Jubilant Cadista Recalls Pantoprazole Sodium Tablets Due to Discoloration
Jubilant Cadista Pharmaceuticals is recalling specific lots 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 involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The specific hazard is a cosmetic/quality defect (discoloration) without reported illness, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling 63,216 bottles of Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg. The affected product is packaged in 90-count bottles and is available by prescription only. The specific lots involved are PA218P008 and PA218P009, with an expiration date of 04/2021.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation involving the presence of dark brown discoloration on the edges of the tablets. This visual defect indicates a manufacturing quality issue rather than a confirmed contamination or active ingredient error.
The product was distributed to distributors and wholesalers in Mississippi, Ohio, Rhode Island, Tennessee, and Puerto Rico, who may have further distributed the product to the retail level. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 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
- Affected units
- 63,216
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 (3)
- Lot # PA218P008
- PA218P009
- Exp 04/2021
Distribution
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
- SevereShoolin Pharma Recalls Tadalafil USP 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