FDA DrugsClass II
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25...
Published: May 20, 2026Recall ID: D-0547-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Dissolution Specifications
Product Description & Identification
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.
Additional Source Details
| Field | Value |
|---|---|
| City | Bedminster |
| 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 | 7b6e362b-e8bc-45ee-b369-7109fb60adeb |
| Openfda › Brand name | METOPROLOL SUCCINATE |
| Openfda › Spl set id | 58441cd3-6043-4bb8-adab-1b32a203bfb2 |
| Openfda › Package ndc › 1 | 67877-590-30 |
| Openfda › Package ndc › 2 | 67877-590-60 |
| Openfda › Package ndc › 3 | 67877-590-01 |
| Openfda › Package ndc › 4 | 67877-590-05 |
| Openfda › Package ndc › 5 | 67877-590-10 |
| Openfda › Package ndc › 6 | 67877-591-30 |
| Openfda › Package ndc › 7 | 67877-591-60 |
| Openfda › Package ndc › 8 | 67877-591-01 |
| Openfda › Package ndc › 9 | 67877-591-05 |
| Openfda › Package ndc › 10 | 67877-591-10 |
| Openfda › Package ndc › 11 | 67877-592-30 |
| Openfda › Package ndc › 12 | 67877-592-60 |
| Openfda › Package ndc › 13 | 67877-592-01 |
| Openfda › Package ndc › 14 | 67877-592-05 |
| Openfda › Package ndc › 15 | 67877-592-10 |
| Openfda › Package ndc › 16 | 67877-593-30 |
| Openfda › Package ndc › 17 | 67877-593-60 |
| Openfda › Package ndc › 18 | 67877-593-01 |
| Openfda › Package ndc › 19 | 67877-593-05 |
| Openfda › Package ndc › 20 | 67877-593-10 |
| Openfda › Product ndc › 1 | 67877-590 |
| Openfda › Product ndc › 2 | 67877-591 |
| Openfda › Product ndc › 3 | 67877-592 |
| Openfda › Product ndc › 4 | 67877-593 |
| Openfda › Generic name | METOPROLOL SUCCINATE ER TABLETS |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | METOPROLOL SUCCINATE |
| Openfda › Manufacturer name | Ascend Laboratories, LLC |
| Openfda › Application number | ANDA211143 |
| Openfda › Is original packager | true |
| Event id | 98821 |
| Address 1 | 135 Us Highway 202 206 Ste 15 |
| Code info | Lot # 25140859; Exp. Date: Jan 2027 |
| Postal code | 07921-2608 |
| Report date | 20260520 |
| Product type | Drugs |
| Product quantity | 17,304 100-count bottles |
| Reason for recall | Failed Dissolution Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260427 |
| Initial firm notification | Letter |
| Center classification date | 20260520 |
Overview
- Recalling FirmAscend Laboratories, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide