FDA Recall
Terminated
Historical recordClass II
Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
by Basic Reset Inc.
- Reason
- Marketed without an Approved NDA/ANDA
- Published
- November 13, 2019
- Distribution
- United States including Puerto Rico and…
View recall →
FDA Recall
Terminated
Historical recordClass II
Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
by Basic Reset Inc.
- Reason
- Marketed without an Approved NDA/ANDA
- Published
- November 13, 2019
- Distribution
- United States including Puerto Rico and…
View recall →
FDA Recall
Terminated
Historical recordClass II
Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
by Basic Reset Inc.
- Reason
- Marketed without an Approved NDA/ANDA
- Published
- November 13, 2019
- Distribution
- United States including Puerto Rico and…
View recall →
FDA Recall
Terminated
Historical recordClass II
Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA exclusively for Basic Reset 260 W. Main St., Ste 103 Hendersonville, TN 37075
by Basic Reset Inc.
- Reason
- Marketed without an Approved NDA/ANDA
- Published
- November 13, 2019
- Distribution
- United States including Puerto Rico and…
View recall →
FDA Recall
Terminated
Historical recordClass II
Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075
by Basic Reset Inc.
- Reason
- Marketed without an Approved NDA/ANDA
- Published
- November 13, 2019
- Distribution
- United States including Puerto Rico and…
View recall →
FDA Recall
Terminated
Historical recordClass II
Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN.
by Basic Reset Inc.
- Reason
- Marketed without an Approved NDA/ANDA
- Published
- November 13, 2019
- Distribution
- United States including Puerto Rico and…
View recall →
FDA Recall
Terminated
Historical recordClass II
Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, TN 37075.
by Basic Reset Inc.
- Reason
- Marketed without an Approved NDA/ANDA
- Published
- November 13, 2019
- Distribution
- United States including Puerto Rico and…
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05
by Mylan Pharmaceuticals Inc.
- Reason
- Presence of Foreign Substance
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Images Unlimited Products, dba Cellect Products
- Product
- CELLECT brand and ESSENTIALS FACTOR Cell Synergy brand Unfla…
- Reason
- Product contains unsafe levels of Arsenic and Lead
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
by AuroMedics Pharma LLC
- Reason
- CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
by Innoveix Pharmaceuticals Inc
- Reason
- Lack of Sterility Assurance.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
by Innoveix Pharmaceuticals Inc
- Reason
- Lack of Sterility Assurance.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
by Innoveix Pharmaceuticals Inc
- Reason
- Lack of Sterility Assurance.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01
by Arbor Pharmaceuticals Inc.
- Reason
- Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.
by Sandoz Inc
- Reason
- Labeling: Incorrect or missing package insert.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
Read the full medical disclaimer.