Medications & Supplements/Topical Products

Teligent Pharma, Inc.: Clobetasol Propionate Ointment USP 0.05% Recalled Due to Potency Issues

Agency Publication Date: December 1, 2020

Summary

Teligent Pharma, Inc. is recalling 20,160 tubes of Clobetasol Propionate Ointment USP 0.05% (50g) because the product may be superpotent or subpotent. Testing revealed low and high assay results, meaning the medication may contain more or less of the active ingredient than specified. Consumers using this prescription topical steroid should contact their healthcare provider or pharmacist regarding the effectiveness and safety of their current supply.

Risk

The ointment was found to have inconsistent potency levels; superpotent batches may increase the risk of side effects like skin thinning or systemic absorption, while subpotent batches may not effectively treat the skin conditions for which they were prescribed.

What You Should Do

Locate your tube of Clobetasol Propionate Ointment USP 0.05% (50 grams) and check the packaging for identifying information.
Confirm if your product is affected by looking for Lot Number 12597 with an expiration date of 12/2020.
Verify the National Drug Code (NDC) 52565-039-60 is printed on the label.
If you have the affected lot, contact your healthcare provider or pharmacist for guidance on whether to continue use and to discuss a replacement prescription.
Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund.
Contact Teligent Pharma, Inc. at their Buena, New Jersey location for further instructions or questions regarding this recall.
For additional information, 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: Clobetasol Propionate Ointment USP 0.05% (50 grams)

Model:

NDC 52565-039-60

Recall #: D-0119-2021

Lot Numbers:

12597 (exp. date 12/2020)

Date Ranges: 12/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86714

Status: Resolved

Manufacturer: Teligent Pharma, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 20160 tubes

Distributed To: Nationwide

Agency Last Updated: December 8, 2020

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

Locate your tube of Clobetasol Propionate Ointment USP 0.05% (50 grams) and check the packaging for identifying information.

Confirm if your product is affected by looking for Lot Number 12597 with an expiration date of 12/2020.

Verify the National Drug Code (NDC) 52565-039-60 is printed on the label.

If you have the affected lot, contact your healthcare provider or pharmacist for guidance on whether to continue use and to discuss a replacement prescription.

Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund.

Contact Teligent Pharma, Inc. at their Buena, New Jersey location for further instructions or questions regarding this recall.

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