Lidocaine HCl Injection recall
FDA recall D-0636-2024 · initiated Aug 15, 2024
Fagron Compounding Services recalled Lidocaine HCl Injection in Aug 2024 — an FDA Class II recall (D-0636-2024) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
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.
Details
- Product
- Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.
- Recalling company
- Fagron Compounding Services
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Aug 15, 2024
- FDA report date
- Aug 28, 2024
Frequently asked
- Was Lidocaine HCl Injection recalled?
- Fagron Compounding Services recalled Lidocaine HCl Injection in Aug 2024 — an FDA Class II recall (D-0636-2024) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lidocaine HCl Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0636-2024 was: Lack of Assurance of Sterility
- Is a recalled Lidocaine HCl Injection 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 Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot#: C274-000037397, C274-000037398, C274-000037399, C274-000037400, Exp. Date 10/14/2024.. 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-0636-2024.