Quality & complianceOfficial

FDA classifies Fei Fah Medical's 'ULTRA STRENTGH' drug recall as Class II over CGMP deviations

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The ongoing nationwide US recall, numbered D-0104-2027, was listed in the FDA enforcement report dated 4 November 2026 and cites deviations from current good manufacturing practice.

The US Food and Drug Administration has published a Class II drug recall for a product listed as 'ULTRA STRENTGH', made by Singapore-based Fei Fah Medical Manufacturing Pte. Ltd. The entry appears in the agency's enforcement report dated 4 November 2026.

The recall is numbered D-0104-2027 and the stated reason is CGMP deviations, meaning departures from current good manufacturing practice. The status is shown as ongoing, so the recall has not yet been closed.

The product is recorded as distributed nationwide within the United States. The spelling 'STRENTGH' is reproduced as it appears in the FDA entry title.

The material available for this report does not give the product's active ingredient, dosage form, lot numbers, expiry dates, quantities or the specific manufacturing deficiencies involved. For context, the FDA applies a Class II designation where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote.

What it means for your team

  • Wholesalers, distributors and pharmacies in the US should check the full FDA enforcement report entry for D-0104-2027 for product and lot details before taking any action.
  • Quality teams may wish to review supplier qualification and CGMP oversight for products sourced from contract or overseas manufacturers, as this recall is attributed to CGMP deviations.
  • Because the recall is ongoing and nationwide, its scope could still change; teams should monitor the FDA record for updates.

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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