Direct Rx: Drug Recall
Recall #D-0041-2025 · 08/09/2024
Class II: Risk
Recall Details
- Recall Number
- D-0041-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Direct Rx
- Status
- Ongoing
- Date Initiated
- 08/09/2024
- Location
- Dawsonville, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1410 bottles
Reason for Recall
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Product Description
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).
Distribution Pattern
Nationwide in the US
Other Recalls by Direct Rx
- Class II: Risk 03/07/2025
- Class II: Risk 03/07/2025
- Class II: Risk 01/31/2025
- Class II: Risk 03/22/2023
- Class II: Risk 03/22/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.