Salises Facial Moisturizing Acne Treatment Gel — Class II drug recall D-0843-2016
Ongoing recall by Sesderma, SL, reported 2016-05-18, distributed in CO, FL, GA, PR. cGMP Deviations; product does not comply with cGMP requirements
| Recall number | D-0843-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sesderma, SL, Rafelbunol, N/A, Spain |
| Recall initiated | 2015-10-15 |
| Classified | 2016-05-10 |
| Reported by FDA | 2016-05-18 |
| Distributed | CO, FL, GA, PR |
| Quantity | 459 bottles |
| Reason classes | cgmp |
| Lot numbers | 33444101, 43394101, 51004101 |
| Expiration dates | 2018-11, 2019-11, 2020-02 |
Product
Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016
Reason for recall
cGMP Deviations; product does not comply with cGMP requirements
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-0843-2016. 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.