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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Hi-Tech Lidocaine Oral Solution Recalled Due to Low Viscosity

Agency Publication Date: May 5, 2022
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Summary

Akorn, Inc. has recalled 66,744 bottles of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% manufactured by Hi-Tech Pharmacal Co., Inc. The recall was initiated because the product was found to be too thin (below viscosity specifications). If the medication is not thick enough, it may not coat the mouth or throat as intended, which could lead to improper dosing or reduced effectiveness. No incidents or injuries have been reported to date.

Risk

The product's low thickness may prevent it from correctly adhering to the mouth and throat, potentially causing it to be swallowed too quickly and leading to ineffective treatment or dosing issues.

What You Should Do

  1. This recall affects Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% sold in 100 mL bottles manufactured by Hi-Tech Pharmacal Co., Inc.
  2. Check your medication bottle for NDC 50383-775-04 and lot number 370978 with an expiration date of 9/30/2022.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Akorn, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% (100 mL)by Hi-Tech Pharmacal Co., Inc.
Variants: 100 mL bottle, Viscous 2%, Rx only
Lot Numbers:
370978 (Exp 9/30/2022)
NDC:
50383-775-04

Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89993
Status: Resolved
Manufacturer: Akorn, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 66,744 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.