the recalled items, they should contact their healthcare provider or pharmacist for guidance on disposal or replacement.
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, NDC 59746-284-90
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
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 (8)
- Lot # PA218005A
- exp. date 12/2020
- PA218P010
- PA218P011
- exp. date 04/2021
- PA218108A
- PA218110A
- exp. date 06/2021
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 · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- ModerateSildenafil Citrate Recall Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- HighShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19