Home / Brand archive

Direct Rx recall records

8 reported ongoing

30 records in this archive. Latest source date Jun 22, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

Jun 22, 2026FDA drug enforcement

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.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIReported ongoing

Distribution: U.S. Nationwide

Official source

Mar 7, 2025FDA drug enforcement

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

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIReported ongoing

Distribution: Nationwide

Official source

Mar 7, 2025FDA drug enforcement

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...

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIReported ongoing

Distribution: Nationwide

Official source

Jan 31, 2025FDA drug enforcement

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

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 IIReported ongoing

Distribution: Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID

Official source

Aug 9, 2024FDA drug enforcement

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 Laboratorie...

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.

Class IIReported ongoing

Distribution: Nationwide in the US

Official source

Mar 22, 2023FDA drug enforcement

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.

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Mar 22, 2023FDA drug enforcement

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,...

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Mar 22, 2023FDA drug enforcement

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

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source

Mar 13, 2023FDA drug enforcement

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: ...

cGMP deviations

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Mar 13, 2023FDA drug enforcement

Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx

cGMP deviations

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Mar 13, 2023FDA drug enforcement

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

cGMP deviations

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Mar 13, 2023FDA drug enforcement

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

cGMP deviations

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Mar 13, 2023FDA drug enforcement

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, Dawso...

cGMP deviations

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Mar 13, 2023FDA drug enforcement

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, Dawso...

cGMP deviations

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Mar 13, 2023FDA drug enforcement

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, Dawso...

cGMP deviations

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Mar 13, 2023FDA drug enforcement

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

cGMP deviations

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Mar 13, 2023FDA drug enforcement

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, Dawso...

cGMP deviations

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Mar 13, 2023FDA drug enforcement

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, Daws...

cGMP deviations

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Mar 13, 2023FDA drug enforcement

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

cGMP deviations

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Nov 2, 2022FDA drug enforcement

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

cGMP deviation: discontinue of stability support for product.

Class IIReported terminated

Distribution: FL

Official source

Reasons in these listed records

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
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
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.

These examples come from this result page and are not a ranking of every recall reason.

Checking Direct Rx

Is there a recall on direct rx right now?

This archive contains 30 records, including 8 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

Keep checking