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Class II: temporary or reversible health riskOngoing

Spectra Medical Devices Lidocaine HCl Injection Recall

Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spe…

Spectra Medical Devices, Llc · Wilmington, MA

Risk level
Class II
Reported by FDA
Jun 10, 2026
Recall ID
D-0554-2026
Check your lot numberHow we source this data

Summary

Spectra Medical Devices recalled Lidocaine HCl Injection starting May 12, 2026. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0554-2026 on Jun 10, 2026. Reason: Lack of Assurance of Sterility. Status: Ongoing.

Why it was recalled

Lack of Assurance of Sterility

Product 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.

Lot numbers, UPCs & expiration codes

Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0554-2026
Classification
Class II
Status
Ongoing
Recall initiated
May 12, 2026
FDA report date
Jun 10, 2026
Quantity
210625 ampules
Recall type
Voluntary: Firm initiated
Recalling firm
Spectra Medical Devices, Llc

Original FDA data

Every field from FDA enforcement report D-0554-2026, exactly as published.

Show all FDA fields
City
Wilmington
State
MA
Status
Ongoing
Country
United States
Event ID
98976
Address
299 Ballardvale St
Address (line 2)
Ste 1
Code information
Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
Postal code
01887-1066
Report date
Jun 10, 2026
Product type
Drugs
Recall number
D-0554-2026
Classification
Class II
Recalling firm
Spectra Medical Devices, Llc
Product quantity
210625 ampules
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product 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.
Distribution pattern
USA Nationwide
Recall initiation date
May 12, 2026
Initial firm notification
Letter
Center classification date
Jun 2, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0554-2026, published Jun 10, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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