Weekly digest

Latest FDA enforcement digest.

A public weekly read on notable FDA warning letters, recalls, and enforcement patterns.

FDA Monitor - Weekly FDA Digest

Week of May 13, 2026

**2 warning letters · 6 Class I recalls**

FDA Warning Letters

  • **Naveh Pharma LTD / Bigdam Inc.** - 2026-05-04
  • Category: Drugs / OTC finished pharmaceuticals
  • Tags: CGMP, adulterated products, unapproved new drug, quality systems
  • Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/naveh-pharma-ltdbigdam-inc-724669-05042026
  • **IDO Pharm Co., Ltd.** - 2026-05-04
  • Category: Drugs / OTC finished pharmaceuticals
  • Tags: CGMP, process validation, laboratory controls, quality unit
  • Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ido-pharm-co-ltd-723449-05042026

Class I Recalls

  • **Boston Scientific Corporation** - 2026-05-06
  • Source: https://www.accessdata.fda.gov/scripts/ires/index.cfm?recall_number=Z-1771-2026
  • **WHILL, INC.** - 2026-05-06
  • Source: https://www.accessdata.fda.gov/scripts/ires/index.cfm?recall_number=Z-1826-2026
  • **North American Rescue LLC** - 2026-05-06
  • Source: https://www.accessdata.fda.gov/scripts/ires/index.cfm?recall_number=Z-1947-2026
  • **HEMU TRADING INC** - 2026-05-06
  • Source: https://www.accessdata.fda.gov/scripts/ires/index.cfm?recall_number=H-0686-2026
  • **Costco Wholesale Corporation** - 2026-04-29
  • Source: https://www.accessdata.fda.gov/scripts/ires/index.cfm?recall_number=H-0682-2026
  • **Unistel Industries Inc.** - 2026-04-29
  • Source: https://www.accessdata.fda.gov/scripts/ires/index.cfm?recall_number=H-0666-2026

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