FDA DrugsClass II
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle,...
Published: June 10, 2026Recall ID: D-0556-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Product Description & Identification
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
Additional Source Details
| Field | Value |
|---|---|
| City | Bedminster |
| State | NJ |
| Openfda › Unii › 1 | 6M97XTV3HD |
| Openfda › Unii › 2 | 864V2Q084H |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 730861 |
| Openfda › Rxcui › 2 | 730866 |
| Openfda › Rxcui › 3 | 730869 |
| Openfda › Rxcui › 4 | 730872 |
| Openfda › Spl id | 32238052-6c4c-4b29-a59e-524c819c69f1 |
| Openfda › Brand name | AMLODIPINE AND OLMESARTAN MEDOXOMIL |
| Openfda › Spl set id | c1204fbe-d086-43cf-bbaa-efec9cd0487c |
| Openfda › Package ndc › 1 | 67877-499-30 |
| Openfda › Package ndc › 2 | 67877-499-90 |
| Openfda › Package ndc › 3 | 67877-500-30 |
| Openfda › Package ndc › 4 | 67877-500-90 |
| Openfda › Package ndc › 5 | 67877-501-30 |
| Openfda › Package ndc › 6 | 67877-501-90 |
| Openfda › Package ndc › 7 | 67877-502-30 |
| Openfda › Package ndc › 8 | 67877-502-90 |
| Openfda › Product ndc › 1 | 67877-499 |
| Openfda › Product ndc › 2 | 67877-500 |
| Openfda › Product ndc › 3 | 67877-501 |
| Openfda › Product ndc › 4 | 67877-502 |
| Openfda › Generic name | AMLODIPINE AND OLMESARTAN MEDOXOMIL |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name › 1 | AMLODIPINE BESYLATE |
| Openfda › Substance name › 2 | OLMESARTAN MEDOXOMIL |
| Openfda › Manufacturer name | Ascend Laboratories, LLC |
| Openfda › Application number | ANDA209042 |
| Openfda › Is original packager | true |
| Event id | 98874 |
| Address 1 | 135 Us Highway 202 206 Ste 15 |
| Code info | Lot: 24123460, Expires: October 31, 2027. |
| Postal code | 07921-2608 |
| Report date | 20260610 |
| Product type | Drugs |
| Product quantity | 15,696 x 30's bottles |
| Reason for recall | Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260505 |
| Initial firm notification | Letter |
| Center classification date | 20260602 |
Overview
- Recalling FirmAscend Laboratories, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionU.S.A. Nationwide