The Recall Desk

Manufacturer

Direct Rx

37 recalls in our database name Direct Rx as the manufacturing or recalling firm.

What the numbers show

Total
37
Critical
0
Severe
5
Most recent
2026-07-01

Of the 37 recalls from Direct Rx we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (14%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 37

  • ModerateFDA (Drugs)·D-0617-2026·2026-07-01

    Duloxetine 30 mg capsules recalled for impurity above FDA limits

    Direct Rx is recalling Duloxetine D/R 30 mg capsules (also sold as Cymbalta) distributed nationwide because the drug contains N-nitroso-duloxetine impurity above FDA-recommended interim limits.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0568-2025·2025-08-13

    Direct Rx duloxetine 30 mg capsules exceed the interim nitrosamine limit

    Duloxetine Delayed-Release 30 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 875 bottles affected.

    Product
    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,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0567-2025·2025-08-13

    Duloxetine delayed-release capsules exceed the interim nitrosamine impurity limit

    Duloxetine Delayed-Release 20 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 16 bottles affected.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0364-2025·2025-04-23

    Ciprofloxacin Ophthalmic Solution Recalled for Defective Container Cap

    Direct Rx is recalling Ciprofloxacin Ophthalmic Solution 0.3% because the cap spike may lodge in the bottle nozzle, preventing the medication from being dispensed.

    Product
    CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
    Category
    Drug
    Distribution
    5 states
  • HighFDA (Drugs)·D-0041-2025·2024-11-13

    Generic Ibuprofen 800mg Recalled Due to Failed Impurity and Degradation Specifications

    Direct Rx is recalling 1,410 bottles of Ibuprofen 800mg tablets distributed nationwide due to failed impurity specifications discovered during 18-month stability testing.

    Product
    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 cou
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0507-2023·2023-04-12

    Alprazolam 0.5 mg tablets recalled due to manufacturing contamination

    Direct Rx is recalling Alprazolam 0.5 mg tablets (Lot 11AP2219, expires 4/30/23) nationwide due to potential cross-contamination concerns at the manufacturer. No illnesses have been reported.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0509-2023·2023-04-12

    Alprazolam 2 mg tablets recalled due to potential manufacturing cross-contamination

    Direct Rx is recalling Alprazolam C-IV 2 mg tablets (NDC 72189-121-60) due to potential cross-contamination at the manufacturer. Nine bottles distributed nationwide; affected lots include 03FE2319 and 13MY2217.

    Product
    Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0508-2023·2023-04-12

    Alprazolam 1 mg tablets recalled due to manufacturing contamination concerns

    Direct Rx is recalling Alprazolam 1 mg tablets nationwide due to potential cross contamination at the manufacturer. No illnesses or injuries have been reported.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0481-2023·2023-04-05

    FDA Recalls Glimepiride Tablets Due to Manufacturing Quality Violations

    Direct Rx is voluntarily recalling Glimepiride 2 mg tablets nationwide due to manufacturing practice violations. The recall affects multiple lot numbers of 30-count and 90-count bottles distributed across the United States.

    Product
    Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0479-2023·2023-04-05

    Ropinirole 1 mg Tablets Recalled Nationwide for Manufacturing Process Deviations

    Direct Rx is recalling Ropinirole 1 mg tablets nationwide due to manufacturing process deviations. Consult a pharmacist before stopping this medication.

    Product
    Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2023·2023-04-05

    Drug Recall: Glimepiride Tablets Due to Manufacturing Deviations

    Direct Rx is recalling Glimepiride, USP, 1 mg Tablets nationwide due to cGMP deviations. The firm-initiated recall impacts both 30-count and 90-count bottles distributed across the USA.

    Product
    Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2023·2023-04-05

    Prescription Drug Ropinirole 0.25 mg Tablets Recalled for Manufacturing Deviations

    Direct Rx is recalling Ropinirole, USP, 0.25 mg tablets (NDC 72189-0364-30, Lot 21JU2210) nationwide due to Good Manufacturing Practice (cGMP) deviations. The firm voluntarily initiated this recall on March 13, 2023.

