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 39513975 of 4,707 active FDA enforcement records · Country: united states

  • Class IITerminated
    Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx · Feb 16, 2022 · United States
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  • Class IITerminated
    4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00 · Feb 16, 2022 · United States
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  • Class IITerminated
    3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00 · Feb 16, 2022 · United States
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  • Class IIITerminated
    Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42 · Feb 9, 2022 · United States
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  • Class IIITerminated
    Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28 · Feb 9, 2022 · United States
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  • Class IITerminated
    Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02 · Feb 9, 2022 · United States
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  • Class IITerminated
    Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007 · Feb 9, 2022 · United States
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  • Class IITerminated
    Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007 · Feb 9, 2022 · United States
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  • Class IITerminated
    REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487 · Feb 9, 2022 · United States
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  • Class IITerminated
    REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487 · Feb 9, 2022 · United States
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  • Class IITerminated
    ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 · Feb 9, 2022 · United States
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  • Class IITerminated
    MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 · Feb 9, 2022 · United States
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  • Class IITerminated
    SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 · Feb 9, 2022 · United States
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  • Class IITerminated
    AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 · Feb 9, 2022 · United States
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  • Class IITerminated
    CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 · Feb 9, 2022 · United States
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  • Class IITerminated
    CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 · Feb 9, 2022 · United States
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  • Class IITerminated
    FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 · Feb 9, 2022 · United States
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  • Class IITerminated
    Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 · Feb 9, 2022 · United States
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  • Class IITerminated
    Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124 · Feb 9, 2022 · United States
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  • Class IITerminated
    MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6 · Feb 9, 2022 · United States
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  • Class IITerminated
    CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895 · Feb 9, 2022 · United States
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  • Class IITerminated
    PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060. · Feb 9, 2022 · United States
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  • Class IITerminated
    PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060. · Feb 9, 2022 · United States
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  • Class IITerminated
    PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060. · Feb 9, 2022 · United States
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  • Class IITerminated
    PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060. · Feb 9, 2022 · 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.