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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Bimatoprost, Finasteride, and Other Drugs Recalled for Manufacturing Deviations

Agency Publication Date: March 10, 2025
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Summary

Aspen Biopharma Labs Pvt., Ltd. is recalling approximately 682 units of various medications, including Bimatoprost, Finasteride, and Latanoprost, due to manufacturing deviations (CGMP deviations). These products, which also include Alprostadil, Chlorambucil, and Voriconazole, were distributed to distributors in Florida and Hong Kong. Because these products were produced under conditions that did not meet quality standards, their safety and effectiveness cannot be guaranteed.

Risk

Manufacturing deviations indicate that the facility did not follow required safety and quality control standards during production. This could lead to products with incorrect potency or potential contamination, which may cause adverse health effects for patients using medications made from these ingredients.

What You Should Do

  1. This recall affects several pharmaceutical products including Bimatoprost, Alprostadil, Finasteride, Chlorambucil, Latanoprost, and Voriconazole manufactured by Aspen Biopharma Labs Pvt., Ltd. in various quantities from 3.0 grams to 120.0 kilograms.
  2. Check your product labeling for identifiers including Bimatoprost (NDC 82187-1001-1), Finasteride (NDC 82187-1003-1), or Latanoprost (NDC 82187-1002-1). See the Affected Products section below for the full list of affected codes.
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 (400.0 gm)
Lot Numbers:
HABTC0020123 (Exp Dec-2026)
HABTC0050623 (Exp May-2027)
HABTC0091023 (Exp Sep-2028)
NDC:
82187-1001-1

Packed in double self-seal cover and finally packed in Aluminum cover for shipping. Recall #: D-0260-2025

Product: Alprostadil (3.0 gm)
Lot Numbers:
HAALC0020922 (Exp AUG-2025)

Amber color bottle. Recall #: D-0261-2025

Product: Finasteride (120.0 kg)
Lot Numbers:
HAFSC0040923 (Exp Aug-2027)
HAFSC0050923 (Exp Aug-2027)
NDC:
82187-1003-1

Packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. Recall #: D-0262-2025

Product: Chlorambucil (5.1 kg)
Lot Numbers:
HACUC0010722 (Exp Jun-2025)
HACUC0010123 (Exp Dec-2025)

Packed in double self-seal cover and finally packed in Aluminum cover for shipping. Recall #: D-0263-2025

Product: Latanoprost (150.0 gm)
Lot Numbers:
HALAC0010123 (Exp Dec-2026)
HALAC0050923 (Exp Aug-2027)
NDC:
82187-1002-1

Amber colour bottle. Recall #: D-0264-2025

Product: Voriconazole (4.0 kg)
Lot Numbers:
HAVZC0020922 (Exp AUG-2026)

Packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. Recall #: D-0265-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96209
Status: Active
Manufacturer: Aspen Biopharma Labs Pvt., Ltd.
Sold By: Distributors in Florida; Distributors in Hong Kong
Manufactured In: India
Units Affected: 6 products (400.0 gm; 3.0 gm; 120.0 kg; 5.1 kg; 150.0 gm; 4.0 kg)
Distributed To: Florida
Agency Last Updated: November 12, 2025

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 ยท 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.