Barrier Therapy Skin Protectant Cream recalled for microbial contamination
Prequel Skin is recalling Barrier Therapy Skin Protectant Cream due to microbial contamination. The recall affects approximately 30,946 tubes distributed nationwide and online.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall for microbial contamination of a topical product. Although contamination presents a potential health risk, no illnesses or injuries have been reported. The hazard is categorized as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Prequel Skin is recalling Barrier Therapy Skin Protectant Cream (1% colloidal oatmeal) due to microbial contamination of the product. The affected product is available in 10 FL OZ/296 ML tubes.
The specific lots under recall are: X4054A (expiration 2/2026), X4136A, X4137A, and X4138A (expiration 5/2026). Approximately 30,946 tubes are affected. The product was distributed nationwide in the United States and online by Prequel Skin, located in Los Angeles, California (UPC 8 10129 11007 4).
Consumers who have purchased this product should discontinue use and dispose of it safely. For questions or concerns, consumers are advised to contact the FDA or the recalling firm.
The recalled product
- Product
- BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4
- Manufacturer
- PREQUEL SKIN
- Category
- Drug — Topical Protectant
- Hazard
- Affected units
- 30,946
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: X4054A
- Exp: 2/2026
- X4136A
- X4137A
- X4138A
- Exp: 5/2026
Distribution
Distributed nationwide across the United States.
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