Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S
Lack of Assurance of Sterility
- Agency
- FDA Drug
- Recall date
- May 12, 2026
- Status
- Ongoing
- Company
- Spectra Medical Devices, Llc
1. What product was recalled?
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S
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.
Quantity: 210625 ampules
Code or lot text: Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
- LOT
- AE5032 & AE5039
- LOT
- AE5104
- LOT
- Exp 1/31/2027
- LOT
- Exp 3/31/2028
- LOT
- Exp 8/31/2028.
- LOT
- Lot#: AE4013
- NDC
- 65282-1605
- NDC
- 65282-1605-1
- RECALL-NUMBER
- D-0554-2026
- UPC
- 0365282160515
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Lack of Assurance of Sterility
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Drug source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.