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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 61–80 of 208 recalls

VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com

Boulla LLC

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

November 4, 2024 · DrugView details →

PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com

Boulla LLC

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

November 4, 2024 · DrugView details →

Class IOngoing

ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com

Boulla LLC

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

November 4, 2024 · DrugView details →

Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.

123Herbals

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.

September 18, 2024 · DrugView details →

Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04

Baxter Healthcare Corporation

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

August 1, 2024 · DrugView details →

0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.

B. Braun Medical Inc

Presence of Particulate Matter

July 24, 2024 · DrugView details →

Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.

MAIN PRODUCTS INC

Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.

July 18, 2024 · DrugView details →

Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199

Supercore Products Group Inc.

Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.

July 12, 2024 · DrugView details →

Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.

SoloVital

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.

July 12, 2024 · DrugView details →

Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.

Supercore Products Group Inc.

Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.

July 12, 2024 · DrugView details →

Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21.

Aurobindo Pharma USA Inc

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

July 11, 2024 · DrugView details →

Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01

Hikma Pharmaceuticals USA Inc.

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)

July 8, 2024 · DrugView details →

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.

Amerisource Health Services LLC

Failed Dissolution Specifications

June 25, 2024 · DrugView details →

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05

Glenmark Pharmaceuticals Inc., USA

Failed Dissolution Specifications

May 30, 2024 · DrugView details →

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01

Glenmark Pharmaceuticals Inc., USA

Failed Dissolution Specifications

May 30, 2024 · DrugView details →

Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

Sagent Pharmaceuticals

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

May 28, 2024 · DrugView details →

Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

Sagent Pharmaceuticals

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

May 28, 2024 · DrugView details →

suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187

SYNCHRONICITY SPA INC, DBA SUNTE

Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)

May 24, 2024 · DrugView details →

Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64

Revive Rx LLC dba Revive Rx Pharmacy

Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate

April 20, 2024 · DrugView details →

Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.

Dr. Reddy's Laboratories, Inc.

Sub-potent Drug; powder discoloration associated with decreased potency

April 8, 2024 · DrugView details →

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