Lower risk Drug recall · FDA · Published December 7, 2021

Direct Rx Diclofenac Sodium Topical Solution 150mL Leaking Containers

Direct Rx recalls 150mL Diclofenac Sodium Topical Solution 1.5% due to leaking containers. This could lead to medication exposure risks.

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

🇺🇸 FDA recall #D-0714-2022Drug Direct Rx ›

Lower-risk recall

Defective Container: Leaking containers.

Take action

Contact the company

Recalling firmDirect Rx94 Worldwide Dr · Dawsonville, GA 30534-6828

✎ GovInfoNow plain-language explainer

Direct Rx is recalling 150mL Diclofenac Sodium Topical Solution 1.5% products because the containers may leak. Leaking containers could expose users to medication, potentially causing skin irritation or other issues. Read more at govinfonow.com/recall/35425-direct-rx-diclofenac-sodium-topical-solution-150ml-leaking-containers.

Source Summary by GovInfoNow · govinfonow.com/recall/35425-direct-rx-diclofenac-sodium-topical-solution-150ml-leaking-containers · Updated August 18, 2026 · FDA enforcement record: FDA #D-0714-2022

Cite this page

“Direct Rx Diclofenac Sodium Topical Solution 150mL Leaking Containers.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35425-direct-rx-diclofenac-sodium-topical-solution-150ml-leaking-containers. Based on FDA recall #D-0714-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0714-2022%22&limit=1).

The FDA announced on 2021-12-07 that Direct Rx is recalling Diclofenac Sodium Topical Solution due to leaking containers. Owners should contact the company for a refund.

How to tell if you have it

Brand: Direct Rx
Product: Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only
NDC: 61919-675-05
Lot #: 24MA2010
Expiration: 1/31/2023
Quantity: 312 bottles

The hazard

The recall involves defective containers that may leak. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Direct Rx has had 19 other recalls since 2019-03-12. Recent similar recalls include PureLife Benzoic Anesthetic Gel (2026-05-21), Cipla Diclofenac Gel (2025-12-22), and Teva Testosterone Gel 1% (2025-11-07).

How to tell if you have this one

Check for the product name 'Diclofenac Sodium Topical Solution 1.5%', 150mL size, and the lot number 24MA2010 with expiration date 1/31/2023. The product is only available by prescription.

Brand
Direct Rx
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot number 24MA2010 and expiration date 1/31/2023 on the container.

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 22 months after the firm started it.

Dec 7, 2021Firm started the recall
Mar 22, 2022FDA classified it Class II
Mar 30, 2022Published in FDA’s Enforcement Report
Oct 5, 2023FDA terminated the recall

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

Similar recalls

Other Direct Rx recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/35425-direct-rx-diclofenac-sodium-topical-solution-150ml-leaking-containers">Direct Rx Diclofenac Sodium Topical Solution 150mL Leaking Containers (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-0714-2022 (December 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0714-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.