Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on July 25, 2025 and include a total of 16975 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1151-2018 | 08-02-2018 | Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 2085 vials | Class II | Terminated |
| D-1153-2018 | 08-02-2018 | Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 6 vials | Class II | Terminated |
| D-1147-2018 | 08-02-2018 | Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 5718 vials | Class II | Terminated |
| D-1152-2018 | 08-02-2018 | Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 3351 vials | Class II | Terminated |
| D-1148-2018 | 08-02-2018 | Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 864 vials | Class II | Terminated |
| D-1582-2019 | 08-01-2018 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11 Package NDCs: 62584-693-11; 62584-693-21 | Failed Dissolution Specifications: Out of specification result for the dissolution test. | American Health Packaging / 6,579 cartons | Class II | Terminated |
| D-1046-2018 | 08-01-2018 | Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30 | Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months. | Akorn, Inc. / 22,605 tubes | Class II | Terminated |
| D-1035-2018 | 08-01-2018 | Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24. Package NDCs: 36000-045-01; 36000-046-24; 36000-047-24; 36000-048-24 | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Baxter Healthcare Corporation / 106,320 bags | Class III | Terminated |
| D-1036-2018 | 08-01-2018 | Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24. Package NDCs: 36000-045-01; 36000-046-24; 36000-047-24; 36000-048-24 | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Baxter Healthcare Corporation / 711,216 bags | Class III | Terminated |
| D-1034-2018 | 08-01-2018 | Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24. Package NDCs: 36000-045-01; 36000-046-24; 36000-047-24; 36000-048-24 | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Baxter Healthcare Corporation / 191,256 bags | Class III | Terminated |
| D-1026-2018 | 07-30-2018 | Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04 Package NDCs: 0904-0430-95; 0904-0430-04; 0904-0430-06 | Failed Dissolution Specifications | MAJOR PHARMACEUTICALS / 3,161 Cartons | Class II | Terminated |
| D-1037-2018 | 07-30-2018 | Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | NuCare Pharmaceuticals Inc / N/A | Class II | Terminated |
| D-1039-2018 | 07-30-2018 | Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | NuCare Pharmaceuticals Inc / N/A | Class II | Terminated |
| D-1038-2018 | 07-30-2018 | Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | NuCare Pharmaceuticals Inc / N/A | Class II | Terminated |
| D-1027-2018 | 07-27-2018 | Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Bryant Ranch Prepack Inc. / 690 tablets | Class II | Terminated |
| D-1029-2018 | 07-27-2018 | Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. Package NDCs: 71335-0567-1; 71335-0567-2; 71335-0567-3; 71335-0567-4 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Bryant Ranch Prepack Inc. / 90 tablets | Class II | Terminated |
| D-1028-2018 | 07-27-2018 | Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Bryant Ranch Prepack Inc. / 990 tablets | Class II | Terminated |
| D-1022-2018 | 07-26-2018 | Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side. | Carcinogen impurity detected in API used to manufacture drug product. | H J Harkins Company Inc dba Pharma Pac / 540 tablets | Class II | Terminated |
| D-1047-2018 | 07-26-2018 | Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361 | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label | Right Value Drug Stores, Inc. / 4800 pellets | Class III | Terminated |
| D-1050-2018 | 07-26-2018 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01 Package NDCs: 68180-422-01 | Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study. | Lupin Pharmaceuticals Inc. / 13,896 bottles | Class III | Terminated |
| D-1075-2018 | 07-25-2018 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23 Package NDCs: 0037-0245-23 | Presence of foreign substance: Potential for glass in the neck area of the glass bottles. | Mylan Pharmaceuticals Inc. / 20,780 bottles | Class II | Terminated |
| D-1092-2018 | 07-25-2018 | PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 vial | Class II | Terminated |
| D-1093-2018 | 07-25-2018 | P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 vial | Class II | Terminated |
| D-1089-2018 | 07-25-2018 | Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 droptainer | Class II | Terminated |
| D-1090-2018 | 07-25-2018 | P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 2 vials | Class II | Terminated |
| D-1082-2018 | 07-25-2018 | Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 213 prefilled syringes | Class II | Terminated |
| D-1091-2018 | 07-25-2018 | PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 vial | Class II | Terminated |
| D-1085-2018 | 07-25-2018 | Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 60 vials | Class II | Terminated |
| D-1087-2018 | 07-25-2018 | Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 2 vials | Class II | Terminated |
| D-1094-2018 | 07-25-2018 | Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 2 vials | Class II | Terminated |
| D-1086-2018 | 07-25-2018 | Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / a) 2 vials; b) 1 vial | Class II | Terminated |
| D-1080-2018 | 07-25-2018 | Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 5 droptainers | Class II | Terminated |
| D-1083-2018 | 07-25-2018 | Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / a) 1 vial; b) 1 vial | Class II | Terminated |
| D-1081-2018 | 07-25-2018 | DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 droptainer | Class II | Terminated |
| D-1084-2018 | 07-25-2018 | PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 vial | Class II | Terminated |
| D-1088-2018 | 07-25-2018 | Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. | Ranier's Compounding Laboratory / 1 droptainer | Class II | Terminated |
| D-1078-2018 | 07-25-2018 | alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5 | Microbial Contamination of a Non-Sterile Product | The Hain Celestial Group, Inc. - Worldwide HQ / 1,098 tubes | Class II | Terminated |
| D-1025-2018 | 07-24-2018 | Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05. Package NDCs: 0143-2112-50; 0143-2112-05; 0143-2112-20 | Failed Dissolution Specifications: | West-Ward Columbus Inc / 29048 500-count bottles (14,524,000 tablets) | Class II | Terminated |
| D-1024-2018 | 07-24-2018 | Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50. Package NDCs: 0143-2112-50; 0143-2112-05; 0143-2112-20 | Failed Dissolution Specifications: | West-Ward Columbus Inc / 29,048 bottles (1,452,400 tablets) | Class II | Terminated |
| D-1042-2018 | 07-24-2018 | Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08. | Defective Container: Tamper Evident foil seal not completely intact. | Morton Grove Pharmaceuticals, Inc. / 38,280 bottles | Class II | Terminated |
| D-1044-2018 | 07-24-2018 | 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC. | CGMP deviations: Product was released while a hood certification discrepancy was being investigated. | PharMEDium Services, LLC / 450 Syringes | Class II | Terminated |
| D-1045-2018 | 07-24-2018 | 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC. | CGMP deviations: Product was released while a hood certification discrepancy was being investigated. | PharMEDium Services, LLC / 575 Syringes | Class II | Terminated |
| D-1043-2018 | 07-24-2018 | 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC. | CGMP deviations: Product was released while a hood certification discrepancy was being investigated. | PharMEDium Services, LLC / 230 Intravia Bags | Class II | Terminated |
| D-0646-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Acid Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955512721, NDC 57955-5227-2 | Microbial contamination | King Bio Inc. / 322 bottles | Class I | Terminated |
| D-0945-2019 | 07-20-2018 | NET Remedies #5 Fire Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4205-2 | Microbial contamination | King Bio Inc. / 19490 bottles | Class I | Terminated |
| D-0756-2019 | 07-20-2018 | Dr. King's SafeCare Rx Environmental Adaptation Cold/Damp, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955028420, NDC 57955-0284-2 | Microbial contamination | King Bio Inc. / 25 bottles | Class I | Terminated |
| D-0877-2019 | 07-20-2018 | Dr. King's SafeCare Rx Hangover Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955011323, NDC 57955-0113-2 | Microbial contamination | King Bio Inc. / 90 bottles | Class I | Terminated |
| D-0911-2019 | 07-20-2018 | NET Remedies #1 Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428 Hume Street, Toowoomba QLD 4350, Australia | Microbial contamination | King Bio Inc. / 2600 bottles | Class I | Terminated |
| D-0985-2019 | 07-20-2018 | Dr. King's SafeCare Rx Breast Cyst & Discomforts High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955000327, NDC 57955-0003-2 | Microbial contamination | King Bio Inc. / 162 bottles | Class I | Terminated |
| D-0667-2019 | 07-20-2018 | Dr. King's Natural Medicine for kids! Attention & Learning Enhancement Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955501527, NDC 57955-5015-2 | Microbial contamination | King Bio Inc. / 1083 bottles | Class I | Terminated |
| D-0752-2019 | 07-20-2018 | Dr. King's SafeCare Rx Sluggish Mind Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955152026, NDC 57955-1521-2 | Microbial contamination | King Bio Inc. / 101 bottles | Class I | Terminated |
| D-0647-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Caffeine Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955540229, NDC 57955-6202-2 | Microbial contamination | King Bio Inc. / 19 bottles | Class I | Terminated |
| D-0834-2019 | 07-20-2018 | Dr. King's SafeCare Rx Acid Clenz, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955012726, NDC 57955-0127-2 | Microbial contamination | King Bio Inc. / 133 bottles | Class I | Terminated |
| D-0690-2019 | 07-20-2018 | Dr. King's SafeCare Rx Teething Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955001829, NDC 57955-0018-2 | Microbial contamination | King Bio Inc. / 100 bottles | Class I | Terminated |
| D-0535-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Regional Allergies Great Lakes U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955519027, NDC 57955-8195-2 | Microbial contamination | King Bio Inc. / 4499 bottles | Class I | Terminated |
