DrugAug 13, 2025
Direct Rx Duloxetine D/R, 30 mg, 30 Caps recall — FDA D-0568-2025
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class IIFDA: OngoingDirect Rx
Recall history in this database
Classification mix: Class II: 3.
DrugApr 23, 2025
Direct Rx CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle recall — FDA D-0364-2025
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class IIFDA: OngoingDirect Rx
DrugNov 13, 2024
Direct Rx Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg recall — FDA D-0041-2025
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class IIFDA: OngoingDirect Rx
Understanding this recall history
This page summarizes recall records in which the official source identifies Direct Rx as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.