Allergan Combigan Ophthalmic Solution Recall: Impurities Risk
Allergan recalls Combigan eye drops (0.2%/0.5%) due to failed impurities and degradation specifications. Affected lots expire by Feb 2019. Consumers should contact Allergan for details.
Recall notice
Failed Impurities/Degradation Specifications.
Contact the company
What happened, in plain English
Allergan is recalling certain lots of Combigan eye drops (brimonidine tartrate/timolol maleate) because they failed impurities and degradation tests. This could pose a risk to users, though the exact danger isn't specified in the recall notice. Read more at govinfonow.com/recall/41125-allergan-combigan-ophthalmic-solution-recall-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41125-allergan-combigan-ophthalmic-solution-recall-impurities-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0077-2018
Cite this page
“Allergan Combigan Ophthalmic Solution Recall: Impurities Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41125-allergan-combigan-ophthalmic-solution-recall-impurities-risk. Based on FDA recall #D-0077-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0077-2018%22&limit=1).
Why it’s dangerous
The eye drops failed impurities and degradation specifications, which means they may contain harmful substances or break down in a way that could affect safety. However, the recall does not specify the exact risk level or how it could cause harm.
Who’s affected
People who have the specific Combigan eye drops listed in the recall (0.2%/0.5% solution) and were prescribed by a doctor. Those using the affected lots are most at risk.
How to tell if you have this one
Check the product label for the 0.2%/0.5% concentration and the NDC numbers: 0023-9211-03 (2.5mL), 0023-9211-05 (5mL), 0023-9211-10 (10mL), or 0023-9211-15 (15mL). Also look for the lot numbers listed: 94659, 94715, 94757, 94715A, 95297, 95223, or 95220.
- Brand
Allergan- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0077-2018 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..; Lot #: a) 94659 Exp. FEB-2019; b) 94715, Exp. JAN-2019; 94757, Exp. FEB-2019, 94715A, Exp. JAN-2019; 95297, Exp. MAR-2019; c) 95223 Exp. MAR-2019; d) 95220 Exp. MAR-2019 | 715,041 bottles | 0023-9211-03, 0023-9211-05, 0023-9211-10, 0023-9211-15 |
| D-0078-2018 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03; Lot #: 92575 Exp. JUN-2018 | 153,616 bottles | 0023-3205-02, 0023-3205-03, 0023-3205-05, 0023-3205-08 |
What to do — step by step
Check Product Details
Look for the NDC numbers and lot numbers listed in the recall to confirm if your Combigan eye drops are affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0077-2018 (October 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0077-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.