    Product
    Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0483-2023·2023-04-05

    Drug Recall: Simvastatin 5 mg tablets due to manufacturing compliance violations

    Direct Rx is recalling 51 bottles of Simvastatin 5 mg tablets nationwide due to Good Manufacturing Practice deviations. The recall is voluntary and was initiated in March 2023.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2023·2023-04-05

    Simvastatin Tablets Recalled Nationwide Over Manufacturing Practice Deviations

    Direct Rx is recalling 269 bottles of Simvastatin 40 mg nationwide due to Good Manufacturing Practice deviations. No adverse events have been reported. Consult your healthcare provider before changing your medication.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0482-2023·2023-04-05

    Glimepiride tablet recall due to manufacturing practice deviations

    Direct Rx is recalling Glimepiride 4 mg tablets nationwide due to manufacturing process deviations. The recall is voluntary and affects specific lots of 30-count and 90-count bottles.

    Product
    Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0484-2023·2023-04-05

    Drug Manufacturer Recalls Simvastatin Tablets for Manufacturing Deviations

    Direct Rx recalled Simvastatin 10 mg tablets nationwide due to manufacturing process deviations discovered during production. No illnesses or injuries have been reported.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0477-2023·2023-04-05

    Finasteride Tablets Recalled Nationwide for Manufacturing Practice Deviations

    Direct Rx is recalling 19 bottles of Finasteride 5 mg Tablets nationwide due to cGMP deviations. The firm initiated this recall voluntarily.

    Product
    Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2023·2023-04-05

    Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations

    Direct Rx is recalling Montelukast Sodium 10 mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects approximately 508 bottles distributed across the United States.

    Product
    Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0485-2023·2023-04-05

    Simvastatin 20mg Tablets Recalled for Manufacturing Practice Deviations

    Direct Rx recalled Simvastatin 20mg tablets nationwide due to manufacturing practice deviations. The voluntary recall affects bottles distributed across the United States.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0101-2023·2023-01-18

    Moxifloxacin Ophthalmic Solution Recalled Due to Manufacturing Quality Deviation

    Direct Rx recalled 11 bottles of Moxifloxacin Ophthalmic Solution (0.5%, 3 mL) due to a cGMP deviation and discontinued stability support.

    Product
    Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1535-2022·2022-09-21

    Triamcinolone Acetonide Cream Recalled Due to Manufacturing Quality Defects

    Direct Rx is recalling Triamcinolone Acetonide cream 0.1% due to manufacturing quality deviations that resulted in gritty texture and lack of effectiveness. The affected lot is 12JY2216, expiring February 29, 2024.

    Product
    TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE CREAM)
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0971-2022·2022-06-08

    Blood Pressure Medication Losartan-HCTZ Recalled for Impurity Deviation

    Direct Rx is recalling 81 bottles of Losartan Potassium and Hydrochlorothiazide 100/12.5 mg due to AZIDO impurity exceeding acceptable manufacturing standards. Affected bottles were distributed in Alabama, Georgia, Florida, and Louisiana.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0893-2022·2022-06-01

    Losartan Potassium and Hydrochlorothiazide Recall: Impurity Levels Above Acceptable Limits

    Direct Rx is recalling Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels above acceptable limits resulting from manufacturing deviations. Patients should consult their healthcare provider regarding their medication.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0895-2022·2022-06-01

    Blood pressure medication Losartan and hydrochlorothiazide recalled for elevated azido impurity

    Direct Rx recalled Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels exceeding acceptable limits. The recall affects 11 bottles distributed in Florida.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0894-2022·2022-06-01

    Blood Pressure Medication Recalled for Manufacturing Impurity

    Direct Rx is recalling batches of Losartan Potassium/Hydrochlorothiazide tablets due to CGMP deviations with elevated AZIDO impurity levels. The affected product was distributed in Florida.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state