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

5726–5750 of 11856

SevereFDA (Drugs)·D-0307-2019·2018-12-19
Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Teva Pharmaceuticals USA is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).
Product
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0322-2019·2018-12-19
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 ingredient.
Product
AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
Category
Drug
Distribution
1 state
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-0330-2019·2018-12-19
Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Mylan Laboratories 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-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
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
SevereFDA (Drugs)·D-0359-2019·2018-12-05
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets Recalled for NDEA Impurity
Sandoz is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.
Product
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0287-2019·2018-12-05
Ascend Recalls Quetiapine Tablets Due to Metal Shard Contamination
Ascend Laboratories is recalling Quetiapine 400 mg tablets because a metal shard was found in a tablet. Patients should stop using the affected lot and contact their healthcare provider.
Product
QUETIAPINE — QUETIAPINE (QUETIAPINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0285-2019·2018-12-05
Germ Bloc Health Hand Sanitizer Foam Recalled for Pseudomonas Contamination
AVKARE Inc. is recalling specific lots of Germ Bloc Health Hand Sanitizer Foam due to the presence of Pseudomonas aeruginosa.
Product
Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0269-2019·2018-11-28
Sciegen Recalls Irbesartan Tablets Due to NDEA Impurity
Sciegen Pharmaceuticals is recalling Irbesartan 300mg tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).
Product
Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in t
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0264-2019·2018-11-28
Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity
Golden State Medical Supply is recalling Irbesartan 150 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).
Product
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: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0271-2019·2018-11-28
Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity
Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 150 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
Product
GSMS 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 ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0270-2019·2018-11-28
Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity
Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 75 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
Product
GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0265-2019·2018-11-28
Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity
Golden State Medical Supply is recalling 12,502 bottles of Irbesartan 300 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).
Product
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: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0272-2019·2018-11-28
Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity
Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, USP, 300 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
Product
GSMS 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 ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0263-2019·2018-11-28
FDA Recalls Irbesartan Tablets Due to NDEA Impurity
Golden State Medical Supply Inc. is recalling 2,439 bottles of Irbesartan 75 mg tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).
Product
IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0268-2019·2018-11-28
Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity
Sciegen Pharmaceuticals is recalling Irbesartan Tablets, 150 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
Product
Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made i
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0267-2019·2018-11-28
Sciegen Recalls Irbesartan Tablets Due to NDEA Impurity
Sciegen Pharmaceuticals is recalling Westminister Irbesartan Tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).
Product
Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0266-2019·2018-11-28
L. Perrigo Recalls Calcium Carbonate Antacid Tablets Due to Metal Particles
L. Perrigo is recalling specific lots of calcium carbonate antacid tablets because they were found to contain metal particles.
Product
Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-72, Distributed by DZA Brands, LLC, Salisbury, NC 28147, Scarborough, ME 04074], [HealthMart Pharmacy brand NDC: 62011-0295-1, Distributed by McKessen, One Post
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0288-2019·2018-11-21
Euphoric Male Performance Enhancer Recalled for Undeclared Prescription Drugs
Epic Products, LLC is recalling Euphoric Premium Male Performance Enhancer capsules because they contain undeclared sildenafil, tadalafil, and oxytetracycline.
Product
Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0246-2019·2018-11-21
Zero Xtreme Dietary Supplement Recalled for Undeclared Sibutramine
Zero Xtreme USA is recalling 16 bottles of Zero Xtreme Dietary Supplement capsules because they contain undeclared sibutramine and were marketed without an approved NDA or ANDA.
Product
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0259-2019·2018-11-21
Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination
Sandoz Inc. is recalling Isosorbide Dinitrate Tablets 5 mg due to cross-contamination with other products. The recall affects 7,817 bottles distributed nationwide.
Product
Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0276-2019·2018-11-21
Taro Recalls Children's Allergy Solution Due to Impurity
Taro Pharmaceuticals is recalling 12,432 bottles of Children's 24 Hour Allergy Oral Solution because an unknown impurity exceeded limits during stability testing.
Product
Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.
Category
Drug
Distribution
Distributed nationwide

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5726–5750 of 11856