Combigan — Class III drug recall D-0077-2018
Terminated recall by Allergan Sales, LLC, reported 2017-11-22, distributed nationwide. Failed Impurities/Degradation Specifications.
| Recall number | D-0077-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allergan Sales, LLC, Waco, TX, United States |
| Recall initiated | 2017-10-19 |
| Classified | 2017-11-13 |
| Reported by FDA | 2017-11-22 |
| Terminated | 2019-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, CW, DO, GY, JM, TT |
| Quantity | 715,041 bottles |
| Reason classes | specification failure |
| NDC | 00023-9211, 00023-9211-03, 00023-9211-05, 00023-9211-10, 00023-9211-15 |
Product
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..
Reason for recall
Failed Impurities/Degradation Specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0077-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.