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Direct Rx

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20205
20212
202210
202315
20241
20253
20261
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FDA Recall Ongoing 2026 recordClass II

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

by Direct Rx

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published
July 1, 2026
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,

by Direct Rx

Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Published
August 13, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30

by Direct Rx

Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Published
August 13, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

by Direct Rx

Reason
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
Published
April 23, 2025
Distribution
Physicians and medical facilities in 5 s…

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FDA Recall Ongoing Historical recordClass II

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).

by Direct Rx

Reason
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Published
November 13, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.

by Direct Rx

Reason
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Published
April 12, 2023
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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 only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.

by Direct Rx

Reason
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Published
April 12, 2023
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.

by Direct Rx

Reason
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Published
April 12, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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This page lists recalls that name Direct Rx as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.