Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

8801–8825 of 17772

SevereFDA (Drugs)·D-0306-2019·2018-12-19
Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 10 mg/320 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
Product
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, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0314-2019·2018-12-19
Mylan Recalls Valsartan Tablets Due to NDEA Impurity
Mylan Pharmaceuticals is recalling Valsartan tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA). The affected product was distributed throughout the United States.
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0311-2019·2018-12-19
Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.
Product
AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0305-2019·2018-12-19
Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Teva Pharmaceuticals USA is recalling specific lots of Amlodipine and Valsartan Tablets 5 mg/320 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
Product
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, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0331-2019·2018-12-19
Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Mylan is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).
Product
VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0329-2019·2018-12-19
Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Mylan is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.
Product
VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0317-2019·2018-12-19
Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Mylan Pharmaceuticals is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).
Product
VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0300-2019·2018-12-19
Westminster Irbesartan Tablets Recalled Due to NDEA Impurity
Westminster Pharmaceuticals is recalling specific lots of Irbesartan tablets because FDA testing found traces of the NDEA impurity.
Product
Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-119-01; b) 90 count bottle NDC 69367-119-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0328-2019·2018-12-19
Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Mylan is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient.
Product
VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0304-2019·2018-12-19
Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Teva Pharmaceuticals USA is recalling specific lots of Amlodipine and Valsartan Tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).
Product
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, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0318-2019·2018-12-19
Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.
Product
AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0308-2019·2018-12-19
Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Teva Pharmaceuticals USA is recalling specific bottles of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).
Product
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMAC
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0320-2019·2018-12-19
Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Mylan is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient.
Product
AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0332-2019·2018-12-19
Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Mylan is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity NDEA in the active ingredient.
Product
VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0303-2019·2018-12-19
Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 5 mg/160 mg because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
Product
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, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0326-2019·2018-12-19
Mylan Recalls Valsartan Tablets Due to NDEA Impurity
Mylan is recalling Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA). The product was distributed throughout the United States.
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0301-2019·2018-12-19
Westminster Irbesartan Tablets Recalled Due to NDEA Impurity Traces
Westminster Pharmaceuticals is recalling specific lots of Irbesartan Tablets because FDA testing found traces of the NDEA impurity.
Product
Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-120-01; b) 90 count bottle NDC 69367-120-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0324-2019·2018-12-19
Mylan Recalls Valsartan Tablets Due to NDEA Impurity
Mylan is recalling specific lots of Valsartan 40 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0313-2019·2018-12-19
Mylan Recalls Valsartan Tablets Due to NDEA Impurity
Mylan Pharmaceuticals is recalling Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA). The affected product was distributed throughout the United States.
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0316-2019·2018-12-19
Mylan Recalls Valsartan Tablets Due to NDEA Impurity
Mylan Pharmaceuticals is recalling specific lots of Valsartan 320 mg tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0323-2019·2018-12-19
Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Mylan is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity NDEA in the active ingredient.
Product
AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0294-2019·2018-12-19
Dr. Reddy's Recalls Clopidogrel Tablets Due to Dissolution Failure
Dr. Reddy's Laboratories is recalling specific lots of Clopidogrel Bisulfate 300 mg tablets because they failed dissolution specifications during stability testing.
Product
CLOPIDOGREL BISULFATE — CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0293-2019·2018-12-19
CAO Group Recalls FastStat Topical Hemostat Kits Due to cGMP Violations
CAO Group, Inc. is recalling FastStat Topical Hemostat Introductory Kits because cGMP violations were noted during the firm's most recent inspection.
Product
FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0292-2019·2018-12-19
CAO Group Recalls BeeGentle Topical Anesthetic Due to cGMP Violations
CAO Group, Inc. is recalling BeeGentle Honey Flavored Topical Anesthetic because of current Good Manufacturing Practice (cGMP) violations found during a recent FDA inspection.
Product
BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Me
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0290-2019·2018-12-19
CAO Group Recalls fas.TRACT Hemostatic Gel Due to cGMP Violations
CAO Group, Inc. is recalling fas.TRACT Coagulative Hemostatic Gel kits due to current Good Manufacturing Practice (cGMP) violations identified during a recent inspection.
Product
fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
Category
Drug
Distribution
Distributed nationwide

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8801–8825 of 17772