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16,790
Drug Enforcements
Analyze FDA drug enforcement notices, including classifications, firms, and recall scope.
Most recent report
September 24, 2025
Last updated
September 30, 2025
Drug Enforcement Records
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Page 77 of 672
| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-0503-2023 | Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 | RemedyRepack Inc. | Terminated | Class II | Apr 12, 2023 |
| D-0497-2023 | Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00 | RemedyRepack Inc. | Terminated | Class II | Apr 12, 2023 |
| D-0491-2023 | Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. | RemedyRepack Inc. | Terminated | Class II | Apr 12, 2023 |
| D-0499-2023 | Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00 | RemedyRepack Inc. | Terminated | Class II | Apr 12, 2023 |
| D-0515-2023 | Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1 | Preferred Pharmaceuticals, Inc. | Ongoing | Class II | Apr 12, 2023 |
| D-0510-2023 | Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19 | Teva Pharmaceuticals USA Inc | Terminated | Class III | Apr 12, 2023 |
| D-0514-2023 | Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1 | Preferred Pharmaceuticals, Inc. | Ongoing | Class II | Apr 12, 2023 |
| D-0507-2023 | 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. | Direct Rx | Ongoing | Class II | Apr 12, 2023 |
| D-0521-2023 | Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9 | Preferred Pharmaceuticals, Inc. | Ongoing | Class II | Apr 12, 2023 |
| D-0505-2023 | Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. | Preferred Pharmaceuticals, Inc. | Terminated | Class II | Apr 12, 2023 |
| D-0506-2023 | Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. | Preferred Pharmaceuticals, Inc. | Terminated | Class II | Apr 12, 2023 |
| D-0504-2023 | Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3 | Preferred Pharmaceuticals, Inc. | Terminated | Class II | Apr 12, 2023 |
| D-0533-2023 | Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60. | Ascend Laboratories, LLC | Ongoing | Class II | Apr 5, 2023 |
| D-0475-2023 | Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11. | Endo Pharmaceuticals, Inc. | Terminated | Class II | Apr 5, 2023 |
| D-0478-2023 | 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 | Direct Rx | Terminated | Class II | Apr 5, 2023 |
| D-0480-2023 | 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 | Direct Rx | Terminated | Class II | Apr 5, 2023 |
| D-0479-2023 | 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 | Direct Rx | Terminated | Class II | Apr 5, 2023 |
| D-0476-2023 | 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 | Direct Rx | Terminated | Class II | Apr 5, 2023 |
| D-0477-2023 | Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx | Direct Rx | Terminated | Class II | Apr 5, 2023 |
| D-0485-2023 | 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 | Direct Rx | Terminated | Class II | Apr 5, 2023 |
| D-0482-2023 | 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 | Direct Rx | Terminated | Class II | Apr 5, 2023 |
| D-0484-2023 | 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 | Direct Rx | Terminated | Class II | Apr 5, 2023 |
| D-0483-2023 | 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 | Direct Rx | Terminated | Class II | Apr 5, 2023 |
| D-0481-2023 | 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 | Direct Rx | Terminated | Class II | Apr 5, 2023 |
| D-0486-2023 | 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 | Direct Rx | Terminated | Class II | Apr 5, 2023 |