Hazard Type

Product Quality Recalls

2,865 product recalls involving product quality. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

2,865Total Recalls
260Critical
322.2MUnits Affected
All Recalls

Every Product Quality Recall

Sorted by most recent. Click any recall for full details and safety information.

2,865 recalls
RecallFDA
Akorn, Inc.
Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use V...
Injectable Drugs·8,187 affected·Aug 6, 2019
RecallFDA
Akorn, Inc.
Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc....
Injectable Drugs·648 affected·Aug 6, 2019
High RiskFDA
Imprimisrx Nj
Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 We...
Ophthalmic Drugs·246 affected·Jul 17, 2019
High RiskFDA
Imprimisrx Nj
Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledge...
Ophthalmic Drugs·405 affected·Jul 17, 2019
High RiskFDA
Tris Pharma Inc.
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg ...
Drugs·2,550 affected·Jul 11, 2019
High RiskFDA
Piramal Critical Care, Inc.
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Pri...
Injectable Drugs·2,155 affected·Jul 8, 2019
High RiskFDA
Lupin Pharmaceuticals Inc.
Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distri...
Oral Drugs·12,938 affected·Jul 2, 2019
CriticalFDA
Fresenius Kabi Usa, Llc
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 ...
Injectable Drugs·14,016 affected·Jun 28, 2019
High RiskFDA
Inter-med Llc
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Medical Devices·768 affected·Jun 27, 2019
High RiskFDA
Inter-med Llc
Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
Medical Devices·582 affected·Jun 27, 2019
High RiskFDA
Inter-med Llc
Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
Medical Devices·445 affected·Jun 27, 2019
High RiskFDA
Inter-med Llc
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Medical Devices·1,992 affected·Jun 27, 2019
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufacture...
Oral Drugs·4,277 affected·Jun 20, 2019
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsb...
Oral Drugs·142,626 affected·Jun 20, 2019
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured b...
Oral Drugs·47,520 affected·Jun 20, 2019
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plains...
Oral Drugs·29,106 affected·Jun 20, 2019
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plain...
Oral Drugs·145,162 affected·Jun 20, 2019
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10
Oral Drugs·1,470 affected·Jun 14, 2019
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30
Oral Drugs·4,037 affected·Jun 14, 2019
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90
Oral Drugs·32,835 affected·Jun 14, 2019
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90
Oral Drugs·14,955 affected·Jun 14, 2019
High RiskFDA
B. Braun Medical Inc
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun...
Injectable Drugs·40,176 affected·Jun 13, 2019
High RiskFDA
Teva Pharmaceuticals Usa
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
Oral Drugs·2,924,000 affected·Jun 6, 2019
High RiskFDA
Teva Pharmaceuticals Usa
LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
Oral Drugs·2,943,000 affected·Jun 6, 2019
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS ...
Oral Drugs·17,136 affected·Jun 5, 2019
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Ph...
Oral Drugs·9,528 affected·Jun 5, 2019
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distribut...
Oral Drugs·17,904 affected·Jun 5, 2019
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-count box. Distrib...
Oral Drugs·14,399 affected·Jun 5, 2019
High RiskFDA
Chiesi Usa, Inc.
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 6699...
Oral Drugs·2,598 affected·May 31, 2019
High RiskFDA
Chiesi Usa, Inc.
ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10...
Oral Drugs·2,118 affected·May 31, 2019
High RiskFDA
Medline Industries, Inc.
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP C...
Cardiac Devices·14,550 affected·May 30, 2019
High RiskFDA
Medline Industries Inc
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular devic...
Surgical Devices·0 affected·May 28, 2019
High RiskFDA
Medline Industries Inc
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular dev...
Surgical Devices·330 affected·May 28, 2019
RecallFDA
Fresenius Kabi Usa, Llc
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
Injectable Drugs·11,981 affected·May 22, 2019
RecallFDA
Teligent Pharma, Inc.
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx On...
Topical Drugs·9,360 affected·May 20, 2019
High RiskFDA
Geritrex, Llc
Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54...
Drugs·24,312 affected·May 6, 2019
High RiskFDA
Geritrex, Llc
Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, N...
Drugs·1,536 affected·May 6, 2019
High RiskFDA
Heritage Pharmaceuticals, Inc.
Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102,...
Oral Drugs·25,220 affected·May 3, 2019
High RiskFDA
Heritage Pharmaceuticals, Inc.
Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102,...
Oral Drugs·34,403 affected·May 3, 2019
High RiskFDA
Heritage Pharmaceuticals, Inc.
Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 1...
Oral Drugs·15,541 affected·May 3, 2019
High RiskFDA
Heritage Pharmaceuticals, Inc.
Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot N...
Oral Drugs·3,697 affected·May 3, 2019
High RiskFDA
Heritage Pharmaceuticals, Inc.
Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. ...
Oral Drugs·3,012 affected·May 3, 2019
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated
Oral Drugs·11,668 affected·May 1, 2019
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated
Oral Drugs·11,286 affected·May 1, 2019
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated
Oral Drugs·8,767 affected·May 1, 2019
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
Oral Drugs·138,213 affected·May 1, 2019
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated
Oral Drugs·64,362 affected·May 1, 2019
High RiskFDA
Direct Rx
Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
Drugs·33 affected·Apr 30, 2019