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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Akorn, Inc.: Lidocaine Hydrochloride Jelly Recalled for Potential Metal Contamination

Agency Publication Date: September 24, 2019
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Summary

Akorn, Inc. is recalling 10,543 tubes of Lidocaine Hydrochloride Jelly USP, 2% (generic lidocaine), a sterile local anesthetic. The recall was initiated after metal particles were found on the filling line equipment during production, suggesting a risk that the medication could be contaminated. While no metal has been found inside the actual product tubes to date, this voluntary recall affects 30 mL tubes distributed nationwide and in Puerto Rico. Consumers should check their medicine cabinets for this specific product, particularly those from the affected lot number 9B21A.

Risk

Although no metal particles were detected within the product itself, the presence of metal debris on the filling line indicates a potential for foreign material to enter the sterile jelly. If contaminated product is used, it could cause irritation, injury, or localized infection at the site of application.

What You Should Do

  1. Check your medicine for Lidocaine Hydrochloride Jelly USP, 2% in 30 mL tubes with NDC 17478-711-30.
  2. Verify the lot number and expiration date on the tube or packaging; this recall specifically affects Lot 9B21A with an expiration date of 1/2022.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you have been using this specific lot of medication.
  4. Return any unused tubes from the affected lot to the pharmacy or place of purchase for a refund.
  5. Contact Akorn, Inc. at the address 1925 W Field Ct Ste 300, Lake Forest, Illinois, 60045-4862 for further instructions regarding the return process.
  6. For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and product refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Lidocaine Hydrochloride Jelly USP, 2% (30 mL tube)
Model:
NDC 17478-711-30
Recall #: D-1878-2019
Lot Numbers:
9B21A (Exp. 1/2022)
Date Ranges: Expiration date 1/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83721
Status: Resolved
Manufacturer: Akorn, Inc.
Sold By: Pharmacies; Healthcare providers
Manufactured In: United States
Units Affected: 10,543 tubes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.