Total records
16,790
Analyze FDA drug enforcement notices, including classifications, firms, and recall scope.
Total records
16,790
Most recent report
September 24, 2025
Last updated
September 30, 2025
Sorted by most recent report date.
Recall # | Product | Firm | Status | Classification | Report date |
---|---|---|---|---|---|
D-0665-2024 | Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042 | AbbVie Inc. | Ongoing | Class II | Oct 2, 2024 |
D-0666-2024 | Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216 1566, http://www.dalayurevda.com, Made in India, UPC: 042535355019 | Guru Inc. | Ongoing | Class II | Oct 2, 2024 |
D-0664-2024 | Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043, | AbbVie Inc. | Ongoing | Class II | Oct 2, 2024 |
D-0663-2024 | Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1. | Empower Pharmacy | Terminated | Class II | Oct 2, 2024 |
D-0659-2024 | AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01 | Rubicon Research Private Limited | Ongoing | Class III | Sep 25, 2024 |
D-0658-2024 | Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1 | Elevate Oral Care | Terminated | Class III | Sep 18, 2024 |
D-0657-2024 | BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4 | PREQUEL SKIN | Ongoing | Class II | Sep 18, 2024 |
D-0649-2024 | Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04 | Baxter Healthcare Corporation | Ongoing | Class I | Sep 11, 2024 |
D-0653-2024 | SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04 | ProRx LLC | Ongoing | Class II | Sep 11, 2024 |
D-0650-2024 | Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01 | ProRx LLC | Ongoing | Class II | Sep 11, 2024 |
D-0654-2024 | Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02 | ProRx LLC | Ongoing | Class II | Sep 11, 2024 |
D-0651-2024 | Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01 | ProRx LLC | Ongoing | Class II | Sep 11, 2024 |
D-0652-2024 | SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01 | ProRx LLC | Ongoing | Class II | Sep 11, 2024 |
D-0655-2024 | TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01 | ProRx LLC | Ongoing | Class II | Sep 11, 2024 |
D-0656-2024 | TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02 | ProRx LLC | Ongoing | Class II | Sep 11, 2024 |
D-0648-2024 | Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01 | Lupin Pharmaceuticals Inc. | Terminated | Class II | Sep 4, 2024 |
D-0645-2024 | IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle. | Dr. Reddy's Laboratories, Inc. | Ongoing | Class II | Sep 4, 2024 |
D-0644-2024 | IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle. | Dr. Reddy's Laboratories, Inc. | Ongoing | Class II | Sep 4, 2024 |
D-0643-2024 | Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. | Glenmark Pharmaceuticals Inc., USA | Ongoing | Class II | Sep 4, 2024 |
D-0647-2024 | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03. | Preferred Pharmaceuticals, Inc. | Ongoing | Class II | Sep 4, 2024 |
D-0646-2024 | IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle. | Dr. Reddy's Laboratories, Inc. | Ongoing | Class II | Sep 4, 2024 |
D-0635-2024 | Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01 | Hikma Pharmaceuticals USA Inc. | Ongoing | Class I | Aug 28, 2024 |
D-0638-2024 | 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09. | B. Braun Medical Inc | Ongoing | Class I | Aug 28, 2024 |
D-0642-2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey | FDC Limited | Ongoing | Class II | Aug 28, 2024 |
D-0636-2024 | Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226. | Fagron Compounding Services | Ongoing | Class II | Aug 28, 2024 |