The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0386-2025·Announced 2025-04-30

Bimatoprost Bulk Powder Recalled by Medisca for CGMP Deviations

Medisca Inc. is voluntarily recalling Bimatoprost bulk powder in three sizes due to manufacturing process deviations. The powder was distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for CGMP deviations with no reported illness or injury. Per the rubric, Class II recalls without hospitalization reports or reported adverse events typically score as Moderate (2).

Plain-English summary

Medisca Inc. is voluntarily recalling Bimatoprost powder (bulk ingredient) distributed nationwide. The recall affects three product sizes: 5g drums (NDC 38779-3066-03), and two 1g drum configurations (NDC 38779-3066-06 and NDC 38779-3066-09). The affected lots are 201727/A/B/C/D/E & F (expiration 05/31/2027) and 208475/A/B/D/E/G/H & I (expiration 09/30/2028), totaling 161.6 grams.

The recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) standards. Medisca initiated the recall voluntarily on March 31, 2025, and the FDA classified it as Class II on April 21, 2025. The recall was terminated on October 10, 2025.

Healthcare professionals and compounding facilities that received this product should quarantine and dispose of the affected lots according to applicable regulations. Do not use the product.

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 Ingredient
Hazard

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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