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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/Topical Products

Teligent Pharma, Inc.: Lidocaine Ointment USP, 5% Recalled for Failed Viscosity Specifications

Agency Publication Date: August 31, 2021
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Summary

Teligent Pharma, Inc. is recalling 114,456 tubes of Lidocaine Ointment USP, 5%, a prescription topical anesthetic. The recall was initiated because routine testing determined that certain lots did not meet required thickness (viscosity) specifications. If the ointment is too thin, it may result in an inconsistent dosage or difficulty applying the medication properly to the skin. Consumers who have this medication should check their tubes immediately to see if they are part of the affected batches.

Risk

The failed viscosity means the product's consistency does not meet quality standards, which can lead to improper drug delivery or reduced effectiveness of the anesthetic. While this poses a low risk of serious injury, it can compromise the treatment's intended numbing effect.

What You Should Do

  1. Check the packaging of your Lidocaine Ointment USP, 5% (35.44 g tube) for NDC number 52565-008-14.
  2. Verify the lot numbers and expiration dates on the tube: look for Lot 15378 with expiration date 3/2023 or Lot 14418 with expiration date 10/2021.
  3. If your product matches these identifiers, contact your healthcare provider or pharmacist for guidance on how to obtain a replacement.
  4. Return any unused product from the affected lots to your pharmacy for a refund.
  5. Contact Teligent Pharma, Inc. at their Buena, New Jersey location for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact 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

Refund or replacement through healthcare provider/pharmacy

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

Affected Products

Product: Lidocaine Ointment USP, 5% Rx Only (Net Wt 35.44 g / 1 1/4 oz)
Model:
NDC 52565-008-14
Recall #: D-0785-2021
Lot Numbers:
15378 (Exp 3/2023)
14418 (Exp 10/2021)
Date Ranges: Exp 3/2023, Exp 10/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88382
Status: Resolved
Manufacturer: Teligent Pharma, Inc.
Sold By: pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 114,456 tubes
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.