FDA-Drug2026-07-29Class IICHEMICAL

Ascend Laboratories amlodipine-olmesartan tablets recalled for substandard active ingredient

UNDECLARED INGREDIENTSNationwide distributionDrugs

What this means

Ascend Laboratories is recalling one lot of amlodipine and olmesartan medoxomil combination tablets (10 mg/20 mg) because the olmesartan medoxomil active ingredient is below the required amount. This means affected tablets may not work as intended to lower blood pressure.

  • Check if your amlodipine-olmesartan tablets are from lot 25121311 (expiration 3/31/2028).
  • Contact your pharmacy or doctor if you have this lot — do not stop taking your blood pressure medication without medical guidance.
  • Your pharmacist or doctor can provide a replacement or alternative medication.
The agency's original wording
Hazard

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
6,192 bottles
Manufactured in
135 Us Highway 202 206 Ste 15, N/A, Bedminster, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0712-2026

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