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
Prinston Pharmaceutical Inc
Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunq...
Oral Drugs·2,177 affected·Jan 18, 2019
High RiskFDA
Tris Pharma Inc.
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle...
Oral Drugs·35,328 affected·Jan 15, 2019
High RiskFDA
Tris Pharma Inc.
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ...
Oral Drugs·35,280 affected·Jan 15, 2019
High RiskFDA
Tris Pharma Inc.
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL ...
Oral Drugs·46,080 affected·Jan 15, 2019
High RiskFDA
Lupin Somerset
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD...
Topical Drugs·24,180 affected·Jan 15, 2019
RecallFDA
Lin-zhi International Inc
Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster de...
Diagnostic Devices·49 affected·Jan 11, 2019
High RiskFDA
Major Pharmaceuticals
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17...
Oral Drugs·3,102 affected·Jan 10, 2019
CriticalFDA
Sun Pharmaceutical Industries, Inc.
Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun...
Injectable Drugs·12,534 affected·Jan 3, 2019
CriticalFDA
Sun Pharmaceutical Industries, Inc.
Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun ...
Injectable Drugs·1,384 affected·Jan 3, 2019
High RiskFDA
Pharmedium Services, Llc.
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine...
Drugs·7,711 affected·Jan 2, 2019
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
Oral Drugs·20,604 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08...
Oral Drugs·55,788 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30
Oral Drugs·0 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured ...
Oral Drugs·0 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
Oral Drugs·0 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayto...
Oral Drugs·53,064 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayt...
Oral Drugs·92,616 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 088...
Oral Drugs·27,688 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayt...
Oral Drugs·111,239 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayt...
Oral Drugs·23,016 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08...
Oral Drugs·18,408 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90
Oral Drugs·0 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
Oral Drugs·0 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayt...
Oral Drugs·32,160 affected·Dec 31, 2018
High RiskFDA
Aurobindo Pharma Usa Inc.
Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08...
Oral Drugs·60,417 affected·Dec 31, 2018
High RiskFDA
Lupin Somerset
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Ma...
Oral Drugs·23,460 affected·Dec 21, 2018
CriticalFDA
Lupin Pharmaceuticals Inc.
Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 6818...
Injectable Drugs·12,000 affected·Dec 20, 2018
CriticalFDA
Lupin Pharmaceuticals Inc.
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 6818...
Injectable Drugs·8,000 affected·Dec 20, 2018
High RiskFDA
Torrent Pharma Inc.
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indra...
Oral Drugs·43,416 affected·Dec 20, 2018
CriticalFDA
Lupin Pharmaceuticals Inc.
Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-6...
Injectable Drugs·35,000 affected·Dec 20, 2018
High RiskFDA
Torrent Pharma Inc.
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-...
Oral Drugs·83,016 affected·Dec 20, 2018
CriticalFDA
Lupin Pharmaceuticals Inc.
Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmace...
Injectable Drugs·3,792 affected·Dec 20, 2018
High RiskFDA
Allergan, Plc.
OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvi...
Drugs·133,716 affected·Dec 20, 2018
High RiskFDA
Torrent Pharma Inc.
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (N...
Oral Drugs·18,852 affected·Dec 20, 2018
High RiskFDA
Torrent Pharma Inc.
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC...
Oral Drugs·18,780 affected·Dec 20, 2018
High RiskFDA
Torrent Pharma Inc.
LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bot...
Oral Drugs·65,832 affected·Dec 20, 2018
RecallFDA
Cbi Laboratories, Inc.
Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
Drugs·5,363 affected·Dec 10, 2018
RecallFDA
Cbi Laboratories, Inc.
Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Ski...
Drugs·2,055 affected·Dec 10, 2018
High RiskFDA
Gordon Laboratories
Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon L...
Drugs·1,155 affected·Dec 10, 2018
RecallFDA
Sun Pharmaceutical Industries, Inc.
Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Res...
Oral Drugs·47,520 affected·Dec 7, 2018
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, ND...
Oral Drugs·1,996 affected·Dec 6, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05...
Oral Drugs·32,284 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05...
Oral Drugs·22,813 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-...
Oral Drugs·50,595 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·129,754 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 265...
Oral Drugs·119,761 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,...
Oral Drugs·76,516 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·232,180 affected·Dec 4, 2018