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Asclemed: Multiple Lidocaine Hcl Injections
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DRUG RECALLMODERATE

Asclemed: Multiple Lidocaine Hcl Injections

Asclemed recalls Accucaine kits and Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL ampules due to lack of sterility assurance.

What to do

Do not use the recalled Accucaine kits or Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampules. Contact Asclemed USA Inc. for instructions on returning the product and obtaining a refund or replacement.

Recalled
Listed
Updated
Recall No.
D-0658-2026
Agency
FDA
Firm
Asclemed USA Inc.
Recall ID
99204
Status
ONGOING

Why it was recalled

Asclemed USA Inc. is recalling Accucaine kits containing Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampules, due to a lack of assurance of sterility. The recall affects the Accucaine kit and the Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Strength: 10 mg

ProductLot codeNDC / UPCRecall #
Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, 010626X3, 041326X4, 2026NDC 76420-715-01D-0658-2026
Lidocaine HCl Injection USP, 1% (AE3102, 031926L01, 032026A01, 2026NDC 85766-187-01D-0659-2026

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Sterility Failure recalls

Other recent recalls from Asclemed USA Inc.

All recalls from Asclemed USA Inc.

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification