Fabior — Class III drug recall D-0616-2018
Terminated recall by Mayne Pharma Inc, reported 2018-04-11, distributed nationwide. Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
| Recall number | D-0616-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mayne Pharma Inc, Greenville, NC, United States |
| Recall initiated | 2018-03-21 |
| Classified | 2018-03-30 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2020-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 3,312 cans |
| Reason classes | potency, specification failure |
| NDC | 51862-0295, 51862-0295-10, 51862-0295-50 |
| Expiration dates | 2019-01-31 |
Product
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
Reason for recall
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
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-0616-2018. 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.