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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 11 of 672
| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-0391-2025 | Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03. | Preferred Pharmaceuticals, Inc. | Ongoing | Class II | May 7, 2025 |
| D-0392-2025 | Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial). | Nubratori, Inc | Ongoing | Class II | May 7, 2025 |
| D-0400-2025 | Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01 | Mckesson Medical-Surgical Inc. Corporate Office | Ongoing | Class II | May 7, 2025 |
| D-0397-2025 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15 | ACCORD HEALTHCARE, INC. | Ongoing | Class II | May 7, 2025 |
| D-0399-2025 | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01] | American Regent, Inc. | Ongoing | Class II | May 7, 2025 |
| D-0401-2025 | Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product of Canada, NDC 54643-5649-1 | Mckesson Medical-Surgical Inc. Corporate Office | Ongoing | Class II | May 7, 2025 |
| D-0389-2025 | Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01 | Eugia US LLC | Ongoing | Class II | May 7, 2025 |
| D-0398-2025 | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01. | American Regent, Inc. | Ongoing | Class II | May 7, 2025 |
| D-0395-2025 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17. | ACCORD HEALTHCARE, INC. | Ongoing | Class II | May 7, 2025 |
| D-0390-2025 | Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01 | Eugia US LLC | Ongoing | Class II | May 7, 2025 |
| D-0396-2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17 | ACCORD HEALTHCARE, INC. | Ongoing | Class II | May 7, 2025 |
| D-0379-2025 | DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15 | Pharmadel, LLC | Ongoing | Class II | Apr 30, 2025 |
| D-0380-2025 | DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15 | Pharmadel, LLC | Ongoing | Class II | Apr 30, 2025 |
| D-0373-2025 | Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11 | Denver Solutions, LLC DBA Leiters Health | Ongoing | Class II | Apr 30, 2025 |
| D-0378-2025 | Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00 | RemedyRepack Inc. | Ongoing | Class II | Apr 30, 2025 |
| D-0372-2025 | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11, | Denver Solutions, LLC DBA Leiters Health | Ongoing | Class II | Apr 30, 2025 |
| D-0367-2025 | Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41. | Amerisource Health Services LLC | Ongoing | Class II | Apr 30, 2025 |
| D-0375-2025 | Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318 | Apipharma | Ongoing | Class II | Apr 30, 2025 |
| D-0383-2025 | Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99 | Pharmadel, LLC | Ongoing | Class II | Apr 30, 2025 |
| D-0376-2025 | Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363 | Apipharma | Ongoing | Class II | Apr 30, 2025 |
| D-0382-2025 | Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02 | Pharmadel, LLC | Ongoing | Class II | Apr 30, 2025 |
| D-0370-2025 | Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11 | Denver Solutions, LLC DBA Leiters Health | Ongoing | Class II | Apr 30, 2025 |
| D-0388-2025 | Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922 | Breckenridge Pharmaceutical, Inc | Ongoing | Class II | Apr 30, 2025 |
| D-0371-2025 | dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11. | Denver Solutions, LLC DBA Leiters Health | Ongoing | Class II | Apr 30, 2025 |
| D-0368-2025 | Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41. | Amerisource Health Services LLC | Ongoing | Class II | Apr 30, 2025 |