Lower riskDrug recall · FDA · Published May 5, 2026
Ascend Laboratories recalls 5mg/40mg blood pressure tablets due to low drug content
Ascend Laboratories recalls 5mg/40mg Amlodipine and Olmesartan Medoxomil tablets (Rx only) manufactured by Alkem Labs in India. The tablets may have lower than expected drug content, potentially reducing effectiveness for blood pressure control.
“Ascend Laboratories recalls 5mg/40mg blood pressure tablets due to low drug content.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31316-ascend-laboratories-recalls-5mg-40mg-blood-pressure-tablets-due-to. Based on FDA recall #D-0556-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0556-2026%22&limit=1).
Ascend Laboratories, LLC recalled Amlodipine and Olmesartan Medoxomil Tablets due to failed dissolution specifications, the FDA said on May 5, 2026. The agency announced the voluntary Class II recall of 15,696 bottles distributed nationwide.
The recall addresses Olmesartan Medoxomil content falling below specifications due to failed dissolution. FDA's FAERS database contains 188 adverse-event reports naming this product, including 124 marked serious and 11 listing a death, though these are unverified reports not findings about this recall.
Context
GovInfoNow's records show Ascend Laboratories, LLC has 35 other recalls on record since November 2, 2016. Other recent recalls by the brand include Dabigatran Etexilate Capsules due to impurity risk (July 16, 2026), Amlodipine/Olmesartan tablets with low drug content (July 8, 2026), and Dabigatran etexilate capsules due to impurity risks (June 30, 2026). Other recent recalls of similar products include Inventia Healthcare Chlorthalidone Tablets Recall: Failed Dissolution Specifications (June 5, 2026), Major Pharmaceuticals Levothyroxine Tablets Recall: Subpotent Drug Risk (July 13, 2026), and Unichem busPIRone 5mg Tablets Recall: Subpotent Drug Risk (April 13, 2026).
How to tell if you have this one
Look for the 30-count bottle labeled 'Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only'. The product was manufactured by Alkem Laboratories in India and distributed by Ascend Laboratories in Parsippany, NJ. The lot number is 24123460 and expires October 31, 2027.
Brand
Ascend Laboratories
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Medication Details
Verify the product label matches the recalled items: 30-count bottle, 5mg/40mg, Rx Only, manufactured by Alkem Laboratories.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 36 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0556-2026 (May 5, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0556-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.