FDA Enforcement Records

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

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Showing 1601–1625 of 5,012 active FDA enforcement records

  • Class IOngoing
    suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187 · Jul 17, 2024 · United States
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  • Class IIOngoing
    Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01 · Jul 17, 2024 · United States
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  • Class IOngoing
    To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026 · Jul 10, 2024 · United States
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  • Class IOngoing
    RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026 · Jul 10, 2024 · United States
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  • Class IITerminated
    Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614 · Jul 10, 2024 · United States
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  • Class IITerminated
    Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01. · Jul 10, 2024 · United States
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  • Class IIOngoing
    Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40. · Jul 10, 2024 · United States
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  • Class IIIOngoing
    Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30 · Jul 10, 2024 · United States
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  • Class IIITerminated
    Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308 · Jul 10, 2024 · United States
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  • Class IITerminated
    Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10 · Jul 10, 2024 · United States
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  • Class IIOngoing
    Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798 0, NDC 70722-319-04; Little Moon Essentials LLC Dania Beach, Fl 33004 · Jul 10, 2024 · United States
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  • Class IIOngoing
    Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004 · Jul 10, 2024 · United States
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  • Class IIOngoing
    Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b) 3 OZ (85.05G) metal tin, UPC Code 6 73673 88208 4, NDC 70722-208-03; Little Moon Essentials LLC Dania Beach, Fl 33004 · Jul 10, 2024 · United States
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  • Class IIOngoing
    Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220 6, NDC 70722-229-02; c) 4OZ (113G) glass jar, UPC Code 6 73673 88218 3, NDC 70722-229-04; Little Moon Essentials LLC Dania Beach, Fl 33004 · Jul 10, 2024 · United States
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  • Class IIOngoing
    Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004 · Jul 10, 2024 · United States
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  • Class IIOngoing
    Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004 · Jul 10, 2024 · United States
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  • Class IIOngoing
    Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004 · Jul 10, 2024 · United States
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  • Class IIOngoing
    Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722-246-04; Little Moon Essentials LLC Dania Beach, Fl 33004 · Jul 10, 2024 · United States
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  • Class IICompleted
    Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00. · Jul 10, 2024 · United States
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  • Class IIIOngoing
    SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9. · Jul 3, 2024 · United States
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  • Class IITerminated
    Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012. · Jul 3, 2024 · United States
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  • Class IIOngoing
    Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01 · Jul 3, 2024 · United States
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  • Class IIOngoing
    Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606 · Jul 3, 2024 · United States
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  • Class IIOngoing
    Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24 · Jul 3, 2024 · United States
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  • Class IIOngoing
    Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03 · Jul 3, 2024 · United States
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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.