Revitaderm Wound Care recall
FDA recall D-0699-2026 · initiated Apr 8, 2026
Blaine Labs Inc recalled Revitaderm Wound Care in Apr 2026 — an FDA Class II recall (D-0699-2026) because CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 5,555 bottles and tubes
Details
- Product
- Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,
- Recalling company
- Blaine Labs Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 8, 2026
- FDA report date
- Jul 8, 2026
Frequently asked
- Was Revitaderm Wound Care recalled?
- Blaine Labs Inc recalled Revitaderm Wound Care in Apr 2026 — an FDA Class II recall (D-0699-2026) because CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Revitaderm Wound Care recalled?
- Per the FDA enforcement record, the reason for recall D-0699-2026 was: CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
- Is a recalled Revitaderm Wound Care 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 Revitaderm Wound Care are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27. 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-0699-2026.