drugs MODERATE Updated 2026-06-10

Spectra Medical Devices, Llc recalls Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, R

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Recalled 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.

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Hazard / Issue

Lack of Assurance of Sterility

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.

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