Medications & Supplements/Topical Products

Direct Rx Diclofenac Sodium Topical Solution Recalled for Leaking Containers

Agency Publication Date: March 22, 2022

Summary

Direct Rx has voluntarily recalled 312 bottles of Diclofenac Sodium Topical Solution 1.5% (150 mL). The recall was issued because the bottles may leak, which can lead to product loss or contamination. This prescription medication was packaged by Direct Rx for SOLA Pharmaceuticals and distributed to pharmacies nationwide.

Risk

Leaking containers may result in an incorrect dosage being administered or the medication being exposed to environmental contaminants. No incidents or injuries have been reported to date in connection with this issue.

What You Should Do

This recall affects Diclofenac Sodium Topical Solution 1.5% (150 mL) bottles labeled with NDC 61919-675-05, lot number 24MA2010, and an expiration date of January 31, 2023.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Diclofenac Sodium Topical Solution 1.5% (150 mL)

Variants: 1.5% Strength, 150 mL Bottle, Topical Solution

Lot Numbers:

24MA2010 (Exp. 1/31/2023)

NDC:

61919-675-05

Packaged and Distributed by Direct Rx for SOLA Pharmaceuticals; Recall number D-0714-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89807

Status: Resolved

Manufacturer: Direct Rx

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 312 bottles

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

This recall affects Diclofenac Sodium Topical Solution 1.5% (150 mL) bottles labeled with NDC 61919-675-05, lot number 24MA2010, and an expiration date of January 31, 2023.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.