Moderate riskFDA DrugClass II

Ascend amlodipine/olmesartan tablets recalled for failed dissolution

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.

From the FDA notice · Read the official notice ↗ · All Ascend Laboratories recalls

What to do

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

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
6,192 bottles
Illnesses reported
None reported
Manufactured in
135 Us Highway 202 206 Ste 15, N/A, Bedminster, NJ, United States
Classification
Class II
Recall number
D-0712-2026

In the FDA's words

Description
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 Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications Lot 25121311, expiry 3/31/2028 Distribution: Nationwide in the USA Affected quantity: 6,192 bottles
Hazard
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

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