The Recall Desk
ModerateFDA (Drugs)·D-0089-2021·Announced 2020-11-25

Milbar Recalls Malin + Goetz Salicylic Gel Due to GMP Deviations

Milbar Laboratories is recalling 2,664 tubes of Malin + Goetz Salicylic Gel due to Good Manufacturing Practice (GMP) deviations.

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 due to GMP deviations, which aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/process errors without reported serious injury.

Plain-English summary

Milbar Laboratories, Inc. is voluntarily recalling 2,664 tubes of (Malin + Goetz) Salicylic Gel (2% Salicylic Acid), 0.5 fl.oz. (15 mL). The product is distributed by Malin+Goetz Inc. The recall is being conducted due to Good Manufacturing Practice (GMP) deviations.

The affected product is identified by Lot # MV678 with an expiration date of December 2021. The product was distributed throughout the United States, including Puerto Rico, and internationally.

The FDA has classified this recall as Class II, which indicates a situation in which there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The recall was initiated on October 9, 2020, and was terminated on January 4, 2023.

The recalled product

Product
(Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
Manufacturer
Milbar Laboratories, Inc.
Category
Drug — Topical Dermatological
Hazard
Affected units
2,664

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 #: MV678
  • Exp. Date Dec-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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