FDA Drug recall D-0699-2026
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…
- FDA Drug
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of 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… by Blaine Labs, citing CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0699-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-08 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Blaine Labs |
| Distribution | US |
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,
Reason
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Identifiers
| ndc | 63347-120-01 |
|---|---|
| ndc | 63347-120-02 |
| code_info | 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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0699-2026%22
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