FML — Class II drug recall D-1819-2015
Terminated recall by Allergan Sales, LLC, reported 2015-09-30, distributed nationwide. Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the
| Recall number | D-1819-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allergan Sales, LLC, Waco, TX, United States |
| Recall initiated | 2015-08-24 |
| Classified | 2015-09-22 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2017-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB |
| Quantity | 28,292 tubes |
| Reason classes | specification failure |
| NDC | 00023-0316-04 |
| Lot numbers | 02/17, 09/16, 12/16, 86258, 87189, 87514 |
Product
FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.
Reason for recall
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
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-1819-2015. 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.