Dynarex BZK antiseptic towelettes recalled for CGMP deviations
Dynarex BZK Antiseptic Towelettes have been recalled because the manufacturer did not follow required quality and safety standards during production. The FDA identified manufacturing practice deviations that could affect product safety or effectiveness. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Stop using affected lots: 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352 (exp. Mar 2027) and 53518 (exp. Jun 2027)
- Check the lot number on your product package
- If you have an affected lot, do not use it and contact your supplier for a replacement or refund
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 21 products — see all of them.
Details
- Units affected
- N/A
- Illnesses reported
- None reported
- Manufactured in
- 1 Waterview Dr Ste 200, N/A, Shelton, CT, United States
- Classification
- Class II
- Recall number
- D-0375-2026
In the FDA's words
- Description
- Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01 CGMP Deviations Lot #: 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352, Exp. Date Mar 2027; 53518, Exp. Date Jun 2027. Distribution: Nationwide within the United States Affected quantity: N/A
- Hazard
- CGMP Deviations
21 products in this recall
First Aid Only and Med-Nap BZK wipes recalled for manufacturing deviations
Acme United Corporation is recalling 21 antiseptic and hand sanitizing towelette and wipe products nationwide for manufacturing (CGMP) deviations, a Class II classification. The products are sold under names including First Aid Only, Med-Nap, Dukal, Dynarex, Piedmont Sanitizing, Max Packaging, Savannah, Medi-First, Wipes Plus, WP WipesPlus, Green Guard, and Children's Healthcare of Atlanta, among others. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04D-0358-2026 · 212,607,900 containers
- First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.D-0359-2026 · N/A
- Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-…D-0360-2026 · N/A
- First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in U…D-0361-2026 · N/A
- 1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flo…D-0362-2026 · N/A
- Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01D-0363-2026 · N/A
- Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02D-0364-2026 · N/A
- Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33.D-0365-2026 · N/A
- Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481,…D-0366-2026 · N/A
- BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02.D-0367-2026 · N/A
- Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma Cit…D-0368-2026 · N/A
- Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orange…D-0369-2026 · N/A
- Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.D-0370-2026 · N/A
- Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC…D-0371-2026 · N/A
- WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.D-0372-2026 · N/A
- Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00D-0373-2026 · N/A
- Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73D-0374-2026 · N/A
- Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY… (this page)D-0375-2026 · N/A
- Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangebur…D-0376-2026 · N/A
- Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery B…D-0377-2026 · N/A
- Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.D-0378-2026 · N/A