CLASS II Drug recall · Reported 30 Apr 2025 · FDA Enforcement Report
Bimatoprost powder, Bulk Ingredient, a) recalled by Medisca
Medisca is recalling Bimatoprost powder, Bulk Ingredient, a) (, distributed nationwide in the US. The recall was initiated on 31 Mar 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0386-2025
- FDA event ID
- 96600
- Recalling firm
- Medisca, Irving, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Mar 2025
- FDA classified
- 21 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 31 Mar 2025 | Recall initiated by company | |
| 21 Apr 2025 | Classified by FDA | +21 days |
| 30 Apr 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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
Where it was distributed
US Nationwide.
Questions about this recall
Is Bimatoprost powder, Bulk Ingredient, a) ( recalled?
Yes. Medisca recalled Bimatoprost powder, Bulk Ingredient, a) ( on 31 Mar 2025. The recall is Class II and its status is Terminated. Recall number D-0386-2025.
Why was it recalled?
CGMP Deviations
Which lots are affected?
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
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Bimatoprost recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Bimatoprost Ophthalmic Solution recalled by SandozBimatoprost | Sandoz | Sterility | Nationwide |
| Drug | CLASS III | Lumigan (bimatoprost ophthalmic solution) recalled by Allergan SalesLumigan | Allergan Sales | Potency & Assay | Nationwide |
| Drug | CLASS III | Lumigan (bimatoprost ophthalmic solution) recalled by Allergan SalesLumigan | Allergan Sales | Potency & Assay | Nationwide |