Reported Nov 13, 2024 · Ongoing
Ibuprofen 800mg, Generic for
Direct Rx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Direct Rx · 94 Worldwide Dr · Dawsonville, GA · 30534-6828
Is this the product you have?
Ibuprofen 800mg, Generic for
7 of 7 products
| # | Product as published |
|---|---|
| 1 | NDC 61919-0621-15 (15 count bottles) |
| 2 | NDC 61919-0621-30 (30 count bottles |
| 3 | NDC 61919-0621-40 (40 count bottles) |
| 4 | NDC 61919-0621-60 (60 count bottles) |
| 5 | NDC 61919-0621-90 (90 count bottles) |
| 6 | NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles) |
| 7 | NDC 61919-0621-72 (120 count bottles). |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 02FE2414, Exp 11/30/26. 2 18JU2407, Exp 11/30/26; 27JY2316, Exp 02/28/27; 13SE2317, 13OC2312, 23AU2307, Exp 03/31/27. 3 25SE2308, Exp 03/31/27. 4 29MA2313, 23MA2315, Exp 12/31/26; 25MY2304, Exp 01/31/27; 26JU2313, 27JY2314, Exp 02/28/27. 5 27SE2322, 30OC2304, 12OC2301, Exp 03/31/27. 6 11SE2322, 02FE2419, 23JA2405, 10JA2426, 17MY2416, 05DE2312, 24OC2321, 05FE2433, 20MA2418, 29NO2317, Exp 11/30/26. 7 31MA2308, Exp 12/31/26; 25SE2305, Exp 03/31/27. - Amount recalled
- 1410 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
This product could cause temporary or reversible health problems — stop using it.
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