Drug and pharmaceutical recalls

17707 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 II
Basic 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 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
Presence of Foreign Substance
2019-11-13FDA-DrugDr. Reddy's Laboratories, Inc.Class II
Ranitidine 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 II
Ranitidine 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 II
Ranitidine 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 II
Dr. 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 II
Dr. 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 II
Dr. 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 II
Ranitidine 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 II
Ranitidine 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 II
Ranitidine 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 II
Ranitidine 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 II
Ranitidine 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 II
Ranitidine 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 II
Ranitidine 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 II
Ranitidine 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 II
Ranitidine 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 II
Ranitidine 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 II
Ranitidine 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 II
Dr. 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 I
Mero 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 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
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 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
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 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
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 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
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 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
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
2019-11-06FDA-DrugArbor Pharmaceuticals Inc.Class 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
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
2019-11-06FDA-DrugAuroMedics Pharma LLCClass 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
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
2019-11-06FDA-DrugAVKARE Inc.Class II
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
2019-11-06FDA-DrugAVKARE Inc.Class II
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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