HIGH

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,...

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

Quick Facts at a Glance

Recall Date
March 26, 2026
Hazard Level
HIGH
Brands
PANTOPRAZOLE SODIUM, Camber Pharmaceuticals, Inc.
Geographic Scope
1 states

Hazard Information

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Hetero Labs Limited (Unit V) or your healthcare provider for guidance. Notification method: N/A

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Full 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. Generic: PANTOPRAZOLE; Brand: PANTOPRAZOLE SODIUM. Reason: Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots.". Classification: Class II. Quantity: 4,740 1,000-count bottles.. Distribution: Nationwide in the USA.

Safety Guide

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Product Classification

Product Details

Model Numbers
Batch # FD253967
Exp Date: 06/26/2027
UPC Codes
31722-712
31722-713
31722-712-90
+6 more
Affected States
ALL
Report Date
April 29, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE