Drug Recalls

Drug Recall Results

Boulla LLC – Marketed as Dietary Supplement

Date: 11/05/2024
Company: Boulla LLC
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Sildenafil and Diclofenac

AK Forte – AK Forte Dietary Supplement

Date: 10/16/2024
Company: C&A Naturistics
Dosage Form: Other / Unspecified
Recall Issue Type: Other Recall Issue
Recall Reason: Device & Drug Safety – Unapproved Drug

STASKA Pharmaceuticals – Ascorbic Acid Solution for Injection

Date: 10/16/2024
Company: STASKA Pharmaceuticals Inc.
Dosage Form: Injection, Solution
Recall Issue Type: Other Recall Issue
Recall Reason: Device & Drug Safety – Presence of glass particulates

Gilead – Veklury (remdesivir) for Injection

Date: 09/23/2024
Company: Gilead Sciences, Inc.
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Due to Presence of Glass Particle

BionPharma – Atovaquone Oral Suspension, 750 mg/mL

Date: 09/18/2024
Company: Bionpharma Inc.
Dosage Form: Suspension
Recall Issue Type: Other Recall Issue
Recall Reason: Product found to be contaminated with Cohnella bacteria

B Braun – 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers

Date: 08/08/2024
Company: B. Braun Medical Inc.
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Potential for particulate matter and fluid leakage of the containers

Baxter – Heparin Sodium in 0.9% Sodium Chloride Injection

Date: 08/06/2024
Company: Baxter International Inc
Dosage Form: Injection
Recall Issue Type: Quality / Potency
Recall Reason: Elevated endotoxin levels

Healthy Living – Migraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets

Date: 07/24/2024
Company: Aurobindo Pharma USA, Inc.
Dosage Form: Tablet
Recall Issue Type: Labeling / Packaging
Recall Reason: Device & Drug Safety - Mislabeling

Umary – Umary Acido Hialuronico, Suplemento Alimenticio

Date: 07/22/2024
Company: Main Products, Inc.
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Drug Ingredients: Diclofenac and Omeprazole

Hikma – Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL

Date: 07/22/2024
Company: Hikma Pharmaceuticals PLC
Dosage Form: Injection
Recall Issue Type: Labeling / Packaging
Recall Reason: Potential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL).

Par Pharmaceutical – Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets

Date: 07/17/2024
Company: Endo USA, Inc
Dosage Form: Tablet
Recall Issue Type: Labeling / Packaging
Recall Reason: Mislabeled with the incorrect strength on the carton

Infla-650 – Infla-650 Herbal Dietary Supplement Capsules

Date: 07/16/2024
Company: Guru Inc.
Dosage Form: Capsule
Recall Issue Type: Other Recall Issue
Recall Reason: Tainted with the drug ingredients: acetaminophen, diclofenac and phenylbutazone

Umary – Umary Acido Hialuronica, Suplemento Alimenticio – 30 Capletas de 850mg

Date: 07/15/2024
Company: SoloVital.com
Dosage Form: Other / Unspecified
Recall Issue Type: Other Recall Issue
Recall Reason: Tainted with the drug ingredients, diclofenac and omeprazole

Supercore Products Group – Dietary Supplements for Male Sexual Enhancement.

Date: 07/12/2024
Company: Supercore Products Group
Dosage Form: Other / Unspecified
Recall Issue Type: Other Recall Issue
Recall Reason: Tainted with Sildenafil and Acetaminophen.

Blue Point Laboratories – Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count

Date: 06/26/2024
Company: American Health Packaging
Dosage Form: Capsule
Recall Issue Type: Quality / Potency
Recall Reason: Failed dissolution

Glenmark – Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count

Date: 06/25/2024
Company: Glenmark Pharmaceuticals, Inc.
Dosage Form: Capsule
Recall Issue Type: Quality / Potency
Recall Reason: Failed dissolution

Ram It, To The Moon – Dietary Supplements for Male Sexual Enhancement

Date: 06/11/2024
Company: Integrity Products
Dosage Form: Other / Unspecified
Recall Issue Type: Other Recall Issue
Recall Reason: Product is tainted with sildenafil and tadalafil

StellaLife Inc. – Homeopathic StellaLife Oral Care Products

Date: 06/05/2024
Company: HomeoCare Laboratories Inc.
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Microbial contamination

Sagent – Docetaxel Injection, USP

Date: 05/29/2024
Company: Sagent Pharmaceuticals
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Potential presence of particulate matter

Hospira – Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units

Date: 05/22/2024
Company: Hospira Inc.
Dosage Form: Injection
Recall Issue Type: Labeling / Packaging
Recall Reason: Device & Drug Safety – Potential Packaging Defect