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FDAClass II · Drug · Recalled June 10, 2026
Lidocaine HCl Injection USP recall — Spectra Medical Devices, Llc
Hazard: Lack of Assurance of Sterility
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- D-0554-2026
- Brand
- Spectra Medical Devices
- Classification
- Class II
- Units affected
- 210625 ampules
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
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.
Affected products
Companies & origin
- Recalling firm location
- Wilmington, MA, United States
- Firm address
- 299 Ballardvale St, Ste 1, 01887-1066
Identifying details (verbatim from the notice)
- Product codes / lots
- Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
- Distribution
- USA Nationwide
- Firm notified the public via
- Letter
- FDA event ID
- 98976
- Recall initiated
- May 12, 2026
- FDA classified
- June 2, 2026
- FDA report date
- June 10, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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