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16,790
Drug Enforcements
Analyze FDA drug enforcement notices, including classifications, firms, and recall scope.
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September 24, 2025
Last updated
September 30, 2025
Drug Enforcement Records
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| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-136-2014 | HCG 340 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | Main Street Family Pharmacy, LLC | Terminated | Class II | Dec 11, 2013 |
| D-261-2014 | Pre-Menopausal Pack 3rd Month, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | Main Street Family Pharmacy, LLC | Terminated | Class II | Dec 11, 2013 |
| D-035-2014 | AMIC-12 w/out lido10ml , Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | Main Street Family Pharmacy, LLC | Terminated | Class II | Dec 11, 2013 |
| D-127-2014 | HCG 270 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | Main Street Family Pharmacy, LLC | Terminated | Class II | Dec 11, 2013 |
| D-281-2014 | Test Cypionate 20mg/ml 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | Main Street Family Pharmacy, LLC | Terminated | Class II | Dec 11, 2013 |
| D-092-2014 | Estradiol Pellets 15mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | Main Street Family Pharmacy, LLC | Terminated | Class II | Dec 11, 2013 |
| D-214-2014 | Methylprednisolone 40mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | Main Street Family Pharmacy, LLC | Terminated | Class II | Dec 11, 2013 |
| D-139-2014 | HCG 370iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | Main Street Family Pharmacy, LLC | Terminated | Class II | Dec 11, 2013 |
| D-104-2014 | HCG 10000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | Main Street Family Pharmacy, LLC | Terminated | Class II | Dec 11, 2013 |
| D-202-2014 | Medroxyprogesterone (PF) 150mg/10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | Main Street Family Pharmacy, LLC | Terminated | Class II | Dec 11, 2013 |
| D-323-2014 | Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01 | American Health Packaging | Terminated | Class II | Dec 11, 2013 |
| D-016-2014 | PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India | Fresenius Kabi USA, LLC | Terminated | Class III | Dec 4, 2013 |
| D-017-2014 | Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.,Weston, Florida 33326. | Apotex Inc. | Terminated | Class II | Dec 4, 2013 |
| D-020-2014 | Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx Only, Sample - not for sale, CORIA Laboratories, a division of Valeant Pharmaceuticals LLC, Bridgewater, NJ 08807 --- NDC 13548-132-03 | Valeant Pharmaceuticals North Am | Terminated | Class III | Dec 4, 2013 |
| D-022-2014 | Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Consumer Health, Inc, Lincoln, NE / There are 7 different labels under which this product is packaged but the active ingredient is the same. 1) DOLLAR GENERAL LABEL: DG Health Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 60 tablet blister packs (UPC code: 300436122) and 30 tablet blister packs (UPC code: 300676122304). Distributed by Dolgencorp, LLC, Goodlettsville, TN. 2) FAMILY DOLLAR LABEL: Family Wellness Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 032251004292). Distributed by Family Dollar Services, Inc, Matthews, NC. 3) FAMILY DOLLAR LABEL Family Dollar Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 400910131502). Manufactured by Novartis Consumer Health, Inc, Lincoln, NE and Distributed by Family Dollar Services, Inc, Charlotte, NC. 4) TARGET LABEL: Allergy Relief Medication, loratadine, 10 mg/antihistamine, packaged in 10 tablet (UPC 300670675103), 15 tablet (UPC 300670668150), 30 tablet (UPC 300670675301), 40 tablet (UPC 300670675400), and 60 tablet (UPC 300670675004) blister packs. It is also packaged in 120 tablet (UPC 300670675127) and 180 tablet (UPC 300676255736) bottles. Dist. by Target Corporation, Minneapolis, MN. 5) PRIVATE LABEL: Loratadine 10mg, Antihistamine, packaged in 10 tablet (UPC 300670674106) and 30 tablet (UPC 300670674304) blister packs. Manufactured and Distributed by: Novartis Consumer Health, Inc., Lincoln, NE. 6) WALMART LABEL, Equate, Allergy Relief, Loratadine Tablets, 10 mg, Antihistamine, packaged in 10 tablet (UPC 681131739276) and 30 tablet (UPC 681131739283) blister packs. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. 7) CVS LABEL: CVS Pharmacy, Allergy Relief, Loratadine 10mg/Antihistamine, packaged in 5 tablet (UPC 050428068595), 10 tablet (UPC 050428046784), 20 tablet (UPC 050428065747) (UPC 050428579350), and 30 tablet (UPC 050428046791) blister packs. Also packaged in 120 tablet (UPC 050428065822) and 365 tablet (UPC 050428160282) plastic bottles. Manufactured by: Novartis Consumer Health, Inc., Lincoln, NE, for: CVS Pharmacy, Inc., Woonsocket, RI. | Novartis Consumer Health | Terminated | Class III | Dec 4, 2013 |
