Lidocaine HCL 1% (10mg/mL) recall
FDA recall D-0363-2024 · initiated Feb 20, 2024
Denver Solutions, LLC DBA Leiters Health recalled Lidocaine HCL 1% (10mg/mL) in Feb 2024 — an FDA Class II recall (D-0363-2024) because Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 40,890 vials
Details
- Product
- Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
- Recalling company
- Denver Solutions, LLC DBA Leiters Health
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Feb 20, 2024
- FDA report date
- Mar 6, 2024
Frequently asked
- Was Lidocaine HCL 1% (10mg/mL) recalled?
- Denver Solutions, LLC DBA Leiters Health recalled Lidocaine HCL 1% (10mg/mL) in Feb 2024 — an FDA Class II recall (D-0363-2024) because Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lidocaine HCL 1% (10mg/mL) recalled?
- Per the FDA enforcement record, the reason for recall D-0363-2024 was: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Is a recalled Lidocaine HCL 1% (10mg/mL) 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 Lidocaine HCL 1% (10mg/mL) are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #:2331104, Exp:9-Mar-24; 2331137, Exp: 3-Mar-24; 2331196, Exp: 11-Mar-24; 2331264, Exp: 6-Apr-24; 2331282, Exp: 18-Apr-24; 2331464, Exp: 8-May-24; 2331481, Exp: 16-May-24; 2331500, Exp: 20-May-24.. 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-0363-2024.