Ascend Laboratories Olmesartan Medoxomil Tablets Recall

Why it was recalled

Presence of Foreign Tablet/Capsule

Product description

Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.

Lot numbers, UPCs & expiration codes

Batch No. 20122548, Exp Date: Aug. 2022

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0392-2021
Classification: Class III
Status: Terminated
Recall initiated: Apr 29, 2021
FDA report date: Jun 2, 2021
Quantity: 34296 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Ascend Laboratories LLC

Original FDA data

Every field from FDA enforcement report D-0392-2021, exactly as published.

Show all FDA fields

City: Parsippany
State: NJ
Status: Terminated
Country: United States
Event ID: 87817
Address: 339 Jefferson Rd Ste 101
Code information: Batch No. 20122548, Exp Date: Aug. 2022
Postal code: 07054-3707
Report date: Jun 2, 2021
Product type: Drugs
Recall number: D-0392-2021
Classification: Class III
Recalling firm: Ascend Laboratories LLC
Product quantity: 34296 bottles
Termination date: Feb 17, 2023
Reason for recall: Presence of Foreign Tablet/Capsule
Voluntary / mandated: Voluntary: Firm initiated
Product description: Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.
Distribution pattern: Nationwide
Recall initiation date: Apr 29, 2021
Initial firm notification: Letter
Center classification date: May 24, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0392-2021, published Jun 2, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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