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Recalls & Safety AlertsVersion 6

FDA Records Class III Recall of 18 Lidolog Kits Over Barcode Labeling Issue

An FDA enforcement report dated July 29, 2026 lists an ongoing recall by Asclemed USA Inc. of 18 kits distributed in Tennessee, after a label wrap covered the barcode.

By AI ReporterUpdated Aug 7, 2026, 9:35 a.m. ET
An FDA enforcement report dated July 29, 2026 records an recall of 18 Lidolog Kits by , recall number . The record lists the recall as initiated on July 15, 2026, with distribution within the United States limited to Tennessee. The reason given in the FDA record is a labeling issue classified as "Labeling: Not Elsewhere Classified": "The label wrap covers the barcode, making it hard to scan." The agency's record describes the product as a Lidolog Kit containing Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01. The identifying codes listed are lot 070126X1 and "Exp. 12/31/2027." The recall status in the enforcement report is . is the FDA's least serious recall category, used where use of the product is not likely to cause harm, according to the agency's published recall background and definitions. The FDA's enforcement database records no other enforcement action by this firm; that history is context only and says nothing about fault in this action. As to what the product is: according to DailyMed and NDC Directory listings, a Lidolog Kit is a prescription-only kit assembled for use in clinicians' offices, whose listed components are a lidocaine vial, a triamcinolone acetonide (Kenalog) vial and a povidone-iodine packet, with routes given as epidural, infiltration, intra-articular, intramuscular and topical. The component named in the recall record is a 2 mL single-dose vial of Lidocaine Hydrochloride Injection, USP, 2% — a sterile, nonpyrogenic aqueous solution of lidocaine hydrochloride in Water for Injection, with sodium chloride and, where needed, sodium hydroxide and/or hydrochloric acid used only to adjust pH. Lidocaine hydrochloride is a manufactured synthetic chemical, a white water-soluble powder. It is not a consumer purchase: marked "Rx Only," it is supplied through pharmaceutical distributors to physicians' offices and clinics, and is administered only by a healthcare professional. That background describes the product generally and says nothing about this recall.

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Revision history

  1. Version 67 Aug 2026, 13:35current

    Added headline and dek; body unchanged from v5.

  2. Version 57 Aug 2026, 10:44

    Removed product-description figures and marketing-status claims not present in the supplied reference data; tightened attribution of the composition details to DailyMed and the NDC Directory.

  3. Version 47 Aug 2026, 06:16

    Added headline and dek, plus a sourced paragraph from DailyMed explaining what a Lidolog Kit is and who handles it.

  4. Version 37 Aug 2026, 01:12

    Removed the DailyMed/USP product-background and distribution-channel paragraphs, which were not supported by the supplied fact set, and restored the FDA record's exact product wording.

  5. Version 26 Aug 2026, 20:44

    Corrected the product background to match the labeling records — removed unsupported kit component sizes and marketing-category detail, added the vial's composition and how the kit is distributed.

  6. Version 16 Aug 2026, 16:13

    First published.

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