The Recall Desk
HighFDA (Drugs)·D-0386-2025·Announced 2025-04-30

FDA Recalls Bimatoprost Powder Bulk Ingredient for Manufacturing Defects

Medisca Inc. is voluntarily recalling bimatoprost powder bulk ingredient due to manufacturing practice deviations. The product was distributed nationwide in the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall without reported illnesses or hospitalizations. The hazard—manufacturing practice deviations—is a theoretical risk to drug quality without documented adverse events, placing this in the high-risk category where injury has not been reported.

Plain-English summary

Medisca Inc. is recalling bimatoprost powder, a bulk active pharmaceutical ingredient distributed across the United States. The recalled product is supplied in three sizes: 5-gram drums and two 1-gram drum sizes, with specific NDC numbers listed. Approximately 161.6 grams of product are affected by this recall.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered at the Medisca manufacturing facility in Plattsburgh, New York. CGMP violations indicate that the manufacturing process did not meet regulatory standards for pharmaceutical ingredient production. The firm voluntarily initiated this recall on March 31, 2025.

The affected product was distributed nationwide. Specific lot numbers include Lot# 201727/A/B/C/D/E & F (expiring May 31, 2027) and Lot# 208475/A/B/D/E/G/H & I (expiring September 30, 2028). Healthcare facilities and pharmaceutical manufacturers who received these ingredient lots should verify their inventory against the provided lot numbers.

The FDA classified this as a Class II recall. Healthcare professionals and compounding pharmacies should not dispense or use products manufactured with affected lots. If affected product has been distributed, it should be quarantined and returned to Medisca Inc. The recall was terminated on October 10, 2025.

The recalled product

Product
Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY
Manufacturer
Medisca Inc.
Category
Drug — Bulk Pharmaceutical Ingredient
Hazard
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot# 201727/A/B/C/D/E & F
  • exp. date 05/31/2027
  • product # 3066 Lot# 208475/A/B/D/E/G/H & I
  • exp. date 09/30/2028
  • product # 3066

Distribution

Distributed nationwide across the United States.

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