| D-0528-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Regional Allergies Pacific U.S. 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955519324, NDC 57955-8198-2 | Microbial contamination | King Bio Inc. / 6210 bottles | Class I | Terminated |
| D-0650-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Mood Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955503729, NDC 57955-5037-2 | Microbial contamination | King Bio Inc. / 31 bottles | Class I | Terminated |
| D-0571-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Hemorrhoid Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955502326, NDC 57955-5023-2 | Microbial contamination | King Bio Inc. / 2045 bottles | Class I | Terminated |
| D-0600-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Sciatic Nerve Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955503026, NDC 57955-6030-2 | Microbial contamination | King Bio Inc. / 14978 bottles | Class I | Terminated |
| D-0607-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Headache Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955515326, NDC 57955-5153-2 | Microbial contamination | King Bio Inc. / 1046 bottles | Class I | Terminated |
| D-0557-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Advanced Arnica, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955598428, NDC 57955-5984-2 | Microbial contamination | King Bio Inc. / 11055 bottles | Class I | Terminated |
| D-0602-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic No Sweat Anti-Perspirant, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955508526, NDC 57955-5085-2 | Microbial contamination | King Bio Inc. / 181 bottles | Class I | Terminated |
| D-0556-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Anxiety & Nervousness, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955516323, NDC 57955-5163-2 | Microbial contamination | King Bio Inc. / 21925 bottles | Class I | Terminated |
| D-0895-2019 | 07-20-2018 | Dr. King's SafeCare Rx Foul Bowel, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955031925, NDC 57955-0319-2 | Microbial contamination | King Bio Inc. / 15 bottles | Class I | Terminated |
| D-0775-2019 | 07-20-2018 | Dr. King's SafeCare Rx CS-Bone, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021124, NDC 57955-0211-2 | Microbial contamination | King Bio Inc. / 18 bottles | Class I | Terminated |
| D-0749-2019 | 07-20-2018 | Dr. King's SafeCare Rx Cold Sores & Herpes Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955016526, NDC 57955-0165-2 | Microbial contamination | King Bio Inc. / 783 bottles | Class I | Terminated |
| D-0881-2019 | 07-20-2018 | Dr. King's SafeCare Rx Shy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955275022, NDC 57955-2751-2 | Microbial contamination | King Bio Inc. / 13 bottles | Class I | Terminated |
| D-0614-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Food Chemical Intolerances, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955504221, NDC 57955-0728-2 | Microbial contamination | King Bio Inc. / 1326 bottles | Class I | Terminated |
| D-0861-2019 | 07-20-2018 | Dr. King's SafeCare Rx Allergy & Red Eye Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955016427, NDC 57955-0164-2 | Microbial contamination | King Bio Inc. / 288 bottles | Class I | Terminated |
| D-0972-2019 | 07-20-2018 | Dr. King's SafeCare Rx Aller-Detox: Outdoor Pollution Control Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955240426, NDC 57955-2404-2 | Microbial contamination | King Bio Inc. / 98 bottles | Class I | Terminated |
| D-0984-2019 | 07-20-2018 | Dr. King's SafeCare Rx Aversion to Change High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955280026, NDC 57955-2800-2 | Microbial contamination | King Bio Inc. / 48 bottles | Class I | Terminated |
| D-0870-2019 | 07-20-2018 | Dr. King's SafeCare Rx Aller-Detox: Indoor Pollution Control, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955240129, NDC 57955-2408-2 | Microbial contamination | King Bio Inc. / 57 bottles | Class I | Terminated |
| D-0748-2019 | 07-20-2018 | Dr. King's SafeCare Rx Fears & Nightmares Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955181026, NDC 57955-1811-2 | Microbial contamination | King Bio Inc. / 96 bottles | Class I | Terminated |
| D-0624-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Bug Away, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955507727, NDC 57955-5077-2 | Microbial contamination | King Bio Inc. / 349 bottles | Class I | Terminated |
| D-0564-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Hangover Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955511328, NDC 57955-5113-2 | Microbial contamination | King Bio Inc. / 309 bottles | Class I | Terminated |
| D-0596-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Sore Throat & Laryngitis, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955505822, NDC 57955-5058-2 | Microbial contamination | King Bio Inc. / 6028 bottles | Class I | Terminated |
| D-0777-2019 | 07-20-2018 | Dr. King's SafeCare Rx Sore Throat & Laryngitis, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955005827, NDC 57955-0137-2 | Microbial contamination | King Bio Inc. / 340 bottles | Class I | Terminated |
| D-0560-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Yeast Freee, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955507628, NDC 57955-5076-2 | Microbial contamination | King Bio Inc. / 2433 bottles | Class I | Terminated |
