Direct Rx: 37 FDA recall reports
Every drug recall the FDA has published for Direct Rx. The fault, and how the agency graded it.
37Reports
0Class I
8Ongoing
2026-07-01Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged
D-0617-2026 · Class II · reported 2026-07-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- 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.
- Where it went
- U.S. Nationwide
- How much
- 263 Bottles
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breck
D-0567-2025 · Class II · reported 2025-08-13 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- 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
- Where it went
- Nationwide
- How much
- 16 bottles
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle,
D-0568-2025 · Class II · reported 2025-08-13 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- 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,
- Where it went
- Nationwide
- How much
- 875 bottles
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRE
D-0364-2025 · Class II · reported 2025-04-23 · Ongoing
- Why it was recalled
- 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
- Product
- CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
- Where it went
- Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID
- How much
- 477 bottles.
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed b
D-0041-2025 · Class II · reported 2024-11-13 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 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 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).
- Where it went
- Nationwide in the US
- How much
- 1410 bottles
Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-2
D-0508-2023 · Class II · reported 2023-04-12 · Ongoing
- Why it was recalled
- CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
- 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.
- Where it went
- Nationwide in the USA
- How much
- 349 bottles
Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 305
D-0509-2023 · Class II · reported 2023-04-12 · Ongoing
- Why it was recalled
- CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
- 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.
- Where it went
- Nationwide in the USA
- How much
- 9 bottles
Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 3
D-0507-2023 · Class II · reported 2023-04-12 · Ongoing
- Why it was recalled
- CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
- 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.
- Where it went
- Nationwide in the USA
- How much
- 20 bottles
Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bott
D-0480-2023 · Class II · reported 2023-04-05 · Terminated
- Why it was recalled
- cGMP deviations
- 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
- Where it went
- Nationwide in the USA
- How much
- 30 count: 4 bottles; 90 count: 172 bottles
Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distrib
D-0483-2023 · Class II · reported 2023-04-05 · Terminated
- Why it was recalled
- cGMP deviations
- 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
- Where it went
- Nationwide in the USA
- How much
- 51 bottles
Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed B
D-0486-2023 · Class II · reported 2023-04-05 · Terminated
- Why it was recalled
- cGMP deviations
- 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
- Where it went
- Nationwide in the USA
- How much
- 269 bottles
Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Dist
D-0478-2023 · Class II · reported 2023-04-05 · Terminated
- Why it was recalled
- cGMP deviations
- 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
- Where it went
- Nationwide in the USA
- How much
- 9 bottles
Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bott
D-0482-2023 · Class II · reported 2023-04-05 · Terminated
- Why it was recalled
- cGMP deviations
- 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
- Where it went
- Nationwide in the USA
- How much
- 30 count: 7 bottles; 90 count: 395 bottles
Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bott
D-0481-2023 · Class II · reported 2023-04-05 · Terminated
- Why it was recalled
- cGMP deviations
- 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
- Where it went
- Nationwide in the USA
- How much
- 30 count: 12 bottles; 90 count: 253 bottles
Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distrib
D-0479-2023 · Class II · reported 2023-04-05 · Terminated
- Why it was recalled
- cGMP deviations
- 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
- Where it went
- Nationwide in the USA
- How much
- 4 bottles
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bott
D-0484-2023 · Class II · reported 2023-04-05 · Terminated
- Why it was recalled
- cGMP deviations
- 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
- Where it went
- Nationwide in the USA
- How much
- 30 count: 6 bottles; 90 count: 106 bottles
Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distri
D-0477-2023 · Class II · reported 2023-04-05 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
- Where it went
- Nationwide in the USA
- How much
- 19 bottles
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b
D-0476-2023 · Class II · reported 2023-04-05 · Terminated
- Why it was recalled
- cGMP deviations
- 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
- Where it went
- Nationwide in the USA
- How much
- 90 count: 495 bottles; 30 count: 13 bottles
Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bott
D-0485-2023 · Class II · reported 2023-04-05 · Terminated
- Why it was recalled
- cGMP deviations
- 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
- Where it went
- Nationwide in the USA
- How much
- 30 count: 5 bottles; 90 count: 53 bottles
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwid
D-0101-2023 · Class II · reported 2023-01-18 · Terminated
- Why it was recalled
- cGMP deviation: discontinue of stability support for product.
- 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
- Where it went
- FL
- How much
- 11 bottles
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville,
D-1535-2022 · Class II · reported 2022-09-21 · Completed
- Why it was recalled
- CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
- Product
- Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
- Where it went
- Physicians and Medical Facilities in GA and ID
- How much
- 20 tubes
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pha
D-0971-2022 · Class II · reported 2022-06-08 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
- Where it went
- AL, GA, FL, LA
- How much
- 81 bottles
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville
D-0888-2022 · Class II · reported 2022-06-01 · Terminated
- Why it was recalled
- CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
- Product
- Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
- Where it went
- Nationwide to the U.S. market
- How much
- 16 bottles
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA
D-0893-2022 · Class II · reported 2022-06-01 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- Product
- Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
- Where it went
- FL
- How much
- 11 bottles
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 3
D-0894-2022 · Class II · reported 2022-06-01 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- Product
- Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
- Where it went
- FL
- How much
- 6 bottles
Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30
D-0895-2022 · Class II · reported 2022-06-01 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- Product
- Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
- Where it went
- FL
- How much
- 11 bottles
Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville,
D-0714-2022 · Class II · reported 2022-03-30 · Terminated
- Why it was recalled
- Defective Container: Leaking containers.
- Product
- Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05
- Where it went
- Nationwide within the United States
- How much
- 312 bottles
Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged
D-0650-2022 · Class II · reported 2022-03-16 · Terminated
- Why it was recalled
- CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
- Product
- Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60
- Where it went
- FL, GA, LA
- How much
- 16 bottles
Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Package
D-0651-2022 · Class II · reported 2022-03-16 · Terminated
- Why it was recalled
- CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
- Product
- Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60
- Where it went
- FL, GA, LA
- How much
- 8 bottles
Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
D-0637-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- Failed impurities/degradation specifications
- Product
- Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
- Where it went
- Florida
- How much
- 44 bottles
Showing the 30 most recent of 37. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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