FDA Enforcement Records

Explore FDA enforcement records

Browse published US FDA drug-enforcement recall records. Filter by country, classification, status, or date.

Clear

Showing 15011525 of 5,012 active FDA enforcement records

  • Class IICompleted
    Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10, · Jun 19, 2024 · United States
    View firm →
  • Class IIITerminated
    Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37 · Jun 12, 2024 · United States
    View firm →
  • Class IIIOngoing
    Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8 · Jun 12, 2024 · United States
    View firm →
  • Class IIIOngoing
    Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8 · Jun 12, 2024 · United States
    View firm →
  • Class IIIOngoing
    Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10 · Jun 12, 2024 · United States
    View firm →
  • Class IIIOngoing
    Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9207-1. · Jun 12, 2024 · United States
    View firm →
  • Class IIIOngoing
    Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9206-1. · Jun 12, 2024 · United States
    View firm →
  • Class IIIOngoing
    Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-8858-1. · Jun 12, 2024 · United States
    View firm →
  • Class IIIOngoing
    Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1. · Jun 12, 2024 · United States
    View firm →
  • Class IIIOngoing
    Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1. · Jun 12, 2024 · United States
    View firm →
  • Class IIOngoing
    Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06 · Jun 12, 2024 · United States
    View firm →
  • Class IIOngoing
    Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06 · Jun 12, 2024 · United States
    View firm →
  • Class IIOngoing
    Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99 · Jun 12, 2024 · United States
    View firm →
  • Class IIOngoing
    Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99 · Jun 12, 2024 · United States
    View firm →
  • Class IITerminated
    EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54 · Jun 5, 2024 · United States
    View firm →
  • Class IIOngoing
    ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421 7 · Jun 5, 2024 · United States
    View firm →
  • Class IIOngoing
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294 00006 2 · Jun 5, 2024 · United States
    View firm →
  • Class IIOngoing
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00010 9 · Jun 5, 2024 · United States
    View firm →
  • Class IIOngoing
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002 4 · Jun 5, 2024 · United States
    View firm →
  • Class IIOngoing
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Tiger LLC Made in USA, UPC 1 82294 00004 8 · Jun 5, 2024 · United States
    View firm →
  • Class IIOngoing
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00019 2 · Jun 5, 2024 · United States
    View firm →
  • Class IIOngoing
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00011 6 · Jun 5, 2024 · United States
    View firm →
  • Class IIOngoing
    ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands. · Jun 5, 2024 · United States
    View firm →
  • Class IIOngoing
    Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX 75360 USA. UPC 8 50016 52112 5 · Jun 5, 2024 · United States
    View firm →
  • Class IIOngoing
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in USA, UPC 1 82294 00005 5 · Jun 5, 2024 · United States
    View firm →

Only the latest five years of published US FDA drug-enforcement recall records are indexed. The displayed entity is an FDA-recorded recalling firm; country, city, and state are source attributes, not proof of manufacturer, parent company, ownership, legal entity, safety, compliance, or approval.