The Recall Desk
ModerateFDA (Drugs)·D-0091-2021·Announced 2020-11-25

Milbar Recalls MD Complete Breakout Treatment Due to GMP Deviations

Milbar Laboratories is voluntarily recalling 2,655 bottles of MD Complete Breakout Treatment due to Good Manufacturing Practice 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 low-risk contamination or voluntary precautionary recalls without reported injuries.

Plain-English summary

Milbar Laboratories, Inc. is voluntarily recalling 2,655 bottles of MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles. The product is manufactured by Milbar Laboratories, Inc. and distributed by MD Professional LLC in Minneapolis, MN. The specific lot affected is DX278 with an expiration date of Apr-23.

The recall was initiated because of Good Manufacturing Practice (GMP) deviations. The FDA has classified this recall as Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The product was distributed throughout the United States, including Puerto Rico, and internationally. Consumers who have this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN
Manufacturer
Milbar Laboratories, Inc.
Category
Drug — Topical OTC
Hazard
Affected units
2,655

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 #: DX278
  • Exp. Date Apr-23

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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