FDA DrugsClass II
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx ...
Published: April 29, 2026Recall ID: D-0484-2026Category: drugsCountry: US
Reason for Recall / Hazard
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Mahabubnagar |
| State | N/A |
| Openfda › Upc › 1 | 0331722713900 |
| Openfda › Upc › 2 | 0331722712903 |
| Openfda › Unii | 6871619Q5X |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 251872 |
| Openfda › Rxcui › 2 | 314200 |
| Openfda › Spl id | 48f42a12-2eac-e5dd-e063-6294a90aa92d |
| Openfda › Brand name | PANTOPRAZOLE SODIUM |
| Openfda › Spl set id | 9daa1483-5a36-44db-9e0d-904d100da262 |
| Openfda › Package ndc › 1 | 31722-712-90 |
| Openfda › Package ndc › 2 | 31722-712-32 |
| Openfda › Package ndc › 3 | 31722-712-31 |
| Openfda › Package ndc › 4 | 31722-713-90 |
| Openfda › Package ndc › 5 | 31722-713-32 |
| Openfda › Package ndc › 6 | 31722-713-31 |
| Openfda › Package ndc › 7 | 31722-713-10 |
| Openfda › Product ndc › 1 | 31722-712 |
| Openfda › Product ndc › 2 | 31722-713 |
| Openfda › Generic name | PANTOPRAZOLE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | PANTOPRAZOLE SODIUM |
| Openfda › Manufacturer name | Camber Pharmaceuticals, Inc. |
| Openfda › Application number | ANDA202882 |
| Openfda › Is original packager | true |
| Event id | 98671 |
| Address 1 | Unit V, Sy. No.: 439,440,441&458 |
| Address 2 | Tsiic Formulation Sez, Polepally Village |
| Code info | Batch # FD253967, Exp Date: 06/26/2027 |
| Postal code | N/A |
| Report date | 20260429 |
| Product type | Drugs |
| Product 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." |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260326 |
| Initial firm notification | N/A |
| Center classification date | 20260417 |
Overview
- Recalling FirmHetero Labs Limited (Unit V)
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA.