Revitaderm Wound Care Gel
FDA Recall NDC 63347-120
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Revitaderm Wound Care (NDC 63347-120). A significant event, classified as Class II, was initiated on Apr 08, 2026 by Blaine Labs Inc.. The reported reason for this action was: "CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
April 2026 Class II Recall: CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Recall Number
Class II Ongoing
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Apr 08, 2026
Jul 08, 2026
5,555 bottles and tubes
Recall Profile & Regulatory Data
Event ID
98731
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Blaine Labs Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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,
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
63347-120-01Product
63347-120-02Product
January 2022 Class I Recall: Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Recall Number
Class I Terminated
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Jan 25, 2022
Mar 30, 2022
1119 (1 oz.) bottles/ 772 (3 oz.) tubes
Recall Profile & Regulatory Data
Event ID
89481
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Blaine Labs Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in 17 States to 45 doctors.
Termination Date
Aug 01, 2022
Product Description
REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670
Batch or Lot Expiration Information
Lot# Lot/
Lot# : BL 2844, Expiration date 2/19/2023
Affected Packages Involved in this Recall
63347-120-01Product
63347-120-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
