Drug Recalls

Drug Recall Results

Zendedi – dextroamphetamine sulfate tablets, 30 mg

Date: 01/25/2024
Company: Azurity Pharmaceuticals, Inc.
Dosage Form: Tablet
Recall Issue Type: Labeling / Packaging
Recall Reason: Mislabeled package

Robitussin – Cough syrups

Date: 01/24/2024
Company: Haleon
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Microbial Contamination

Multiple brands – Lubricant Eye Drops & Multi-Symptom Eye Drops

Date: 01/22/2024
Company: Kilitch Healthcare India Limited
Dosage Form: Other / Unspecified
Recall Issue Type: Other Recall Issue
Recall Reason: Device & Drug Safety Potential Safety Concerns

Leiters, Compounding Health – Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags

Date: 01/08/2024
Company: Leiters Health
Dosage Form: Other / Unspecified
Recall Issue Type: Quality / Potency
Recall Reason: Potential for superpotent drug

Multiple brands – Lubricant Eye Drops & Multi-Symptom Eye Drops

Date: 11/15/2023
Company: Kilitch Healthcare India Limited
Dosage Form: Other / Unspecified
Recall Issue Type: Other Recall Issue
Recall Reason: Device & Drug Safety Potential Safety Concerns

Rugby – OTC Ophthalmic Sterile Drops

Date: 11/01/2023
Company: The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories
Dosage Form: Other / Unspecified
Recall Issue Type: Other Recall Issue
Recall Reason: Insanitary manufacturing conditions

KVK Tech – Betaxolol Tablets, USP

Date: 10/03/2023
Company: KVK-Tech, Inc.
Dosage Form: Tablet
Recall Issue Type: Other Recall Issue
Recall Reason: Potential Presence of Oxycodone HCl tablet

Hospira – 4.2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection, USP, and 2% Lidocaine HCl Injection, USP

Date: 10/02/2023
Company: Hospira, Inc.
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Potential Presence of Glass Particulates

VistaPharm – Sucralfate Oral Suspension 1g/10mL

Date: 09/22/2023
Company: Potential contamination with Bacillus cereus
Dosage Form: Suspension
Recall Issue Type: Contamination / Sterility
Recall Reason: Potential contamination with Bacillus cereus

Marlex Pharmaceuticals, Inc. – Digoxin Tablets USP, 0.125mg and 0.25mg

Date: 08/31/2023
Company: Marlex Pharmaceuticals, Inc.
Dosage Form: Tablet
Recall Issue Type: Labeling / Packaging
Recall Reason: Label Mix-Up

Major Pharmaceuticals – Dronabinol Capsules 2.5mg and Ziprasidone Hydrochloride Capsules 20mg

Date: 06/14/2023
Company: The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories
Dosage Form: Capsule
Recall Issue Type: Labeling / Packaging
Recall Reason: Packaging may contain incorrect product due to labeling mix-up

Midwest Cleaning Solutions, Clean Pro Supply, SOFT HANDS – Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution; Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution

Date: 03/28/2023
Company: Jarman’s Midwest Cleaning Systems, Inc.
Dosage Form: Solution
Recall Issue Type: Other Recall Issue
Recall Reason: Due to Presence of Methanol

PrimeZEN – PrimeZEN Black 6000 male enhancement capsules

Date: 02/13/2023
Company: Volt Candy
Dosage Form: Capsule
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Product contains undeclared tadalafil and sildenafil

Lupin – Quinapril 20 and 40 mg tablets

Date: 12/21/2022
Company: Lupin Pharmaceuticals Inc.
Dosage Form: Tablet
Recall Issue Type: Other Recall Issue
Recall Reason: Presence of nitrosamine impurity, N-Nitroso-Quinapril

Mylan Institutional LLC – Octreotide Acetate Injection, 500 mcg/mL

Date: 10/25/2022
Company: Mylan Institutional LLC, a Viatris company
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Due to glass particulates

Hospira – Propofol Injection Emulsion, USP

Date: 08/22/2022
Company: Hospira, Inc., a Pfizer Company
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Potential presence of visible particulate

Bryant Ranch Prepack Inc. – Morphine Sulfate 30 mg Extended-Release tablets

Date: 06/29/2022
Company: Bryant Ranch Prepack Inc.
Dosage Form: Tablet
Recall Issue Type: Labeling / Packaging
Recall Reason: Incorrect labeling

Major – Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension

Date: 06/08/2022
Company: Plastikon Healthcare, LLC
Dosage Form: Suspension
Recall Issue Type: Contamination / Sterility
Recall Reason: Due to microbial contamination

Pfizer – Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg

Date: 04/22/2022
Company: Pfizer
Dosage Form: Tablet
Recall Issue Type: Other Recall Issue
Recall Reason: Due to N-Nitroso-Quinapril Content

Auromedics – Polymyxin B for Injection USP, 500,000 Units/Vial

Date: 01/28/2022
Company: AuroMedics Pharma LLC
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Presence of Particulate Matter