The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0095-2021·Announced 2020-11-25

Milbar Recalls DCL Clear Skin Anti-Blemish Hydrator Due to GMP Deviations

Milbar Laboratories is voluntarily recalling 927 tubes of DCL Clear Skin Anti-Blemish Hydrator due to Good Manufacturing Practice (GMP) deviations.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to GMP deviations rather than a specific high-risk pathogen or structural defect.

Plain-English summary

Milbar Laboratories, Inc. is voluntarily recalling 927 tubes of DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz. The recall was initiated on October 9, 2020, and is classified as Class II by the FDA. The reason for the recall is Good Manufacturing Practice (GMP) deviations.

The affected product is identified by Lot # FX432-5 and has an expiration date of June-21. The product was distributed throughout the United States, including Puerto Rico, and internationally. The recall was initiated by the firm and was terminated on January 4, 2023.

Consumers with this product should stop using it and contact the recalling firm for further instructions. The recall is voluntary and was initiated by the firm.

The recalled product

Product
DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Manufacturer
Milbar Laboratories, Inc.
Category
Drug — Dermatologic
Hazard
Affected units
927

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 (2)

  • Lot #: FX432-5
  • Exp. Date June-21

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 14 recalled by Milbar Laboratories, Inc. 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 14 products in this recall →

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