Lower risk Drug recall · FDA · Published July 13, 2020

Bausch Health Hydrocortisone Cream Recall: Subpotent Drug Risk

Bausch Health recalls hydrocortisone butyrate cream 0.1% 15g tubes (Rx only) due to subpotent drug risk. This means the medication may not provide intended treatment. Affected lots manufactured for Oceanside Pharmaceuticals.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0054-2021Drug Bausch Health ›

Lower-risk recall

SUBPOTENT DRUG

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Contact the company

Recalling firmBausch Health Companies, Inc.400 Somerset Corporate Blvd · Bridgewater, NJ 08807-2867

✎ GovInfoNow plain-language explainer

Bausch Health is recalling hydrocortisone butyrate cream 0.1% 15-gram tubes (prescription only) because the product may be subpotent. This means the medication might not work as intended for the intended condition. People with a prescription for this cream should check if they have the affected lots. Read more at govinfonow.com/recall/36934-bausch-health-hydrocortisone-cream-recall-subpotent-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36934-bausch-health-hydrocortisone-cream-recall-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0054-2021

Cite this page

“Bausch Health Hydrocortisone Cream Recall: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36934-bausch-health-hydrocortisone-cream-recall-subpotent-drug-risk. Based on FDA recall #D-0054-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0054-2021%22&limit=1).

The FDA announced on July 13, 2020, that Bausch Health Companies, Inc. is recalling Hydrocortisone butyrate Cream, 0.1%, due to subpotent drug risks. The recall affects 35,424 units distributed nationwide.

How to tell if you have it

Brand: Bausch Health
Product: Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only
NDC: 68682-270-15
Lot #: 18125C, Exp. Date 09/2020; 19079B, Exp. Date 5/2021; 19142B, Exp. Date 09/2021; 19167B, Exp. Date 10/2021
Quantity: 35,424 units

The hazard

The recalled Hydrocortisone butyrate Cream is subpotent, meaning it may not contain the labeled amount of active ingredient. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Bausch Health Companies, Inc. has 3 other recalls on record since 2021-01-07. Other recent recalls of similar products include CoValence Laboratories Remedy Gel Hydrocortisone 1% Recall (2026-03-18), CoValence Laboratories Skin Rehab Gel Recall (2026-03-18) and CoValence Laboratories Essential Calming Skin Gel Hydrocortisone 1% Recall (2026-03-18).

How to tell if you have this one

Check for hydrocortisone butyrate cream 0.1% 15-gram tubes with NDC 68682-270-15, lot numbers 18125C (exp 09/2020), 19079B (exp 05/2021), 19142B (exp 09/2021), or 19167B (exp 10/2021).

Brand
Bausch Health
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify if your cream has the NDC 68682-270-15 and the listed lot numbers.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Jul 13, 2020Firm started the recall
Oct 26, 2020FDA classified it Class II
Nov 4, 2020Published in FDA’s Enforcement Report
Mar 3, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/36934-bausch-health-hydrocortisone-cream-recall-subpotent-drug-risk">Bausch Health Hydrocortisone Cream Recall: Subpotent Drug Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0054-2021 (July 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0054-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.