BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal) recall
FDA recall D-0657-2024 · initiated Aug 28, 2024
PREQUEL SKIN recalled BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal) in Aug 2024 — an FDA Class II recall (D-0657-2024) because Microbial contamination of non-sterile Products -.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Microbial contamination of non-sterile Products -
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 30,946 tubes
Details
- 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
- Recalling company
- PREQUEL SKIN
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed nationwide in USA and on line
- Initiated
- Aug 28, 2024
- FDA report date
- Sep 18, 2024
Frequently asked
- Was BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal) recalled?
- PREQUEL SKIN recalled BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal) in Aug 2024 — an FDA Class II recall (D-0657-2024) because Microbial contamination of non-sterile Products -. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal) recalled?
- Per the FDA enforcement record, the reason for recall D-0657-2024 was: Microbial contamination of non-sterile Products -
- Is a recalled BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal) are affected?
- Distributed: Distributed nationwide in USA and on line. The recall covers these lots — Lot: X4054A, Exp: 2/2026; X4136A, X4137A, X4138A, Exp: 5/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0657-2024.