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Verified · FDAClass II — Possible RiskMedications

Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only Recall 2026

LIDOCAINE HYDROCHLORIDEIssued May 12, 2026Updated Reviewed by the Recall Watch editorial team

LIDOCAINE HYDROCHLORIDE 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. — recalled per FDA on 5/12/2026. Reason: Lack of Assurance of Sterility.

Agency
FDA
Issued
May 12, 2026
Brand
LIDOCAINE HYDROCHLORIDE
Distribution
1 states
Lots affected
6
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued May 12, 2026 · Last synced Nov 1, 2026

What's recalled

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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Why it was recalled

Lack of Assurance of Sterility

Affected products & lot numbers
6 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot#: AE4013
Exp 1/31/2027
AE5032 & AE5039
Exp 3/31/2028
AE5104
Exp 8/31/2028.
Where was it sold
1 state

USA Nationwide

nationwide
Official noticefda.gov
More recalls like this
7 related — by brand, contaminant, and category

Frequently asked questions

Is the LIDOCAINE HYDROCHLORIDE recall still active?

Yes, this recall is currently active as of May 12, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot#: AE4013, Exp 1/31/2027, AE5032 & AE5039, Exp 3/31/2028, AE5104, Exp 8/31/2028.. Check the label on your product.

What should I do if I have the recalled LIDOCAINE HYDROCHLORIDE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.