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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 21–40 of 433 recalls

Class IICompleted

HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 37419, NDC 86161-210

Zeco LLC

CGMP Deviations: sterile water not used for production

August 5, 2024 · DrugView details →

Class IIICompleted

Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

Amneal Pharmaceuticals, LLC

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

August 1, 2024 · DrugView details →

Class IIICompleted

Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).

Zydus Pharmaceuticals (USA) Inc

Cross contamination with other products

July 2, 2024 · DrugView details →

Class IIICompleted

Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).

Zydus Pharmaceuticals (USA) Inc

Cross contamination with other products

July 2, 2024 · DrugView details →

Class IICompleted

Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

Medisca Inc.

CGMP Deviations and Presence of Particulate Matter: Glass

June 26, 2024 · DrugView details →

Class IICompleted

Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,

Winder Laboratories, LLC

Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

May 28, 2024 · DrugView details →

Class IIICompleted

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05

Hikma Injectables USA Inc

Labeling: Wrong Barcode

April 30, 2024 · DrugView details →

Class IICompleted

Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10

Viatris Inc

Failed Impurities/Degradation Specifications

April 30, 2024 · DrugView details →

Class IICompleted

Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10

Viatris Inc

Failed Impurities/Degradation Specifications

April 30, 2024 · DrugView details →

Class ICompleted

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25

Hikma Injectables USA Inc

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

April 29, 2024 · DrugView details →

Class IIICompleted

Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77

Viatris Inc

Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.

April 25, 2024 · DrugView details →

Class IICompleted

Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.

Coast Quality Pharmacy, LLC dba Anazao Health

Presence of Foreign Substance; Broken metal piece found embedded in tablet.

April 24, 2024 · DrugView details →

Class IICompleted

Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01

Dercher Enterprises, Inc., DBA Gordon Laboratories

cGMP Deviations

April 12, 2024 · DrugView details →

Class IIICompleted

NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03

Esperion

Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.

March 27, 2024 · DrugView details →

Class IICompleted

Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.

Amneal Pharmaceuticals of New York, LLC

Failed Dissolution Specifications

March 25, 2024 · DrugView details →

Class IICompleted

Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01

Eli Lilly & Company

CGMP Deviations

March 12, 2024 · DrugView details →

Class IICompleted

S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03

Specialty Process Labs LLC

Failed Stability Specifications

March 1, 2024 · DrugView details →

Class IICompleted

S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.

Specialty Process Labs LLC

Failed Stability Specifications

March 1, 2024 · DrugView details →

Class IICompleted

Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.

Bausch Health Companies, Inc.

Subpotent Drug: Out of specification for assay

February 2, 2024 · DrugView details →

Class ICompleted

TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Chemical Contamination; presence of benzene.

February 1, 2024 · DrugView details →

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