Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Take action
Contact the company
📍Recalling firmBlaine Labs Inc11037 Lockport Pl · Santa Fe Springs, CA 90670-4634
✎ GovInfoNow plain-language explainer
Blaine Labs Inc has recalled RevitaDerm Wound Care Gel because FDA analysis found it contaminated with Bacillus cereus, a bacterium that can cause serious infections in open wounds. The recall covers specific lots distributed nationwide to doctors. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/35324-revitaderm-wound-care-gel-recall-bacillus-cereus-contamination.
“RevitaDerm Wound Care Gel Recall: Bacillus cereus Contamination.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35324-revitaderm-wound-care-gel-recall-bacillus-cereus-contamination. Based on FDA recall #D-0668-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0668-2022%22&limit=1).
Blaine Labs Inc recalled RevitaDerm Wound Care Gel due to microbial contamination, the FDA said on Jan. 25, 2022. The Food and Drug Administration announced the Class I recall under agency number D-0668-2022.
How to tell if you have it
Brand: RevitaDerm
Product: Wound Care Gel (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%
Packaging: 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)
Lot/Batch #: BL 2844
Expiration date: 2/19/2023
The hazard
FDA analysis found the non-sterile product to be contaminated with Bacillus cereus. The recall is classified as Class I, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Context
GovInfoNow's records show Blaine Labs Inc has one other recall on record since April 8, 2026: the Blaine Labs TERPENICOL Antifungal Solution Recall for CGMP Stability Testing Issues. Other recent recalls of similar products include Wisconsin Pharmacal MG217 Cream Recall (April 24, 2026), BD ChloraPrep Scrub Teal Recall (June 11, 2026), and Walgreens Saline Nasal Spray with Xylitol Recall (Nov. 12, 2025).
How to tell if you have this one
Check if you have RevitaDerm Wound Care Gel in 29.6 mL bottles (NDC 63347-120-02) or 88.7 mL tubes (NDC 63347-120-01). Verify the Lot/Batch number is BL 2844 and the expiration date is 2/19/2023.
Brand
RevitaDerm
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using the Product
Do not apply the recalled gel to any wounds due to the risk of bacterial infection.
Contact Your Doctor
Reach out to the prescribing physician or healthcare provider who supplied the product for further guidance on alternative treatments.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in 17 States to 45 doctors.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0668-2022 (January 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0668-2022 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.