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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/Topical Products

Teligent Pharma Betamethasone Dipropionate Lotion Recalled for Stability Issues

Agency Publication Date: December 28, 2021
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Summary

Teligent Pharma, Inc. has recalled approximately 3,792 bottles of Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), a prescription topical medication. The recall was initiated because routine testing showed the product lot failed stability specifications for the active ingredient particle test. No injuries or incidents related to this issue have been reported.

Risk

The failure to meet stability specifications could mean the medication is not as effective or consistent as required for treatment. While no injuries have been reported, consumers should contact their healthcare provider if they have concerns about their treatment.

What You Should Do

  1. This recall affects one lot of Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), sold in 30 mL (29 g) bottles with NDC 52565-023-29.
  2. Check your medication bottle for lot number 16569 with an expiration date of 9/2022.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Teligent Pharma, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Betamethasone Dipropionate Lotion USP, 0.05% (Augmented)
Variants: 0.05% (Augmented), 30 mL bottle (29 g)
Lot Numbers:
16569 (Exp 9/2022)
NDC:
52565-023-29

Recall #: D-0297-2022; Rx Only

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88550
Status: Resolved
Manufacturer: Teligent Pharma, Inc.
Sold By: pharmacies
Manufactured In: United States
Units Affected: 3,792 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 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.