Medications & Supplements/Topical Products

Teligent Pharma, Inc.: Lidocaine Hydrochloride Topical Solution Recalled for High Potency

Agency Publication Date: September 15, 2021

Summary

Teligent Pharma, Inc. is recalling 32,544 bottles of Lidocaine Hydrochloride Topical Solution, USP, 4% (50 mL). This prescription-only medication is being recalled because it was found to be superpotent, meaning it contains a higher concentration of the active ingredient than specified. Patients should contact their healthcare provider or pharmacist regarding this recall and for guidance on their medication. Consumers can return any unused product to their pharmacy for a refund.

Risk

Using a superpotent lidocaine solution can lead to a higher-than-intended dose, which increases the risk of lidocaine toxicity. This can result in serious adverse health effects such as central nervous system reactions (like seizures or tremors) and cardiovascular issues.

What You Should Do

Check your medication cabinet for 50 mL glass bottles of Lidocaine Hydrochloride Topical Solution, USP, 4% with the Teligent Pharma Inc. label and NDC 52565-009-50.
Verify the specific batch by looking for lot number 14218 with an expiration date of 08/2022 printed on the bottle.
If you have the affected product, contact your healthcare provider or pharmacist immediately to discuss your treatment and potential health risks.
Return any unused or remaining product from lot 14218 to the pharmacy where you purchased it for a refund.
For further instructions or questions regarding the return process, contact the manufacturer, Teligent Pharma, Inc., at their Buena, New Jersey location.
For additional information, you may contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy 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 Topical Solution, USP, 4% (50 mL glass bottles)

Model:

NDC 52565-009-50

Recall #: D-0800-2021

Lot Numbers:

14218 (Exp. Date 08/2022)

Date Ranges: 08/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88454

Status: Active

Manufacturer: Teligent Pharma, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 32,544 glass bottles

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 · 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.

Summary

What You Should Do

Check your medication cabinet for 50 mL glass bottles of Lidocaine Hydrochloride Topical Solution, USP, 4% with the Teligent Pharma Inc. label and NDC 52565-009-50.

Verify the specific batch by looking for lot number 14218 with an expiration date of 08/2022 printed on the bottle.

If you have the affected product, contact your healthcare provider or pharmacist immediately to discuss your treatment and potential health risks.

Return any unused or remaining product from lot 14218 to the pharmacy where you purchased it for a refund.

For further instructions or questions regarding the return process, contact the manufacturer, Teligent Pharma, Inc., at their Buena, New Jersey location.

For additional information, you may contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.