Food, drugs, devices › Ascend Laboratories, LLC
Drug recall: Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd
FDA enforcement event 98874 is a drug recall by Ascend Laboratories, LLC of Bedminster, NJ, initiated 5 May 2026 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 74% of the 234 drug enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Ascend Laboratories, LLC has 36 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ascend Laboratories, LLC, Bedminster, NJ.
Reason for recall
"Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications"
Distribution
"U.S.A. Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0556-2026 | 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. | 15,696 x 30's bottles | Class II | Ongoing | 10 Jun 2026 |
Context
Other enforcement events for Ascend Laboratories, LLC
All 36 events for Ascend Laboratories, LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S.A. Nationwide"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.