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-0458-2024 | HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A | Pyramids Wholesale Inc. | Ongoing | Class I | May 1, 2024 |
D-0460-2024 | Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5 | Aruba Aloe Balm N.V. | Ongoing | Class I | May 1, 2024 |
D-0449-2024 | Weiner Boner Honey, 12g packet, 100% Organic Formula. | Pyramids Wholesale Inc. | Ongoing | Class I | May 1, 2024 |
D-0470-2024 | ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card. | FA Online Inc | Terminated | Class I | May 1, 2024 |
D-0474-2024 | minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30. | EPI Health, LLC | Terminated | Class II | May 1, 2024 |
D-0444-2024 | Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12. | AvKARE | Terminated | Class I | Apr 24, 2024 |
D-0445-2024 | Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01 | Eli Lilly & Company | Completed | Class II | Apr 24, 2024 |
D-0441-2024 | NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03 | Esperion | Completed | Class III | Apr 24, 2024 |
D-0442-2024 | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 | Amneal Pharmaceuticals of New York, LLC | Terminated | Class I | Apr 24, 2024 |
D-0446-2024 | S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01. | Specialty Process Labs LLC | Ongoing | Class II | Apr 24, 2024 |
D-0447-2024 | S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03 | Specialty Process Labs LLC | Ongoing | Class II | Apr 24, 2024 |
D-0443-2024 | Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10 | Novitium Pharma LLC | Terminated | Class III | Apr 24, 2024 |
D-0439-2024 | Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15 | Teva Pharmaceuticals USA, Inc | Ongoing | Class II | Apr 17, 2024 |
D-0437-2024 | Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06 | Lupin Pharmaceuticals Inc. | Terminated | Class II | Apr 17, 2024 |
D-0440-2024 | Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10 | Eugia US LLC | Ongoing | Class I | Apr 17, 2024 |
D-0438-2024 | Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41 | NATCO Pharma Limited | Ongoing | Class II | Apr 17, 2024 |
D-0433-2024 | Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01. | X-Gen Pharmaceuticals Inc. | Completed | Class III | Apr 10, 2024 |
D-0431-2024 | Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00 | B. Braun Medical Inc | Terminated | Class II | Apr 10, 2024 |
D-0435-2024 | Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1 | SSM Health Care St. Louis DBA SSM St. Clare Health Center | Ongoing | Class II | Apr 10, 2024 |
D-0432-2024 | fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1 | IntegraDose Compounding Services LLC | Ongoing | Class II | Apr 10, 2024 |
D-0430-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01 | Glenmark Pharmaceuticals Inc., USA | Ongoing | Class II | Apr 10, 2024 |
D-0436-2024 | FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1 | SSM Health Care St. Louis DBA SSM St. Clare Health Center | Ongoing | Class II | Apr 10, 2024 |
D-0427-2024 | VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01 | Apothecus Pharmaceutical Corp. | Terminated | Class II | Apr 3, 2024 |
D-0426-2024 | Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10 | Amneal Pharmaceuticals of New York, LLC | Terminated | Class II | Apr 3, 2024 |
D-0429-2024 | Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01 | PAR Sterile Products LLC | Ongoing | Class I | Apr 3, 2024 |