Total records
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
Sorted by most recent report date.
Back to datasets
Page 79 of 672
| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-0443-2023 | Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15 | Denver Solutions, LLC DBA Leiters Health | Terminated | Class II | Mar 15, 2023 |
| D-0447-2023 | Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854 | Ecometics, Inc. | Terminated | Class II | Mar 15, 2023 |
| D-0444-2023 | Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82 | Denver Solutions, LLC DBA Leiters Health | Terminated | Class II | Mar 15, 2023 |
| D-0448-2023 | Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 | Ecometics, Inc. | Terminated | Class II | Mar 15, 2023 |
| D-0449-2023 | Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars | Ecometics, Inc. | Terminated | Class II | Mar 15, 2023 |
| D-0451-2023 | Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155 | Ecometics, Inc. | Terminated | Class II | Mar 15, 2023 |
| D-0452-2023 | Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 | Ecometics, Inc. | Terminated | Class II | Mar 15, 2023 |
| D-0446-2023 | Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: The Larkspur Group Inc. South Norwalk, CT 06854 | Ecometics, Inc. | Terminated | Class II | Mar 15, 2023 |
| D-0438-2023 | NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2 | Nutraceutical Corporation | Ongoing | Class II | Mar 15, 2023 |
| D-0437-2023 | NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9 | Nutraceutical Corporation | Ongoing | Class II | Mar 15, 2023 |
| D-0456-2023 | Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ. | Pharmedica USA, LLC | Ongoing | Class I | Mar 15, 2023 |
| D-0455-2023 | Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04. | Nanomaterials Discovery Corporation | Ongoing | Class I | Mar 15, 2023 |
| D-0441-2023 | Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60 | Teva Pharmaceuticals USA Inc | Terminated | Class II | Mar 15, 2023 |
| D-0440-2023 | NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0 | Nutraceutical Corporation | Ongoing | Class II | Mar 15, 2023 |
| D-0457-2023 | Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5 | Pharmedica USA, LLC | Ongoing | Class II | Mar 15, 2023 |
| D-0439-2023 | NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA | Nutraceutical Corporation | Ongoing | Class II | Mar 15, 2023 |
| D-0450-2023 | Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 | Ecometics, Inc. | Terminated | Class II | Mar 15, 2023 |
| D-0364-2023 | Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01 | Nephron Sc Inc | Terminated | Class II | Mar 8, 2023 |
| D-0432-2023 | Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4 | The Harvard Drug Group | Terminated | Class II | Mar 8, 2023 |
| D-0391-2023 | Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 2 | ACCORD HEALTHCARE, INC. | Terminated | Class II | Mar 8, 2023 |
| D-0379-2023 | BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-289-12 UPC 3 16729 28912 2 | ACCORD HEALTHCARE, INC. | Terminated | Class II | Mar 8, 2023 |
| D-0383-2023 | Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-490-12 UPC 3 16729 49012 2 | ACCORD HEALTHCARE, INC. | Terminated | Class II | Mar 8, 2023 |
| D-0397-2023 | Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 2 ML vial NDC 16729-472-30 UPC 3 16729 47230 2; carton NDC 16729-472-08 UPC 3 16729 47208 1 | ACCORD HEALTHCARE, INC. | Terminated | Class II | Mar 8, 2023 |
| D-0426-2023 | rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, UPC 3 16729 23301 9 | ACCORD HEALTHCARE, INC. | Terminated | Class II | Mar 8, 2023 |
| D-0417-2023 | Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA | ACCORD HEALTHCARE, INC. | Terminated | Class II | Mar 8, 2023 |