| D-021-2014 | J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 hours, 4-count tablets per blister pack, Order at: www.jackrabbitfourpack.com, Jack Rabbit Inc., 4355 Dow Road, Melbourne, FL 32934 | Jack Rabbit, Inc | Terminated | Class I | Dec 4, 2013 |
| D-013-2014 | Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03 | Hospira Inc. | Terminated | Class II | Nov 27, 2013 |
| D-004-2014 | Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, Ohio 43017, NDC 37205-577-16, UPC 0 96295 12095 0; b) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0161-16, UPC 3 11917 13221 1; c) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-161-16, UPC 0 41260 35831 9; d) H-E-B Pain & Fever acetaminophen suspension Infants', Made With Pride & Care For H-E-B, San Antonio, TX 78204, NDC 37808-161-16, UPC 0 41220 88066 9; e) Babies R Us Infants' Pain & Fever acetaminophen suspension, Distributed by Toys R Us, Inc., Wayne, NJ 07470, NDC 51334-161-16, UPC 7 17851 20094 6; f) healthy accents infants' pain & fever acetaminophen suspension liquid, Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074, NDC 55316-161-16, UPC 7 25439 95814 1; g) Health Mart Pharmacy infants' pain & fever acetaminophen suspension liquid, Distributed by McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0002-1, UPC 0 52569 13248 7 | L. Perrigo Co. | Terminated | Class II | Nov 27, 2013 |
| D-001-2014 | Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas City, MO 64131; Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30, UPC 3 68546 31730 4. | Teva Pharmaceuticals USA | Terminated | Class II | Nov 27, 2013 |
| D-002-2014 | Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59 | Boehringer Ingelheim Roxane Inc | Terminated | Class II | Nov 27, 2013 |
| D-012-2014 | Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01 | Hospira Inc. | Terminated | Class II | Nov 27, 2013 |
| D-005-2014 | Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA 17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-766-16, UPC 0 41260 35830 2 | L. Perrigo Co. | Terminated | Class II | Nov 27, 2013 |
| D-014-2014 | Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31 | Pfizer Us Pharmaceutical Group | Terminated | Class II | Nov 27, 2013 |
| D-003-2014 | Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe in a carton and sold under the following: a) equaling infants' pain & fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by SUPERVALU Inc., Eden Prairie, MN 55344, NDC 41163-590-16, UPC 0 41163 48657 7; b) Up & Up dye free infants' pain and fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-590-16, UPC 3 70030 62529 1; c) equate Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-590-16, UPC 6 81131 00185 4; d) Meijer Infants' Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, NDC 41250-590-16, UPC 7 13733 31376 6; e) Walgreens infants' Dye-Free Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0590-16, UPC 3 11917 13222 8; f) Kroger Infants' Pain & Fever suspension liquid, 4 FL OZ (118 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-26, UPC 0 41260 36738 0; g) Kroger Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-16, UPC 0 41260 35829 6; h) Publix Infants' painrelief acetaminophen suspension liquid, 2 FL OZ (59 mL), Distributed By Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 55062-590-16, UPC 0 41415 39573 2; i) CareOne Infants' Dye-Free Pain Relief acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed By Foodhold U.S.A., LLC, Landover, MD 20785, NDC 41520-590-16, UPC 3 41520 31006 5; j) Harmon FaceValues Infants' Pain & Fever acetaminophen suspension Liquid, 2 FL OZ (59 mL), Distributed by Harmon Stores, Inc., 650 Liberty Ave., Union, NJ 07083 USA, UPC 3 70030 51018 4 | L. Perrigo Co. | Terminated | Class II | Nov 27, 2013 |
| D-006-2014 | Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) equate Infants' Pain & Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc., Bentonville, AZ 72716, NDC 49035-946-16, UPC 0 78742 09060 3; b) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-576-16, UPC 0 96295 12093 6; c) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-946-16, UPC 0 36800 34645 1; d) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0946-16, UPC 3 11917 13225 9; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-946-16, UPC 0 41260 35832 6 | L. Perrigo Co. | Terminated | Class II | Nov 27, 2013 |