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
Mylan Laboratories Limited, (nashik Fdf)
Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-0...
Oral Drugs·32,696 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,...
Oral Drugs·141,995 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., ...
Oral Drugs·109,314 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-...
Oral Drugs·19,352 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 265...
Oral Drugs·160,300 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,...
Oral Drugs·84,066 affected·Dec 4, 2018
High RiskFDA
Vistapharm, Inc.
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 ...
Oral Drugs·4,065,550 affected·Nov 30, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Man...
Oral Drugs·120,394 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Man...
Oral Drugs·75,883 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Ma...
Oral Drugs·142,260 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (N...
Oral Drugs·31,079 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Ma...
Oral Drugs·39,617 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (...
Oral Drugs·19,458 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (N...
Oral Drugs·37,957 affected·Nov 27, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles ...
Oral Drugs·41,572 affected·Nov 27, 2018
High RiskFDA
Tris Pharma Inc.
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bott...
Oral Drugs·164,304 affected·Nov 26, 2018
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 O...
Oral Drugs·19,488 affected·Nov 26, 2018
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·20,736 affected·Nov 26, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc...
Oral Drugs·12,336 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, In...
Oral Drugs·48,302 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc...
Oral Drugs·23,478 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·25,147 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 265...
Oral Drugs·63,213 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·12,840 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharm...
Oral Drugs·5,660 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·24,709 affected·Nov 20, 2018
RecallFDA
Takeda Development Center Americas, Inc.
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda...
Oral Drugs·69,075 affected·Nov 6, 2018
High RiskFDA
Golden State Medical Supply Inc.
IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: S...
Oral Drugs·12,502 affected·Nov 2, 2018
High RiskFDA
Golden State Medical Supply Inc.
IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: S...
Oral Drugs·15,917 affected·Nov 2, 2018
High RiskFDA
Golden State Medical Supply Inc.
IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by...
Oral Drugs·2,439 affected·Nov 2, 2018
High RiskFDA
Sandoz, Inc
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufact...
Oral Drugs·170 affected·Nov 1, 2018
High RiskFDA
Sciegen Pharmaceuticals Inc
Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manu...
Oral Drugs·2,977 affected·Oct 29, 2018
High RiskFDA
Sciegen Pharmaceuticals Inc
GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactur...
Oral Drugs·18,760 affected·Oct 29, 2018
High RiskFDA
Sciegen Pharmaceuticals Inc
Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Ma...
Oral Drugs·5,061 affected·Oct 29, 2018
High RiskFDA
Sciegen Pharmaceuticals Inc
GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed...
Oral Drugs·3,835 affected·Oct 29, 2018
High RiskFDA
Westminster Pharmaceuticals Llc
Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: We...
Oral Drugs·1,571 affected·Oct 29, 2018
RecallFDA
Akorn, Inc.
Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 28...
Topical Drugs·58,393 affected·Oct 29, 2018
High RiskFDA
Sciegen Pharmaceuticals Inc
GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufacture...
Oral Drugs·30,194 affected·Oct 29, 2018
High RiskFDA
Westminster Pharmaceuticals Llc
Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: W...
Oral Drugs·3,976 affected·Oct 29, 2018
High RiskFDA
Sciegen Pharmaceuticals Inc
Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manuf...
Oral Drugs·5,989 affected·Oct 29, 2018
High RiskFDA
Westminster Pharmaceuticals Llc
Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: W...
Oral Drugs·2,319 affected·Oct 29, 2018
High RiskFDA
Aurobindo Pharma Limited (unit I)
Irbesartan Bulk Active Pharmaceutical Ingredient.
Drugs·1,724 affected·Oct 24, 2018
High RiskFDA
Taro Pharmaceuticals U.s.a., Inc.
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distr...
Oral Drugs·8,328 affected·Oct 19, 2018
High RiskFDA
Taro Pharmaceuticals U.s.a., Inc.
children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle,...
Oral Drugs·0 affected·Oct 19, 2018
High RiskFDA
Taro Pharmaceuticals U.s.a., Inc.
Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bot...
Oral Drugs·12,432 affected·Oct 19, 2018
High RiskFDA
H J Harkins Company Inc Dba Pharma Pac
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Drugs·84 affected·Oct 18, 2018
High RiskFDA
Lannett Company, Inc.
HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company,...
Oral Drugs·8,324 affected·Oct 11, 2018
High RiskFDA
Akorn, Inc.
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 1...
Ophthalmic Drugs·149,159 affected·Oct 8, 2018