Medications & Supplements/Prescription Drugs

Medisca Bimatoprost Powder Recalled for Manufacturing Deviations

Agency Publication Date: April 21, 2025

Summary

Medisca Inc. has voluntarily recalled approximately 161.6 grams (162 units) of Bimatoprost powder, a bulk pharmaceutical ingredient. The recall was initiated because the product was manufactured under conditions that deviated from current Good Manufacturing Practices (cGMP), which are the required safety standards for drug production. This bulk ingredient is typically used by pharmacies to create customized medications; while no injuries have been reported, the manufacturing issues mean the quality and safety of the product cannot be guaranteed.

Risk

The manufacturing deviations could lead to products that do not meet identity, strength, quality, or purity standards. Using a medication made from compromised ingredients may result in ineffective treatment or unexpected side effects for patients.

What You Should Do

This recall involves Medisca Bimatoprost powder, a bulk ingredient used in making medications, which was sold in 1-gram and 5-gram drums under NDC codes 38779-3066-03, 38779-3066-06, and 38779-3066-09.
Check the labeling on the drum or packaging for lot numbers 201727 (suffixes A/B/C/D/E/F) with an expiration date of 05/31/2027, or lot number 208475 (suffixes A/B/D/E/G/H/I) with an expiration date of 09/30/2028.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Bimatoprost powder, Bulk Ingredient

Variants: 5g drum, 1g drum

Model:

3066

Lot Numbers:

201727/A (Exp 05/31/2027)

201727/B (Exp 05/31/2027)

201727/C (Exp 05/31/2027)

201727/D (Exp 05/31/2027)

201727/E (Exp 05/31/2027)

201727/F (Exp 05/31/2027)

208475/A (Exp 09/30/2028)

208475/B (Exp 09/30/2028)

208475/D (Exp 09/30/2028)

208475/E (Exp 09/30/2028)

208475/G (Exp 09/30/2028)

208475/H (Exp 09/30/2028)

208475/I (Exp 09/30/2028)

NDC:

38779-3066-03

38779-3066-06

38779-3066-09

Bulk pharmaceutical ingredient manufactured in Plattsburgh, NY.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96600

Status: Resolved

Manufacturer: Medisca Inc.

Sold By: Wholesalers; Compounding Pharmacies

Manufactured In: United States

Units Affected: 161.6 grams

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves Medisca Bimatoprost powder, a bulk ingredient used in making medications, which was sold in 1-gram and 5-gram drums under NDC codes 38779-3066-03, 38779-3066-06, and 38779-3066-09.

Check the labeling on the drum or packaging for lot numbers 201727 (suffixes A/B/C/D/E/F) with an expiration date of 05/31/2027, or lot number 208475 (suffixes A/B/D/E/G/H/I) with an expiration date of 09/30/2028.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Bimatoprost powder, Bulk Ingredient

Variants: 5g drum, 1g drum

Model:

3066

Lot Numbers:

201727/A (Exp 05/31/2027)

201727/B (Exp 05/31/2027)

201727/C (Exp 05/31/2027)

201727/D (Exp 05/31/2027)

201727/E (Exp 05/31/2027)

201727/F (Exp 05/31/2027)

208475/A (Exp 09/30/2028)

208475/B (Exp 09/30/2028)

208475/D (Exp 09/30/2028)

208475/E (Exp 09/30/2028)

208475/G (Exp 09/30/2028)

208475/H (Exp 09/30/2028)

208475/I (Exp 09/30/2028)

NDC:

38779-3066-03

38779-3066-06

38779-3066-09

Bulk pharmaceutical ingredient manufactured in Plattsburgh, NY.