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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Allergan Sales, LLC: Combigan and Lumigan Eye Drops Recalled for Impurity Specification Failures

Agency Publication Date: November 13, 2017
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Summary

Allergan Sales, LLC has recalled approximately 868,657 bottles of prescription eye medications, specifically Combigan (brimonidine tartrate/timolol maleate) and Lumigan (bimatoprost). The recall was initiated because the products failed to meet required specifications for impurities and degradation during testing. Consumers should contact their healthcare provider or pharmacist regarding their medication and return any unused portions of the affected lots to their pharmacy for a refund.

Risk

The presence of impurities or degradation products beyond approved limits can reduce the effectiveness of the medication or potentially cause unexpected side effects during use. No specific injuries or adverse events have been reported in the current data, but the products no longer meet the quality standards required for patient safety.

What You Should Do

  1. Check your medication bottles for Combigan (brimonidine tartrate/timolol maleate) 0.2%/0.5% in 2.5 mL (NDC 0023-9211-03), 5 mL (NDC 0023-9211-05), 10 mL (NDC 0023-9211-10), or 15 mL (NDC 0023-9211-15) sizes.
  2. For Combigan, look for the following affected lot numbers and expiration dates: Lot 94659 (Exp. FEB-2019), Lot 94715 (Exp. JAN-2019), Lot 94757 (Exp. FEB-2019), Lot 94715A (Exp. JAN-2019), Lot 95297 (Exp. MAR-2019), Lot 95223 (Exp. MAR-2019), or Lot 95220 (Exp. MAR-2019).
  3. Check your Lumigan (bimatoprost) 0.01% 2.5 mL bottles (NDC 0023-3205-03) for Lot 92575 with an expiration date of JUN-2018.
  4. If you identify an affected lot, contact your healthcare provider or pharmacist immediately for guidance on your treatment and to obtain a replacement prescription.
  5. Return any unused bottles from these specific lots to the pharmacy where they were purchased to receive a refund.
  6. Contact Allergan Sales, LLC for further instructions or questions regarding this recall.
  7. For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall refund and consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% (2.5 mL)
Model:
NDC 0023-9211-03
Lot Numbers:
94659 (Exp. FEB-2019)
Date Ranges: Expiration February 2019
Product: Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% (5 mL)
Model:
NDC 0023-9211-05
Lot Numbers:
94715 (Exp. JAN-2019)
94757 (Exp. FEB-2019)
94715A (Exp. JAN-2019)
95297 (Exp. MAR-2019)
Date Ranges: Expiration January 2019 - March 2019
Product: Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% (10 mL)
Model:
NDC 0023-9211-10
Lot Numbers:
95223 (Exp. MAR-2019)
Date Ranges: Expiration March 2019
Product: Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% (15 mL)
Model:
NDC 0023-9211-15
Lot Numbers:
95220 (Exp. MAR-2019)
Date Ranges: Expiration March 2019
Product: Lumigan (bimatoprost ophthalmic solution) 0.01% (2.5 mL)
Model:
NDC 0023-3205-03
Lot Numbers:
92575 (Exp. JUN-2018)
Date Ranges: Expiration June 2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78325
Status: Resolved
Manufacturer: Allergan Sales, LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (715,041 bottles; 153,616 bottles)
Distributed To: Nationwide

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.