Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%) recall
FDA recall D-0369-2026 · initiated Jan 20, 2026
ACME UNITED CORPORATION recalled Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%) in Jan 2026 — an FDA Class II recall (D-0369-2026) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- Product
- Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02
- Recalling company
- ACME UNITED CORPORATION
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jan 20, 2026
- FDA report date
- Mar 11, 2026
Frequently asked
- Was Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%) recalled?
- ACME UNITED CORPORATION recalled Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%) in Jan 2026 — an FDA Class II recall (D-0369-2026) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%) recalled?
- Per the FDA enforcement record, the reason for recall D-0369-2026 was: CGMP Deviations
- Is a recalled Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%) are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 52347-R, 52348-R, 52349-R, 52350-R, 52351-R, 52352-R, 53518, 53519, Exp. Date Mar 2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0369-2026.