Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Hydrocortisone butyrate Cream
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
SUBPOTENT DRUG
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15
Affected NDC
68682-0270-15
Compare with the code on your package — it is the most precise check available.
Drug: Hydrocortisone
- Recalling firm
- Bausch Health Companies, Inc.
- NDC code
- 68682-270-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0054-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydrocortisone recalls
See all
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class III · Low risk
Essential Calming Skin Gel
Subpotent Drug
Class III · Low risk
Skin Rehab
Subpotent Drug
Class III · Low risk
Remedy Gel
Subpotent Drug
Other recalls by Bausch Health Companies, Inc.
All 2020 recalls
Class II · Moderate risk
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1
Subpotent Drug: Out of specification for assay
Class III · Low risk
Phytonadione Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Mephyton (Phytonadione)
Failed Impurities/Degradation Specifications
Class III · Low risk
Phytonadione Tablets 5mg
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
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