The Recall Desk
ModerateFDA (Drugs)·D-0843-2016·Announced 2016-05-18

Sesderma Salises Acne Gel Recalled for cGMP Deviations

Sesderma is recalling Salises Facial Moisturizing Acne Treatment Gel due to cGMP deviations. The product does not comply with current Good Manufacturing Practice requirements.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text cites cGMP deviations without reporting specific injuries or illnesses, fitting the Moderate severity criteria for voluntary precautionary or compliance-based recalls.

Plain-English summary

Sesderma, SL is recalling 459 bottles of Salises Facial Moisturizing Acne Treatment Gel (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottles. The product is an over-the-counter medication manufactured in Valencia, Spain, with NDC 63181-0016.

The recall was initiated because the product does not comply with current Good Manufacturing Practice (cGMP) requirements. The agency has classified this as a Class II recall. The affected lots include lot 51004101 (exp 2/2020), lot 43394101 (exp 11/2019), and lot 33444101 (exp 11/2018).

The product was distributed to Florida, Puerto Rico, Colorado, and Georgia. Consumers should check their bottles for the specific lot codes and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact the manufacturer for further instructions.

The recalled product

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
Manufacturer
Sesderma, SL
Category
Drug — Topical Acne Treatment
Hazard
Affected units
459

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot code 51004101
  • exp 2/2020
  • lot 43394101
  • exp 11/2019
  • lot 33444101
  • exp 11/2018

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 10 recalled by Sesderma, SL under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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