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.
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
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.
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.
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.
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.
Look for the NDC codes 61919-0621-15 to 61919-0621-72 on the packaging to identify affected tablets.
The product failed impurity specifications during 18-month stability testing, meaning it may contain harmful substances.
The official notice does not specify a remedy, so contact Direct Rx for guidance.
Ibuprofen 800mg tablets (Motrin) with NDC codes 61919-0621-15 to 61919-0621-72 are affected.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0041-2025 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0041-2025 from Direct Rx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
