Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceu
Summary
The FDA issued a Class II for Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx by Hetero Labs Limited (Unit V). Reason: Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots.".
Details
Source
Drug Recall
External ID
D-0484-2026
Action Date
2026-04-29
Status
Ongoing
Category
drug
Product Description
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10
Lot/Code Info: Batch # FD253967, Exp Date: 06/26/2027
Quantity Affected: 4,740 1,000-count bottles.
Reason for Recall
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-26
Company
Mahabubnagar, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 82 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hetero Labs Limited (Unit V)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hetero Labs Limited (Unit V) have FDA actions?
This is the only FDA action we have on record for Hetero Labs Limited (Unit V) in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0484-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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