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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ascend Laboratories LLC: Olmesartan Medoxomil Tablets Recalled Due to Presence of Foreign Medication

Agency Publication Date: May 24, 2021
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Summary

Ascend Laboratories LLC is recalling 34,296 bottles of Olmesartan Medoxomil tablets (20 mg), a medication used to treat high blood pressure. The recall was issued because a foreign tablet or capsule was discovered inside a bottle of the product. Ingesting an unidentified or incorrect medication can lead to serious health risks, including unintended side effects or lack of proper treatment for your condition. The affected products were distributed nationwide in 30-count bottles and were manufactured by Alkem Laboratories Ltd.

Risk

The presence of a foreign tablet or capsule means consumers may accidentally ingest the wrong medication. This poses a risk of adverse drug reactions or potential interactions with other medications the patient may be taking.

What You Should Do

  1. Check your prescription bottle label for the name Olmesartan Medoxomil Tablets, USP, 20 mg and the identification number NDC 67877-446-30.
  2. Verify if your bottle is part of Batch No. 20122548 with an expiration date of August 2022 (Aug. 2022).
  3. If your bottle matches these details, examine the tablets inside to see if any look different in size, color, or shape from the others.
  4. Contact your healthcare provider or pharmacist immediately for guidance if you suspect you have an affected bottle or have concerns about your medication.
  5. Return any unused product from the affected batch to the pharmacy where you purchased it for a refund.
  6. Contact the distributor, Ascend Laboratories LLC, for further instructions regarding this recall.
  7. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Return for refund and pharmacist consultation.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Olmesartan Medoxomil Tablets, USP, 20 mg (30 Tablets)
Model:
NDC 67877-446-30
Recall #: D-0392-2021
Lot Numbers:
20122548 (Exp Aug. 2022)
Date Ranges: Expiration Date: August 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87817
Status: Resolved
Manufacturer: Ascend Laboratories LLC
Manufactured In: India, United States
Units Affected: 34296 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.