Medications & Supplements/Topical Products

Ingenus Pharmaceuticals Llc: Diclofenac Sodium Topical Solution Recalled for Leaking Bottles

Agency Publication Date: March 25, 2019

Summary

Ingenus Pharmaceuticals is recalling approximately 29,435 bottles of Diclofenac Sodium Topical Solution (1.5% w/w), a prescription anti-inflammatory medication used for osteoarthritis. The recall was issued after the manufacturer discovered that the 5 FL. OZ. (150 mL) bottles were leaking when stored horizontally and received quality complaints from customers regarding the defective containers. This nationwide recall affects multiple lots of the medication that were distributed throughout the United States and Puerto Rico.

Risk

Leaking bottles can lead to a loss of product, potential skin exposure to the medication for those handling the containers, and may compromise the integrity and measured dosage of the solution.

What You Should Do

Check your prescription bottle to see if it is Diclofenac Sodium Topical Solution, 1.5% w/w in a 5 FL. OZ. (150 mL) size with NDC 50742-308-05.
Verify the lot number and expiration date on the bottle. This recall affects lot 31804 (Exp 11/2019); lots 31911 and 31917 (Exp 02/2020); lots 32067, 32072, and 32084 (Exp 06/2020); and lot 32248 (Exp 10/2020).
Contact your healthcare provider or pharmacist immediately for guidance if you possess any of the affected lots and to discuss alternative treatment options.
Return any unused product to the pharmacy where you purchased it for a refund and contact Ingenus Pharmaceuticals for further instructions.
For additional questions, 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

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

Affected Products

Product: Diclofenac Sodium Topical Solution, 1.5% w/w (5 FL. OZ. / 150 mL)

Model:

NDC 50742-308-05

Lot Numbers:

31804 (Exp 11/2019)

31911 (Exp 02/2020)

31917 (Exp 02/2020)

32067 (Exp 06/2020)

32072 (Exp 06/2020)

32084 (Exp 06/2020)

32248 (Exp 10/2020)

Date Ranges: Exp 11/2019, Exp 02/2020, Exp 06/2020, Exp 10/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82401

Status: Resolved

Manufacturer: Ingenus Pharmaceuticals Llc

Sold By: pharmacies

Manufactured In: United States

Units Affected: 29,435 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

Check your prescription bottle to see if it is Diclofenac Sodium Topical Solution, 1.5% w/w in a 5 FL. OZ. (150 mL) size with NDC 50742-308-05.

Verify the lot number and expiration date on the bottle. This recall affects lot 31804 (Exp 11/2019); lots 31911 and 31917 (Exp 02/2020); lots 32067, 32072, and 32084 (Exp 06/2020); and lot 32248 (Exp 10/2020).

Contact your healthcare provider or pharmacist immediately for guidance if you possess any of the affected lots and to discuss alternative treatment options.

Return any unused product to the pharmacy where you purchased it for a refund and contact Ingenus Pharmaceuticals for further instructions.

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

Affected Products

Product: Diclofenac Sodium Topical Solution, 1.5% w/w (5 FL. OZ. / 150 mL)

Model:

NDC 50742-308-05

Lot Numbers:

31804 (Exp 11/2019)

31911 (Exp 02/2020)

31917 (Exp 02/2020)

32067 (Exp 06/2020)

32072 (Exp 06/2020)

32084 (Exp 06/2020)

32248 (Exp 10/2020)

Date Ranges: Exp 11/2019, Exp 02/2020, Exp 06/2020, Exp 10/2020