Reported Mar 30, 2022 · Terminated

Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton…

Teligent Pharma, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teligent Pharma, Inc. · 105 Lincoln Avenue · Buena, NJ · 08310

Is this the product you have?

  • Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only
  • Manufactured forSOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04
Lot codes and dates
  • Batch
    • 16896
    • 16897 Exp. 5/31/2023
Amount recalled
6874 bottles

This recall covers 37 products

The agency filed one notice per product. You are reading one of them; the other 36 are below.

24 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 17, 2024 · Data as of Sep 19, 7:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.