Quality & complianceOfficial

FDA classifies Ascend Laboratories amlodipine/olmesartan tablet recall as Class II over dissolution failure

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

Recall D-0045-2027 covers amlodipine and olmesartan medoxomil tablets distributed nationwide in the US and remains ongoing, according to the FDA enforcement report.

The US Food and Drug Administration has listed a Class II recall of Amlodipine and Olmesartan Medoxomil Tablets from Ascend Laboratories, LLC in its enforcement report dated 28 October 2026. The recall carries the number D-0045-2027.

The stated reason is that the product was out of specification for dissolution. Dissolution testing measures how quickly and how fully the active ingredients are released from a tablet under controlled laboratory conditions.

The enforcement report shows the recall as ongoing and notes distribution nationwide within the United States. The material available does not include details such as lot numbers, quantities, expiry dates or the number of batches affected, nor does it describe any adverse events linked to the product.

For context, the FDA assigns Class II to recalls where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Quality teams should treat dissolution out-of-specification results as a recall trigger, and review release and stability testing for similar combination tablets.
  • Supply-chain and market-access teams should check whether affected stock sits in their US distribution channels, using the full recall record for lot-level information.
  • Pharmacovigilance teams may want to monitor for reports of reduced efficacy with amlodipine/olmesartan products, although the source cites no adverse events.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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