Salises Acne Treatment Gel (Sesderma) – Manufacturing Quality Issue (2015)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Sesderma, SL
Lot Codes / Batch Numbers
Lot code 51004101, exp 2/2020, lot 43394101, exp 11/2019, lot 33444101, exp 11/2018
Products Sold
Lot code 51004101, exp 2/2020, lot 43394101, exp 11/2019, lot 33444101, exp 11/2018
Sesderma, SL is recalling Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, ov due to cGMP Deviations; product does not comply with cGMP requirements. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP Deviations; product does not comply with cGMP requirements
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, FL, GA, PR
Page updated: Jan 7, 2026