Medications & Supplements/Prescription Drugs

Bausch Health Companies, Inc.: Hydrocortisone Butyrate Cream Recalled Due to Subpotency

Agency Publication Date: October 26, 2020

Summary

Bausch Health Companies, Inc. is voluntarily recalling approximately 35,424 tubes of Hydrocortisone butyrate Cream, 0.1% (15-gram tubes) sold under the Oceanside Pharmaceuticals brand. This prescription topical medication was found to be subpotent, meaning it contains less of the active drug ingredient than required by safety standards. Because the medication is weaker than intended, it may not effectively treat the skin conditions for which it was prescribed. Consumers should contact their healthcare provider or pharmacist for guidance regarding continued treatment.

Risk

The drug is subpotent, which means it lacks the necessary strength to provide the full therapeutic effect. Using a subpotent medication can lead to ineffective treatment of inflammatory skin conditions, potentially causing symptoms to persist or worsen.

What You Should Do

Locate your 15-gram tube of Hydrocortisone butyrate Cream, 0.1% and check the packaging for NDC 68682-270-15.
Identify if your product is affected by checking the lot number and expiration date printed on the tube or carton against the following: Lot 18125C (Exp. 09/2020), Lot 19079B (Exp. 5/2021), Lot 19142B (Exp. 09/2021), or Lot 19167B (Exp. 10/2021).
Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if a replacement prescription is necessary.
Return any remaining unused product from the affected lots to the pharmacy where it was purchased for a refund.
Contact Bausch Health Companies, Inc. directly for further instructions regarding this recall.
For additional questions or to report adverse effects, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Hydrocortisone butyrate Cream, 0.1% (15-gram tubes)

Model:

NDC 68682-270-15

Recall #: D-0054-2021

Lot Numbers:

18125C (Exp. 09/2020)

19079B (Exp. 5/2021)

19142B (Exp. 09/2021)

19167B (Exp. 10/2021)

Date Ranges: Expiration Date 09/2020, Expiration Date 05/2021, Expiration Date 09/2021, Expiration Date 10/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86557

Status: Resolved

Manufacturer: Bausch Health Companies, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 35424 units

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 · 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.

Summary

What You Should Do

Locate your 15-gram tube of Hydrocortisone butyrate Cream, 0.1% and check the packaging for NDC 68682-270-15.

Identify if your product is affected by checking the lot number and expiration date printed on the tube or carton against the following: Lot 18125C (Exp. 09/2020), Lot 19079B (Exp. 5/2021), Lot 19142B (Exp. 09/2021), or Lot 19167B (Exp. 10/2021).

Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if a replacement prescription is necessary.

Return any remaining unused product from the affected lots to the pharmacy where it was purchased for a refund.

Contact Bausch Health Companies, Inc. directly for further instructions regarding this recall.

For additional questions or to report adverse effects, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.