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Verified · FDAClass II — Possible RiskMedications

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per Recall 2026

AMLODIPINE AND OLMESARTAN MEDOXOMILIssued July 8, 2026Updated Reviewed by the Recall Watch editorial team

AMLODIPINE AND OLMESARTAN MEDOXOMIL 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 07 — recalled per FDA on 7/8/2026. Reason: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications.

Agency
FDA
Issued
Jul 8, 2026
Brand
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Distribution
1 states
Lots affected
2
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued July 8, 2026 · Last synced Nov 1, 2026

What's recalled

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

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Why it was recalled

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot 25121311
expiry 3/31/2028
Where was it sold
1 state

Nationwide in the USA

nationwide
Official noticefda.gov
More recalls like this
6 related — by brand, contaminant, and category

Frequently asked questions

Is the AMLODIPINE AND OLMESARTAN MEDOXOMIL recall still active?

Yes, this recall is currently active as of July 8, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot 25121311, expiry 3/31/2028. Check the label on your product.

What should I do if I have the recalled AMLODIPINE AND OLMESARTAN MEDOXOMIL?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.