The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0065-2019·Announced 2018-10-24

Product Quest Recalls Dr. Brandt BB Cream for Stability Failures

Product Quest Manufacturing LLC is recalling 9,480 tubes of Dr. Brandt BB Cream with SPF 30 due to failed stability specifications, including product separation.

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 temporary or medically reversible adverse health consequence. The source text does not report any illnesses or injuries, and the hazard is a stability failure (separation) rather than a high-risk pathogen or structural defect, fitting the Moderate criteria for low-risk contamination or voluntary precautionary measures.

Plain-English summary

Product Quest Manufacturing LLC is recalling 9,480 tubes of dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube. The product was distributed nationwide in the USA by Cosmetic Dermatology, Inc. The specific lot affected is 161223D, with an expiration date of 4/16/2019, and carries the UPC 6 63963 00828 7.

The recall was initiated because the product failed stability specifications, specifically resulting in the separation of the product and failure for actives. The U.S. Food and Drug Administration has classified this as a Class II recall.

Consumers who have purchased this specific lot of Dr. Brandt BB Cream should stop using the product and contact the distributor or retailer for a refund or replacement. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7.
Manufacturer
Product Quest Manufacturing LLC
Category
Drug — Cosmetic / OTC
Hazard
Affected units
9,480

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: 161223D
  • Exp. 4/16/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 54 recalled by Product Quest Manufacturing LLC 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 54 products in this recall →

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