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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 6661–6680 of 17,773 recalls

Class IICompleted

Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →
Class IICompleted

Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →
Class IICompleted

Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →
Class IICompleted

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

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →
Class IICompleted

Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →
Class IICompleted

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC.

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →
Class IICompleted

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

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →
Class IITerminated

Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy

New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Lack of sterility assurance.

October 1, 2019 · DrugView details →
Class IIITerminated

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

Arbor Pharmaceuticals Inc.

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

September 27, 2019 · DrugView details →
Class IITerminated

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

Taro Pharmaceuticals U.S.A., Inc.

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

September 27, 2019 · DrugView details →
Class IITerminated

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

Taro Pharmaceuticals U.S.A., Inc.

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

September 27, 2019 · DrugView details →
Class IITerminated

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

Taro Pharmaceuticals U.S.A., Inc.

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

September 27, 2019 · DrugView details →
Class IITerminated

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

Taro Pharmaceuticals U.S.A., Inc.

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

September 27, 2019 · DrugView details →
Class IITerminated

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

Taro Pharmaceuticals U.S.A., Inc.

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

September 27, 2019 · DrugView details →
Class IITerminated

Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01

Epic Pharma, LLC

Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.

September 26, 2019 · DrugView details →
Class IITerminated

Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed by: Alkermes, Inc. Kit NDC: 65757-300-01

Alkermes, Inc.

Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.

September 26, 2019 · DrugView details →
Class IICompleted

Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00

Apotex Inc.

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

September 24, 2019 · DrugView details →
Class IIITerminated

Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10

Amneal Pharmaceuticals, Inc.

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

September 24, 2019 · DrugView details →
Class IICompleted

Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716

Apotex Inc.

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

September 24, 2019 · DrugView details →
Class IICompleted

Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011

Apotex Inc.

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

September 24, 2019 · DrugView details →
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