FDA-Drug2026-07-29Class IICHEMICAL

Ascend Laboratories amlodipine-olmesartan tablets recalled for substandard active ingredient

UNDECLARED INGREDIENTSNationwide distribution

Ascend amlodipine-olmesartan tablets recalled for low drug content

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.
Hazard

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

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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