Spectra Medical Devices, Llc recalls Lidocaine HCl Injection USP
- Recalling company
- Spectra Medical Devices, Llc
- 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.
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 12, 2026
- Reported
- Jun 10, 2026
- Distribution
- USA Nationwide
- Status
- Ongoing
- Quantity
- 210625 ampules
- Lot / codes
- Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
- Company location
- Wilmington, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0554-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0554-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.