Elevated site urgencyFDA Class II

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Agency
FDA Drug
Recall date
Jul 8, 2026
Status
Ongoing
Company
Ascend Laboratories, LLC

1. What product was recalled?

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30

Quantity: 6,192 bottles

Code or lot text: Lot 25121311, expiry 3/31/2028

LOT
Lot 25121311
LOT
expiry 3/31/2028
NDC
67877-499
NDC
67877-499-30
NDC
67877-499-90
NDC
67877-500
NDC
67877-500-30
NDC
67877-500-90
NDC
67877-501
NDC
67877-501-30
NDC
67877-501-90
NDC
67877-502
NDC
67877-502-30
NDC
67877-502-90
RECALL-NUMBER
D-0712-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. unchanged
  2. created

10. Where is the official source?

Open the official FDA Drug source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.