Ascend Laboratories recalls amlodipine and olmesartan medoxomil tablets because they failed a dissolution test
The tablets failed dissolution specifications, and the olmesartan medoxomil content was below what it should be.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- 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.
- Company
- Ascend Laboratories, LLC
- Hazard
- Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
- Units
- 15,696 x 30's bottles
- Where sold
- U.S.A. Nationwide
- FDA classification
- Class II · Ongoing
- Classified by FDA
- June 2, 2026
- Recall started
- May 5, 2026
- FDA enforcement report
- June 10, 2026
- Identifiers
- Codes: Lot: 24123460, Expires: October 31, 2027.
- FDA recall number: D-0556-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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.
- Reason for recall
- Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
- Classification
- Class II (Ongoing)
- Distribution
- U.S.A. Nationwide
- Quantity
- 15,696 x 30's bottles
Related recalls
Ascend Laboratories recalls amlodipine and olmesartan medoxomil tablets because they failed a dissolution test
The 10mg/40mg tablets, sold in 30-tablet bottles, were found to be out of specification due to dissolution, and 11,424 bottles were distributed nationwide within the United States.
Ascend Laboratories, LLC · 11,424 bottles.
Ascend Laboratories recalls Dabigatran Etexilate Capsules 75 mg and 150 mg over failed impurity test
A 12-month stability test found impurity levels in these dabigatran etexilate capsules were out of specification for Impurity II, Impurity III and total impurities.
Ascend Laboratories, LLC · 924 cartons x 12 x 6 x 10
Ascend Laboratories recalls amlodipine and olmesartan tablets over low olmesartan content
The 10 mg/20 mg tablets failed dissolution specifications and contain less olmesartan medoxomil than they should, and 6,192 bottles were sold nationwide in the USA.
Ascend Laboratories, LLC · 6,192 bottles
Ascend Laboratories recalls dabigatran etexilate capsules over failed impurity test results
A 12-month stability test found impurity levels in the dabigatran etexilate capsules, 150 mg and 110 mg, that were outside the allowed limits for Impurity II, Impurity III and total impurities.
Ascend Laboratories, LLC · 4,470 units
Ascend Laboratories recalls Minocycline Hydrochloride Extended-Release Tablets after failed dissolution test
One test of the tablets at the 9th month gave a result outside the allowed limits for dissolution, and the notice lists 360 30-count bottles sold nationwide in the USA.
Ascend Laboratories, LLC · 360 30-count bottles
Ascend Laboratories recalls Metoprolol Succinate Extended-Release Tablets, 25 mg, over failed dissolution specifications
The tablets failed dissolution specifications, and the notice covers 17,304 100-count bottles sold across the U.S.
Ascend Laboratories, LLC · 17,304 100-count bottles