Medications & Supplements/Topical Products

Oxalis Labs: Clobetasol Propionate Topical Solution Recalled for Leaking Containers

Agency Publication Date: February 14, 2019

Summary

Oxalis Labs is recalling 53,358 bottles of Clobetasol Propionate Topical Solution USP, 0.05% w/w, due to reports of defective containers that are leaking. This medication is a prescription-strength corticosteroid used to treat various skin conditions. The recall affects 50 mL bottles manufactured for Macleods Pharma USA and distributed to major suppliers across several states.

Risk

Leaking containers can lead to loss of the medication and potential skin contact with the solution for anyone handling the bottle. This may result in accidental exposure to the potent steroid medication or an insufficient dose for the patient using the product.

What You Should Do

Check your medication cabinet for 50 mL bottles of Clobetasol Propionate Topical Solution USP, 0.05% w/w, manufactured for Macleods Pharma USA.
Carefully inspect the bottle for the following Lot Numbers and expiration dates: PCA801A, PCA802A, or PCA803A (expiring 12/2019); and PCA804A, PCA805A, PCA806A, or PCA807A (expiring 04/2020).
Confirm the UPC code 33342032186 and NDC 33342-321-86 are printed on the product label.
If your bottle matches any of these lot numbers, contact your healthcare provider or pharmacist for guidance on how to safely manage your treatment.
Return any unused or leaking medication to the pharmacy where it was purchased for a refund and contact Oxalis Labs or Macleods Pharma USA for further instructions.
For additional questions or to report a problem, 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

Drug recall remedy for leaking containers

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

Affected Products

Product: Clobetasol Propionate Topical Solution USP, 0.05% w/w (50 mL bottle)

Model:

NDC 33342-321-86

UPC Codes:

33342032186

Lot Numbers:

PCA801A (Exp 12/2019)

PCA802A (Exp 12/2019)

PCA803A (Exp 12/2019)

PCA804A (Exp 04/2020)

PCA805A (Exp 04/2020)

PCA806A (Exp 04/2020)

PCA807A (Exp 04/2020)

Date Ranges: Expiration date 12/2019, Expiration date 04/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81914

Status: Resolved

Manufacturer: Oxalis Labs

Sold By: major distributors

Manufactured In: India

Units Affected: 53,358 bottles

Distributed To: Illinois, New York, Arkansas, Kentucky

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

Check your medication cabinet for 50 mL bottles of Clobetasol Propionate Topical Solution USP, 0.05% w/w, manufactured for Macleods Pharma USA.

Carefully inspect the bottle for the following Lot Numbers and expiration dates: PCA801A, PCA802A, or PCA803A (expiring 12/2019); and PCA804A, PCA805A, PCA806A, or PCA807A (expiring 04/2020).

Confirm the UPC code 33342032186 and NDC 33342-321-86 are printed on the product label.

If your bottle matches any of these lot numbers, contact your healthcare provider or pharmacist for guidance on how to safely manage your treatment.

Return any unused or leaking medication to the pharmacy where it was purchased for a refund and contact Oxalis Labs or Macleods Pharma USA for further instructions.

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

Affected Products

Product: Clobetasol Propionate Topical Solution USP, 0.05% w/w (50 mL bottle)

Model:

NDC 33342-321-86

UPC Codes:

33342032186

Lot Numbers:

PCA801A (Exp 12/2019)

PCA802A (Exp 12/2019)

PCA803A (Exp 12/2019)

PCA804A (Exp 04/2020)

PCA805A (Exp 04/2020)

PCA806A (Exp 04/2020)

PCA807A (Exp 04/2020)

Date Ranges: Expiration date 12/2019, Expiration date 04/2020