Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-11-13FDA-DrugBasic Reset Inc.Class IIBasic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
Marketed without an Approved NDA/ANDA
- 2019-11-13FDA-DrugBasic Reset Inc.Class IIBasic 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
Marketed without an Approved NDA/ANDA
- 2019-11-13FDA-DrugBasic Reset Inc.Class IIBasic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
Marketed without an Approved NDA/ANDA
- 2019-11-13FDA-DrugBasic Reset Inc.Class IIBasic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
Marketed without an Approved NDA/ANDA
- 2019-11-13FDA-DrugBasic Reset Inc.Class IINuovi 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
Marketed without an Approved NDA/ANDA
- 2019-11-13FDA-DrugBasic Reset Inc.Class IIBasic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075
Marketed without an Approved NDA/ANDA
- 2019-11-13FDA-DrugBasic Reset Inc.Class IIMiracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN.
Marketed without an Approved NDA/ANDA
- 2019-11-13FDA-DrugBasic Reset Inc.Class IIBasic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, TN 37075.
Marketed without an Approved NDA/ANDA
- 2019-11-13FDA-DrugMylan Pharmaceuticals Inc.Class IIAlprazolam 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
Presence of Foreign Substance
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC.
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRanitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-11-06FDA-DrugFITOTERAPIA USA, INCClass IMero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave. 112 Pembroke Pines, FL 33028
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
- 2019-11-06FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIChildren'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
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- 2019-11-06FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIChildren'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
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
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