Quality & complianceOfficial

FDA lists Class II recall of Macleods olmesartan medoxomil over failed dissolution specifications

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

Macleods Pharma USA's olmesartan medoxomil recall, numbered D-0077-2027, is ongoing and covers nationwide distribution in the United States, according to the FDA enforcement report.

The US Food and Drug Administration has published a Class II recall of olmesartan medoxomil from Macleods Pharma USA, Inc in its enforcement report dated 4 November 2026. The recall is numbered D-0077-2027.

The stated reason is failed dissolution specifications. In practice, this means the product did not meet the dissolution requirements set for it. The record gives no further detail on the failing test, the stage at which it was detected, or the results obtained.

The FDA lists the recall status as ongoing. Distribution is described as nationwide in the USA.

The text available for this item consists largely of search-page navigation from the FDA's enforcement report database. It does not include the product strengths, lot numbers, expiry dates, quantities or the recall initiation date. Those details would normally appear in the full database entry.

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

What it means for your team

  • Quality teams should check the full FDA enforcement report entry for D-0077-2027 to confirm affected strengths, lots and expiry dates before acting.
  • Supply chain and market-access teams handling olmesartan medoxomil from this manufacturer should confirm whether any of their stock is within scope of the nationwide recall.
  • Dissolution failures are a reminder to review release and stability testing trends for oral solid dosage forms, including dissolution method performance.

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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