The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0145-2020·Announced 2019-10-23

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.

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 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
Hazard
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

Distributed in 5 states:

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