Class II · Moderate risk
Bimatoprost NDC# 82187-1001-1 Container description: The…
CGMP Deviations
Bimatoprost powder
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDCs
38779-3066-03
38779-3066-06
38779-3066-09
Compare with the code on your package — it is the most precise check available.
Drug: Bimatoprost
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Bimatoprost NDC 38779-3066 |
1 g/g | Powder | Medisca Inc. | BULK INGREDIENT |
- Recalling firm
- Medisca Inc.
- NDC code
- 38779-3066-03
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0386-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Bimatoprost recalls
See all
Class III · Low risk
Bimatoprost Ophthalmic Solution
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Class III · Low risk
Bimatoprost Ophthalmic Solution 0.03%
Labeling: Incorrect or missing package insert.
Class III · Low risk
Bimatoprost Ophthalmic Solution 0.03%
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation Specifications.
Other recalls by Medisca Inc.
All 2025 recalls
Class II · Moderate risk
Budesonide
CGMP Deviations and Presence of Particulate Matter: Glass
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Aminocaproic Acid
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Class II · Moderate risk
Estradiol
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
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