Direct Rx Ibuprofen 800mg Tablets Recalled Due to Impurity Failures
Direct Rx recalls 800mg ibuprofen tablets (Motrin) that failed stability testing for impurities. Products with NDC codes 61919-0621-15 to 61919-0621-72 are affected. No remedy specified in official notice.
Recall notice
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Contact the company
What happened, in plain English
Direct Rx is recalling ibuprofen 800mg tablets (Motrin) that failed impurity tests during stability testing. This means the medication may contain harmful substances that could cause health risks if taken. Read more at govinfonow.com/recall/32565-direct-rx-ibuprofen-800mg-tablets-recalled-due-to-impurity-failures.
Source Summary by GovInfoNow · govinfonow.com/recall/32565-direct-rx-ibuprofen-800mg-tablets-recalled-due-to-impurity-failures · Updated August 17, 2026 · FDA enforcement record: FDA #D-0041-2025
Cite this page
“Direct Rx Ibuprofen 800mg Tablets Recalled Due to Impurity Failures.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32565-direct-rx-ibuprofen-800mg-tablets-recalled-due-to-impurity-failures. Based on FDA recall #D-0041-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0041-2025%22&limit=1).
Why it’s dangerous
The product failed impurity specifications during 18-month stability testing. This indicates the medication may contain harmful substances that could cause health issues when taken. The failure occurs in the manufacturing process, not during normal use.
Who’s affected
People who own or use Direct Rx ibuprofen 800mg tablets (Motrin) with the listed NDC codes are affected. Those taking the medication regularly are most at risk due to potential impurities.
How to tell if you have this one
Check the product label for 'Ibuprofen 800mg, Generic for: Motrin' and the NDC codes listed (61919-0621-15 to 61919-0621-72). Products distributed by Direct Rx in Dawsonville, GA are affected.
- Brand
Direct Rx- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC codes 61919-0621-15 to 61919-0621-72 on the packaging to identify affected tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0041-2025 (August 9, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0041-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.