Drug & Device Safety Atlas

FDA recall record · openFDA

Direct Rx

18 FDA recalls on record (2023–2025) — 18 drug. 7 still ongoing.

0
Class I (most serious)
18
Class II
0
Class III
7
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

cGMP deviations 11
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. 3
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. 2
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of th 1
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing. 1

Recalls

CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC Class II 2025-01-31 Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Ph Class II 2025-03-07 Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919 Class II 2025-03-07 Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Class II 2024-08-09 Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx Class II 2023-03-22 Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61 Class II 2023-03-13 Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: D Class II 2023-03-13 Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72 Class II 2023-03-22 Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Class II 2023-03-13 Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By Class II 2023-03-13 Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61 Class II 2023-03-13 Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61 Class II 2023-03-13 Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: D Class II 2023-03-13 Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC619 Class II 2023-03-13 Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Class II 2023-03-13 Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count Class II 2023-03-13 Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61 Class II 2023-03-13 Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC Class II 2023-03-22

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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