Food, drugs, devices › Ascend Laboratories LLC
Drug recall: AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 4
Ascend Laboratories LLC (Montvale, NJ) initiated this drug recall on 5 May 2017; FDA lists 1 product record under event 77948, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 30% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 25 Apr 2018. 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, Montvale, NJ.
Reason for recall
"PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg."
Distribution
"Nationwide in the USA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1134-2017 | AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10 | 1212 bottles | Class III | Terminated | 20 Sep 2017 |
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: "PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 25 Apr 2018. "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.