FDA-Drug2026-03-11Class IIPROCESSING DEFECT
Dynarex BZK Antiseptic Towelettes recalled for manufacturing quality deviations
What this means
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.
- 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
The agency's original wording
Hazard
CGMP Deviations
Intended for
All ages
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
N/A
Manufactured in
1 Waterview Dr Ste 200, N/A, Shelton, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0375-2026Want us to check the next one for you?
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