Severity
Moderate
FDA Drug recall · Reported April 30, 2025
CGMP Deviations
Medisca Inc. recalled Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06)… - a moderate-severity action.
Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06)… was recalled by Medisca Inc. in April 30, 2025. Reason: CGMP Deviations. Check the official notice for the remedy. Verify recall #D-0386-2025 with the FDA Drug before acting.
The recall
Medisca Inc. issued this moderate-severity FDA Drug recall-CGMP Deviations.
Sourced from official FDA Drug enforcement records. Verify recall #D-0386-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0386-2025) was formally reported on April 30, 2025, with the manufacturer initiating the action on March 31, 2025. It is classified under Moderate severity (Class II), with a current status of Terminated. Medisca Inc. is listed as the recalling firm, operating out of Irving, TX. Federal records list the affected scope as 161.6 grams.
The documented reason for this recall is: CGMP Deviations Distribution data in the federal record shows the product reached: US Nationwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
161.6 grams
Related Recalls
6
5 from same agency
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
CGMP Deviations
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0386-2025 |
| Date reported | April 30, 2025 |
| Date initiated | March 31, 2025 |
| Recalling firm | Medisca Inc. |
| Firm location | Irving, TX |
| Affected scope | 161.6 grams |
| Distribution | US Nationwide. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
AbbVie Inc. · 2026-06-03
Llorens Pharmaceuticals International Division, Inc. · 2026-05-27
Safecor Health, LLC · 2026-05-27
IntegraDose Compounding Services LLC · 2026-05-27
Lupin Pharmaceuticals Inc. · 2026-05-27
Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported April 30, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.