Ascend Laboratories LLC recalls Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai -
Ascend Laboratories recalls 20mg Olmesartan Medoxomil tablets due to manufacturing errors. This medication was released with an alternate active ingredient before approval. Consumers should contact the company for details.
Lower-risk recall
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Contact the company & request your remedy
What happened, in plain English
Ascend Laboratories is recalling 20mg Olmesartan Medoxomil tablets that were manufactured with an alternate active ingredient before regulatory approval. This could lead to incorrect medication being taken, which may cause health issues. Read more at govinfonow.com/recall/37400-ascend-laboratories-recalls-olmesartan-medoxomil-tablets-20mg-cpg-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/37400-ascend-laboratories-recalls-olmesartan-medoxomil-tablets-20mg-cpg-deviations · Updated October 5, 2026 · FDA enforcement record: FDA #D-0828-2020
Cite this page
“Ascend Laboratories recalls Olmesartan Medoxomil Tablets 20mg: CPG Deviations.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37400-ascend-laboratories-recalls-olmesartan-medoxomil-tablets-20mg-cpg-deviations. Based on FDA recall #D-0828-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0828-2020%22&limit=1).
Why it’s dangerous
The tablets were released with an alternate active ingredient before regulatory approval. This means the medication might not work as intended or could cause unintended side effects. The risk is primarily for people taking the medication as prescribed.
Who’s affected
Prescription medication users in the U.S. who received this specific tablet product. Those with pre-existing conditions requiring precise medication dosing are at higher risk.
How to tell if you have this one
Look for the product name 'Olmesartan Medoxomil Tablets 20 mg', manufactured by Alkem Laboratories Ltd. in Mumbai, India. The NDC code is 67877-446-90. The lot number is 19122552, with an expiration date of July 31, 2021.
- Brand
Ascend Laboratories- Category
Drug
What to do — step by step
Contact Manufacturer
Reach out to Ascend Laboratories for specific instructions on how to handle the recalled product.
Questions people ask
Is this product safe to use?
The recall indicates a manufacturing error, but the product may still be safe for use if not taken as prescribed. Consult the manufacturer for details.
How can I check if I have the recalled product?
Check the product label for the NDC code 67877-446-90, lot number 19122552, and expiration date of July 31, 2021.
What should I do if I have the recalled product?
Contact Ascend Laboratories directly for specific instructions on how to handle the recalled product.
Contact Ascend Laboratories
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0828-2020 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0828-2020 from Ascend Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0828-2020 (January 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0828-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.