CLASS II Drug recall · Reported 4 Nov 2020 · FDA Enforcement Report
Hydrocortisone butyrate Cream, 0.1% tubes recalled
Bausch Health Companies is recalling Hydrocortisone butyrate Cream, 0.1% tubes, distributed nationwide in the US. The recall was initiated on 13 Jul 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0054-2021
- FDA event ID
- 86557
- Recalling firm
- Bausch Health Companies, Bridgewater, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jul 2020
- FDA classified
- 26 Oct 2020
- Reported
- 4 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 13 Jul 2020 | Recall initiated by company | |
| 26 Oct 2020 | Classified by FDA | +105 days |
| 4 Nov 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
SUBPOTENT DRUG
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
SUBPOTENT DRUG
Which lots are affected?
Lot #: 18125C, Exp. Date 09/2020; 19079B, Exp. Date 5/2021; 19142B, Exp. Date 09/2021; 19167B, Exp. Date 10/2021
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bausch Health Companies
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|---|---|---|---|---|---|
| Drug | CLASS II | Omeprazole and Sodium Bicarbonate For Oral Suspension recalled | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS III | Phytonadione Tablets, 5 mg ablets recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS III | Mephyton (Phytonadione) recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS III | Mephyton (phytonadione) Tablets 5mg recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS III | Phytonadione Tablets 5mg recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
Other Hydrocortisone Butyrate recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocortisone Butyrate Lotion recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone Butyrate Lotion recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone Butyrate Lotion recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Hydrocortisone Butyrate Cream recalled by Valeant Pharmaceuticals | Valeant Pharmaceuticals International | Potency & Assay | Nationwide |