FDA DrugsClass II
Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case...
Published: March 11, 2026Recall ID: D-0360-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations
Product Description & Identification
Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1
Additional Source Details
| Field | Value |
|---|---|
| City | Shelton |
| State | CT |
| Openfda › Unii | F5UM2KM3W7 |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 1038558 |
| Openfda › Spl id | 3503a09f-812f-6d94-e063-6294a90aa5da |
| Openfda › Brand name | BZK TOWELETTE |
| Openfda › Spl set id | e37022d4-3d72-4d84-bddd-6b304fa0291e |
| Openfda › Package ndc › 1 | 65517-0004-1 |
| Openfda › Package ndc › 2 | 65517-0004-2 |
| Openfda › Product ndc | 65517-0004 |
| Openfda › Generic name | BENZALKONIUM CHLORIDE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | BENZALKONIUM CHLORIDE |
| Openfda › Manufacturer name | Dukal LLC |
| Openfda › Application number | M003 |
| Openfda › Is original packager | true |
| Event id | 98291 |
| Address 1 | 1 Waterview Dr Ste 200 |
| Address 2 | N/A |
| Code info | Lot #: MN31621, Exp. Date Oct 2026; MN14522, MN15522, Exp. Date Apr 2027; MN28122, MN31522, Exp. Date Sept 2027; MN04223, MN06023, Exp. Date Feb 2028; MN17223, Exp. Date May 2028; MN25123, Exp Date Aug 2028; MN33123, MN33523, Exp. Date Nov 2028. |
| Postal code | 06484-4368 |
| Report date | 20260311 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | CGMP Deviations |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260120 |
| Initial firm notification | Letter |
| Center classification date | 20260302 |
Overview
- Recalling FirmACME UNITED CORPORATION
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States