Reported May 11, 2022 · Terminated

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech…

Akorn, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Akorn, Inc. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862

Is this the product you have?

  • Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04
Lot codes and dates
    • Lot #: 370978
    • Exp 9/30/2022
Amount recalled
66,744 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed viscosity specification - product was below specificcation

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 28, 2023 · Data as of Sep 19, 6:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.