Lidocaine HCl Injection USP recall
FDA recall D-0554-2026 · initiated May 12, 2026
Spectra Medical Devices, Llc recalled Lidocaine HCl Injection USP in May 2026 — an FDA Class II recall (D-0554-2026) 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.
Quantity recalled: 210625 ampules
Details
- Product
- Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.
- Recalling company
- Spectra Medical Devices, Llc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- May 12, 2026
- FDA report date
- Jun 10, 2026
Frequently asked
- Was Lidocaine HCl Injection USP recalled?
- Spectra Medical Devices, Llc recalled Lidocaine HCl Injection USP in May 2026 — an FDA Class II recall (D-0554-2026) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lidocaine HCl Injection USP recalled?
- Per the FDA enforcement record, the reason for recall D-0554-2026 was: Lack of Assurance of Sterility
- Is a recalled Lidocaine HCl Injection USP 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 USP are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.. 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-0554-2026.