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 14511475 of 5,012 active FDA enforcement records

  • Class IIICompleted
    Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box). · Jul 17, 2024 · United States
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  • Class IIOngoing
    Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2 · Jul 17, 2024 · United States
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  • Class IIIOngoing
    Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5. · Jul 17, 2024 · United States
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  • Class IIIOngoing
    Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, · Jul 17, 2024 · United States
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  • Class IITerminated
    Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 01450 90008 6, NDC # 53228-002-01, Equibal Labs, Inc · Jul 17, 2024 · United States
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  • Class IIOngoing
    buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01. · Jul 17, 2024 · United States
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  • Class IIOngoing
    suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 - IVORY b) NDC: 69949-156-01, UPC: 854245006224 - NUDE c) NDC: 69949-152-01, UPC: 854245006187 - BUFF d) NDC: 69949-153-01, UPC: 854245006194 - SAND e) NDC: 69949-155-01, UPC: 854245006217 - BRONZE f) NDC: 69949-157-01, UPC: 854245006446 - MOCHA · Jul 17, 2024 · United States
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  • 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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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.