FDA DrugsClass II
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: ...
Published: March 11, 2026Recall ID: D-0354-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Dissolution Specifications
Product Description & Identification
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
Additional Source Details
| Field | Value |
|---|---|
| City | Parsippany |
| State | NJ |
| Openfda › Unii | TH25PD4CCB |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 866412 |
| Openfda › Rxcui › 2 | 866419 |
| Openfda › Rxcui › 3 | 866427 |
| Openfda › Rxcui › 4 | 866436 |
| Openfda › Spl id | e51ef0b9-fe4a-473c-92a0-6043fdb0b620 |
| Openfda › Brand name | METOPROLOL SUCCINATE |
| Openfda › Spl set id | b798601e-a369-4c8b-8235-08900e1b751d |
| Openfda › Package ndc › 1 | 45963-709-11 |
| Openfda › Package ndc › 2 | 45963-709-96 |
| Openfda › Package ndc › 3 | 45963-676-11 |
| Openfda › Package ndc › 4 | 45963-676-96 |
| Openfda › Package ndc › 5 | 45963-677-11 |
| Openfda › Package ndc › 6 | 45963-677-96 |
| Openfda › Package ndc › 7 | 45963-678-11 |
| Openfda › Product ndc › 1 | 45963-676 |
| Openfda › Product ndc › 2 | 45963-709 |
| Openfda › Product ndc › 3 | 45963-677 |
| Openfda › Product ndc › 4 | 45963-678 |
| Openfda › Generic name | METOPROLOL SUCCINATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | METOPROLOL SUCCINATE |
| Openfda › Manufacturer name | Actavis Pharma, Inc. |
| Openfda › Application number | ANDA204161 |
| Openfda › Is original packager | true |
| Event id | 98348 |
| Address 1 | 400 Interpace Pkwy Bldg A |
| Address 2 | N/A |
| Code info | Lot#: a) 0715J251, Exp.: 12/2026; 0716J251, Exp.: 01/2027; 0717J251, Exp.: 01/2027; b) 0715J252, Exp.: 12/2026; 0716J252, Exp.: 01/2027, 0717J252, Exp.: 01/2027. |
| Postal code | 07054-1120 |
| Report date | 20260311 |
| Product type | Drugs |
| Product quantity | 18,780 bottles |
| Reason for recall | Failed Dissolution Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260129 |
| Initial firm notification | Letter |
| Center classification date | 20260227 |
Overview
- Recalling FirmTeva Pharmaceuticals USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide