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.
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Ascend Laboratories is recalling 5mg/40mg Amlodipine and Olmesartan Medoxomil tablets (Rx only) because they may contain less active drug than labeled. This could mean the medication isn't working as intended for blood pressure control.
The tablets may not dissolve properly in the body, leading to lower than expected drug levels. This could result in the medication not working effectively for blood pressure control.
People with a prescription for these blood pressure tablets who bought them from Ascend Laboratories in the U.S. are affected. Those with high blood pressure who rely on these medications are most at risk.
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.
Verify the product label matches the recalled items: 30-count bottle, 5mg/40mg, Rx Only, manufactured by Alkem Laboratories.
The tablets may have lower than expected drug content due to failed dissolution specifications, which could reduce effectiveness for blood pressure control.
No, but you should check if you have the recalled product and contact your doctor if you're unsure about your medication's effectiveness.
The recall record does not specify a remedy, so you should check with your doctor about whether to continue using the medication.
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0556-2026 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0556-2026 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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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.