| D-0903-2019 | 07-20-2018 | Dr. King's Aquaflora Enzyme Restoration Upper GI Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955232124, NDC 57955-3321-2 | Microbial contamination | King Bio Inc. / 2634 bottles | Class I | Terminated |
| D-0542-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Gallbladder Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955506829, NDC 57955-6058-2 | Microbial contamination | King Bio Inc. / 1735 bottles | Class I | Terminated |
| D-0615-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Fever Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955516026, NDC 57955-5160-2 | Microbial contamination | King Bio Inc. / 285 bottles | Class I | Terminated |
| D-0681-2019 | 07-20-2018 | Dr. King's SafeCare Rx Colic Relief Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955015826, NDC 57955-0178-2 | Microbial contamination | King Bio Inc. / 40 bottles | Class I | Terminated |
| D-0674-2019 | 07-20-2018 | Dr. King's Natural Medicine Kids Multi-Strain Flu Relief Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955042228, NDC 57955-0422-2 | Microbial contamination | King Bio Inc. / 3271 bottles | Class I | Terminated |
| D-0640-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Ileocecal Valve Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955509820, NDC 57955-6083-2 | Microbial contamination | King Bio Inc. / 500 bottles | Class I | Terminated |
| D-0595-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Sporting Edge, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955503125, NDC 57955-5031-2 | Microbial contamination | King Bio Inc. / 51 bottles | Class I | Terminated |
| D-0709-2019 | 07-20-2018 | Dr. King's SafeCare Rx UlcerPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955175025, NDC 57955-0188-2 | Microbial contamination | King Bio Inc. / 24 bottles | Class I | Terminated |
| D-0639-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Indigestion Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955502425, NDC 57955-5024-2 | Microbial contamination | King Bio Inc. / 479 bottles | Class I | Terminated |
| D-0904-2019 | 07-20-2018 | Aquaflora Heavy Metal Detox Candida, 2 fl. oz. (59 mL), Homeopathic, King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 USA, NDC 57955-2281-2 | Microbial contamination | King Bio Inc. / 2086 bottles | Class I | Terminated |
| D-0977-2019 | 07-20-2018 | Dr. King's Bronchial Care, 59 mL (liquid/liquid), Manufactured by: King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 Imported by Ambiental Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80035774 UPC 357955180425 | Microbial contamination | King Bio Inc. / 1807 bottles | Class I | Terminated |
| D-0886-2019 | 07-20-2018 | Dr. King's SafeCare Rx GynePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955000723, NDC 57955-0007-2 | Microbial contamination | King Bio Inc. / 95 bottles | Class I | Terminated |
| D-0731-2019 | 07-20-2018 | Dr. King's SafeCare Rx SYP Miasm Constitution, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955030324, NDC 57955-0306-2 | Microbial contamination | King Bio Inc. / 85 bottles | Class I | Terminated |
| D-0898-2019 | 07-20-2018 | Dr. King's SafeCare Rx CS-Ovary, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021629, NDC 57955-0216-2 | Microbial contamination | King Bio Inc. / 26 bottles | Class I | Terminated |
| D-0955-2019 | 07-20-2018 | NET Remedies #25 Yin/Yang Balance Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4215-2 | Microbial contamination | King Bio Inc. / 5092 bottles | Class I | Terminated |
| D-0831-2019 | 07-20-2018 | Dr. King's SafeCare Rx Allergies: Nuts & Seeds, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955220428, NDC 57955-2204-2 | Microbial contamination | King Bio Inc. / 97 bottles | Class I | Terminated |
| D-0531-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Heart Regularity, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955506522, NDC 57955-5065-2 | Microbial contamination | King Bio Inc. / 478 bottles | Class I | Terminated |
| D-0572-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic PMS Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955500926, NDC 57955-5009-2 | Microbial contamination | King Bio Inc. / 1018 bottles | Class I | Terminated |
| D-0644-2019 | 07-20-2018 | Dr. King's Natural Medicine Homeopathic Birth Ease, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955500223, NDC 57955-5002-2 | Microbial contamination | King Bio Inc. / 89 bottles | Class I | Terminated |
| D-0699-2019 | 07-20-2018 | Dr. King's Natural Medicine Soothing Advanced Arnica Pure Homeopathic Cream, 3 oz. (85 g), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955400035, NDC 57955-4000-3 | Microbial contamination | King Bio Inc. / 17527 tubes | Class I | Terminated |
| D-0914-2019 | 07-20-2018 | NET Remedies #12 Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428 Hume Street, Toowoomba QLD 4350, Australia | Microbial contamination | King Bio Inc. / 2100 bottles | Class I | Terminated |
| D-0701-2019 | 07-20-2018 | Dr. King's SafeCare Rx CS-Uterus Cancer Support, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955022121, NDC 57955-0247-2 | Microbial contamination | King Bio Inc. / 19 bottles | Class I | Terminated |
