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Verified · FDAClass II — Possible RiskMedications

Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only Recall 2026

AMLODIPINE AND OLMESARTAN MEDOXOMILIssued October 6, 2026Updated Reviewed by the Recall Watch editorial team

AMLODIPINE AND OLMESARTAN MEDOXOMIL Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877- — recalled per FDA on 10/6/2026. Reason: Out of specification due to dissolution..

Agency
FDA
Issued
Oct 6, 2026
Brand
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Distribution
1 states
Lots affected
3
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 October 6, 2026 · Last synced Nov 2, 2026

What's recalled

Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-502-30.

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Why it was recalled

Out of specification due to dissolution.

Affected products & lot numbers
3 lots called out

Affected Lot Numbers

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

Lot Number
Lot # 25120696
Exp Date: December 31
2026.
Where was it sold
1 state

Nationwide within the United States

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 October 6, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot # 25120696, Exp Date: December 31, 2026.. 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.