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: 12.
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
DrugApr 12, 2023
Direct Rx Alprazolam C-IV, 1 mg recall — FDA D-0508-2023
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class IIFDA: OngoingDirect Rx
DrugSep 21, 2022
Triamcinolone Acetonide cream, 0.1%, 80 g tube recall — FDA D-1535-2022
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class IIFDA: CompletedDirect Rx
DrugJun 8, 2022
Losartan Pot./HCTZ 100/12.5 mg Packaged and recall — FDA D-0971-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIFDA: TerminatedDirect Rx
DrugJun 1, 2022
Direct Rx Zonisamide Capsules USP, 100 mg, 90-count bottle recall — FDA D-0888-2022
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class IIFDA: TerminatedDirect Rx
DrugMar 16, 2022
Direct Rx Alprazolam C-IV 1 mg 60-count bottles recall — FDA D-0650-2022
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class IIFDA: TerminatedDirect Rx
DrugMar 16, 2022
Direct Rx Alprazolam C-IV 2 mg, 60-count bottles recall — FDA D-0651-2022
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class IIFDA: TerminatedDirect Rx
DrugMar 24, 2021
Direct Rx Nortriptyline HCL capsules, 10 mg recall — FDA D-0300-2021
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally…
Class IIFDA: TerminatedDirect Rx
DrugOct 14, 2020
Direct Rx Losartan Potassium 100 mg, 30 Tabs bottles recall — FDA D-0018-2021
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Class IIFDA: TerminatedDirect Rx
DrugOct 7, 2020
Direct Rx Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and recall — FDA D-0032-2021
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Class IIFDA: TerminatedDirect 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.