FDA Recall D-0484-2026

Hetero Labs Limited (Unit V) · Mahabubnagar, N/A

Class II Ongoing 49 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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: Batch # FD253967, Exp Date: 06/26/2027

Quantity: 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."

Recall record

Recall number: D-0484-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Nationwide in the USA.
Recall initiated: 2026-03-26
Classified by FDA Center: 2026-04-17
FDA published: 2026-04-29
Recalling firm: Hetero Labs Limited (Unit V)
Firm location: Mahabubnagar, N/A, India

Drug identification

Brand name(s): PANTOPRAZOLE SODIUM
Generic name(s): PANTOPRAZOLE
Manufacturer(s): Camber Pharmaceuticals, Inc.
NDC(s): 31722-712, 31722-713
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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