Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1058-2020·Announced 2020-03-25

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.

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 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
Hazard: cgmp-deviation
visual-defect

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.

Same manufacturer · Jubilant Cadista Pharmaceuticals, Inc.

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Same hazard · cgmp deviation