CLASS II ONGOING Drug recall · Reported 18 May 2016 · FDA Enforcement Report
Salises Facial Moisturizing Acne Treatment Gel recalled by Sesderma, SL
Sesderma SL is recalling Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), over the counter, distributed in Colorado, Florida, Georgia, Puerto Rico. The recall was initiated on 15 Oct 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0843-2016
- FDA event ID
- 73574
- Recalling firm
- Sesderma SL, Rafelbunol, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Oct 2015
- FDA classified
- 10 May 2016
- Reported
- 18 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 15 Oct 2015 | Recall initiated by company | |
| 10 May 2016 | Classified by FDA | +208 days |
| 18 May 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations; product does not comply with cGMP requirements
Product as listed by the FDA
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
Where it was distributed
Distributed to following states: FL, PR, CO, GA.
Questions about this recall
Why was it recalled?
cGMP Deviations; product does not comply with cGMP requirements
Which lots are affected?
Lot code 51004101, exp 2/2020, lot 43394101, exp 11/2019, lot 33444101, exp 11/2018
Where was it sold?
Distributed to following states: FL, PR, CO, GA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 73574This product is part of a recall event; the main page for the event is Screenses Color Sunscreen, Tinted facial make-up compact recalled.
More recalls from Sesderma SL
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dryses Aluminum Chlorohydrate Deodorant for Women, Roll recalled | Sesderma SL | Manufacturing (CGMP) Deviations | 4 states |
| Drug | CLASS II | Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate recalled | Sesderma SL | Manufacturing (CGMP) Deviations | 4 states |
| Drug | CLASS II | Screenses Color Sunscreen Tinted facial make-up compact recalled | Sesderma SL | Manufacturing (CGMP) Deviations | 4 states |
| Drug | CLASS II | Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate recalled | Sesderma SL | Manufacturing (CGMP) Deviations | 4 states |
| Drug | CLASS II | Repaskin 50 (octocrylene recalled by Sesderma, SL | Sesderma SL | Manufacturing (CGMP) Deviations | 4 states |