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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.: Betamethasone Dipropionate Ointment Recalled for Impurity Specification Failure

Agency Publication Date: June 14, 2019
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Summary

Teligent Pharma, Inc. is recalling 9,360 tubes of Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), including both 15-gram and 50-gram tubes. This recall was issued because the medication failed to meet quality standards for impurities and degradation during testing. If you are using this prescription skin ointment, it may contain degradation products that could affect the medication's quality or performance.

Risk

The product failed to meet stability specifications for impurities and degradation, which means the chemical composition of the ointment has changed over time. While the risk is considered low, using degraded medication may result in reduced effectiveness or unexpected skin reactions.

What You Should Do

  1. Check your ointment tube and packaging to see if it is Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) in either the 15-gram (NDC 52565-019-15) or 50-gram (NDC 52565-019-51) size.
  2. Verify the lot number and expiration date on the crimp of the tube or the side of the carton; this recall specifically affects Lot 11852 with an expiration date of 08/2020.
  3. Contact your healthcare provider or pharmacist for guidance regarding your treatment if you have been using the affected ointment.
  4. Return any unused product from the affected lot to your pharmacy for a refund and contact Teligent Pharma, Inc. for further instructions.
  5. For additional information, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) (15 gram)
Model:
NDC 52565-019-15
Lot Numbers:
11852 (Exp 08/2020)
Date Ranges: 08/2020
Product: Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) (50 gram)
Model:
NDC 52565-019-51
Lot Numbers:
11852 (Exp 08/2020)
Date Ranges: 08/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82983
Status: Resolved
Manufacturer: Teligent Pharma, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 9360 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.