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FDA Recalls
›Drug Recalls

FDA Drug Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 321–340 of 1,000 recalls

Class ITerminated

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.

Hikma Pharmaceuticals USA Inc.

Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

December 17, 2019 · DrugView details →

Class ITerminated

Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80

Lannett Company, Inc.

Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.

December 6, 2019 · DrugView details →

Class ITerminated

Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05

AuroMedics Pharma LLC

Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

November 20, 2019 · DrugView details →

Class ITerminated

Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05

AuroMedics Pharma LLC

Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

November 20, 2019 · DrugView details →

Class ITerminated

Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.

Natures Rx

Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.

November 13, 2019 · DrugView details →

Class ITerminated

Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Ten pack capsules per carton, Exclusively Manufactured by: Medicine Man Distribution, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783

Med Man Distribution, Inc.

Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.

November 8, 2019 · DrugView details →

Class ITerminated

UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.

Med Man Distribution, Inc.

Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.

November 8, 2019 · DrugView details →

Class ITerminated

0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25

ICU Medical Inc

Presence of Particulate Matter.

October 25, 2019 · DrugView details →

Class ITerminated

LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03

ICU Medical Inc

Presence of Particulate Matter.

October 25, 2019 · DrugView details →

Class ITerminated

Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 (949) 426-8622.

Green Lumber Holdings, LLC

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.

October 22, 2019 · DrugView details →

Class ITerminated

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

FITOTERAPIA USA, INC

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

September 16, 2019 · DrugView details →

Class ITerminated

Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02

Shire Human Genetic Therapies, Inc.

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

September 12, 2019 · DrugView details →

Class ITerminated

Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02

Shire Human Genetic Therapies, Inc.

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

September 12, 2019 · DrugView details →

Class ITerminated

Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02

Shire Human Genetic Therapies, Inc.

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

September 12, 2019 · DrugView details →

Class ITerminated

Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02

Shire Human Genetic Therapies, Inc.

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

September 12, 2019 · DrugView details →

Class ITerminated

Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707

Darmerica, LLC

Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.

September 6, 2019 · DrugView details →

Class ITerminated

Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.

August 30, 2019 · DrugView details →

Class ITerminated

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43

Jubilant Cadista Pharmaceuticals, Inc.

Failed dissolution specifications : failed results at the 3-month stability time point.

July 9, 2019 · DrugView details →

Class ITerminated

Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]

Fresenius Kabi USA, LLC

Presence of Particulate Matter; glass particulates

June 28, 2019 · DrugView details →

Class ITerminated

Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78

PharMEDium Services, LLC

Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite

June 7, 2019 · DrugView details →

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