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
High RiskFDA
Quva Pharma, Inc.
fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar L...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 7...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suit...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 700...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Sui...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar L...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free,...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Preservative Free, Rx...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Fr...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma ...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX ...
Drugs·0 affected·Nov 12, 2019
High RiskFDA
Quva Pharma, Inc.
fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pha...
Drugs·0 affected·Nov 12, 2019
RecallFDA
Auromedics Pharma Llc
Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma L...
Injectable Drugs·28,810 affected·Nov 11, 2019
RecallFDA
Auromedics Pharma Llc
Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma L...
Injectable Drugs·29,830 affected·Nov 11, 2019
Medium RiskFDA
Auromedics Pharma Llc
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Phar...
Injectable Drugs·138,720 affected·Nov 11, 2019
High RiskFDA
Golden State Medical Supply Inc.
GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East ...
Oral Drugs·0 affected·Nov 6, 2019
High RiskFDA
Golden State Medical Supply Inc.
GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East ...
Oral Drugs·0 affected·Nov 6, 2019
High RiskFDA
American Health Packaging
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Colu...
Oral Drugs·1,692 affected·Nov 1, 2019
High RiskFDA
Lannett Company, Inc.
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 ...
Oral Drugs·683,149 affected·Oct 28, 2019
High RiskFDA
Novitium Pharma Llc
Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jer...
Oral Drugs·2,718 affected·Oct 25, 2019
High RiskFDA
Novitium Pharma Llc
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jers...
Oral Drugs·19,560 affected·Oct 25, 2019
CriticalFDA
Icu Medical Inc
0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25
Injectable Drugs·58,464 affected·Oct 25, 2019
High RiskFDA
Novitium Pharma Llc
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jers...
Oral Drugs·12,312 affected·Oct 25, 2019
High RiskFDA
Novitium Pharma Llc
Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jer...
Oral Drugs·6,660 affected·Oct 25, 2019
CriticalFDA
Icu Medical Inc
LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
Injectable Drugs·389,808 affected·Oct 25, 2019
High RiskFDA
Sanofi-aventis U.s. Llc
Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37...
Oral Drugs·0 affected·Oct 22, 2019
High RiskFDA
Sanofi-aventis U.s. Llc
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.
Drugs·0 affected·Oct 22, 2019
High RiskFDA
Sanofi-aventis U.s. Llc
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 677...
Drugs·0 affected·Oct 22, 2019
High RiskFDA
Sanofi-aventis U.s. Llc
Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-...
Drugs·0 affected·Oct 22, 2019
High RiskFDA
Sanofi-aventis U.s. Llc
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167...
Drugs·0 affected·Oct 22, 2019
High RiskFDA
Sanofi-aventis U.s. Llc
Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 4116...
Drugs·0 affected·Oct 22, 2019
High RiskFDA
Sanofi-aventis U.s. Llc
Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 05...
Drugs·0 affected·Oct 22, 2019
High RiskFDA
Sanofi-aventis U.s. Llc
Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 N...
Drugs·0 affected·Oct 22, 2019
High RiskFDA
Sanofi-aventis U.s. Llc
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.
Drugs·0 affected·Oct 22, 2019
High RiskFDA
Sanofi-aventis U.s. Llc
Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.
Drugs·0 affected·Oct 22, 2019
High RiskFDA
Sanofi-aventis U.s. Llc
Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0...
Drugs·0 affected·Oct 22, 2019
High RiskFDA
Sanofi-aventis U.s. Llc
Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.
Drugs·0 affected·Oct 22, 2019
High RiskFDA
Mylan Pharmaceuticals Inc.
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Oral Drugs·4,272 affected·Oct 18, 2019
High RiskFDA
Avkare Inc.
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pul...
Oral Drugs·7,293 affected·Oct 17, 2019
High RiskFDA
Avkare Inc.
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pul...
Oral Drugs·1,351 affected·Oct 17, 2019
RecallFDA
Amneal Pharmaceuticals, Inc.
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharm...
Oral Drugs·2,460 affected·Oct 16, 2019
High RiskFDA
Ingenus Pharmaceuticals Llc
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. ...
Injectable Drugs·16,485 affected·Oct 9, 2019
High RiskFDA
Mylan Laboratories Limited (sterile Products Division)
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
Injectable Drugs·19,165 affected·Oct 7, 2019
Medium RiskFDA
Sato Pharmaceutical Inc.
Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Sui...
Oral Drugs·210,744 affected·Oct 1, 2019
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (...
Oral Drugs·0 affected·Oct 1, 2019