Pantoprazole Sodium Tablet, Delayed Release
FDA Recall NDC 31722-712
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Pantoprazole Sodium (NDC 31722-712). A significant event, classified as Class II, was initiated on Mar 26, 2026 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots.""
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Mar 26, 2026
Apr 29, 2026
4,740 1,000-count bottles.
Recall Profile & Regulatory Data
Event ID
98671
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Hetero Labs Limited (Unit V)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
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
Batch or Lot Expiration Information
Batch# FD253967, Exp Date: 06/26/2027
Affected Packages Involved in this Recall
31722-712-90Product
31722-712-32Product
31722-712-31Product
31722-713-90Product
31722-713-32Product
31722-713-31Product
31722-713-10Product
Class II Ongoing
CGMP Deviations: Discoloration
Mar 14, 2023
Apr 19, 2023
2,352 bottles
Recall Profile & Regulatory Data
Event ID
91855
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Hetero USA Inc
Voluntary / Mandated
N/A
Distribution Pattern
Nationwide within the United States
Product Description
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10
Batch or Lot Expiration Information
Lot# : PAN22542, Exp. Date: 9/2024
Affected Packages Involved in this Recall
31722-712-90Product
31722-712-32Product
31722-712-31Product
31722-713-90Product
31722-713-32Product
31722-713-31Product
31722-713-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
