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

9101–9125 of 17772

ModerateFDA (Drugs)·D-0014-2019·2018-10-17
Syntec Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels
Syntec Pharma Corp is recalling 486 kg of Thyroid Powder USP because the active ingredients levothyroxine and liothyronine have inconsistent levels.
Product
THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 8.1-9.9mcg/grain) active pharmaceutical ingredient; 25 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hon
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0012-2019·2018-10-17
InvaGen Recalls Amlodipine Besylate Tablets Due to Subpotency
InvaGen Pharmaceuticals is recalling one lot of Amlodipine Besylate 10 mg tablets because the product failed to meet assay specifications at 3-month stability conditions.
Product
AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0013-2019·2018-10-17
Syntec Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels
Syntec Pharma Corp is recalling 5 KG bags of Thyroid Powder USP because the active ingredients levothyroxine and liothyronine have inconsistent levels.
Product
THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient; 5 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0026-2019·2018-10-17
Takeda Recalls Actoplus met XR Tablets Due to Defective Delivery System
Takeda is recalling Actoplus met XR tablets because the laser-drilled holes on the metformin core may be missing, potentially affecting drug delivery.
Product
Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30
Category
Drug
Distribution
9 states
LowFDA (Drugs)·D-0016-2019·2018-10-17
Xiromed Recalls Altavera Tablets Due to Generic Name Mislabeling
Xiromed LLC is recalling Altavera tablets because the generic name on the packaging may cause confusion. The FDA classifies this as a Class III recall.
Product
ALTAVERA — ALTAVERA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0005-2019·2018-10-10
Pfizer Recalls Elelyso Vials Due to Sterility Assurance Concerns
Pfizer is recalling 12,416 vials of Elelyso (taliglucerase alfa) because loose metal ferrule crimps may compromise sterility.
Product
ELELYSO — ELELYSO (TALIGLUCERASE ALFA)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0001-2019·2018-10-10
Teva Recalls Clozapine Tablets Due to Failed Disintegration Testing
Teva Pharmaceuticals is recalling 313 bottles of Clozapine 12.5 mg tablets because routine stability testing showed the tablets failed to disintegrate as required.
Product
CLOZAPINE — CLOZAPINE (CLOZAPINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0007-2019·2018-10-10
Dr. Reddy's Recalls Nystatin and Triamcinolone Cream for Stability Failures
Dr. Reddy's Laboratories is recalling Nystatin and Triamcinolone Acetonide Cream because stability testing showed out-of-specification results for Nystatin composition.
Product
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ -
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0002-2019·2018-10-10
BioLyte Recalls NeoRelief Topical Gel Due to Ingredient Contamination
BioLyte Laboratories is recalling NeoRelief topical gel because it contains active ingredients that were previously recalled for water contamination.
Product
NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS — NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS (TOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESS)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0006-2019·2018-10-10
Sichuan Friendly Pharmaceutical Recalls Thyroid Powder Due to CGMP Deviations
Sichuan Friendly Pharmaceutical Co., Ltd. is recalling Thyroid Powder 25kg/drum because the product has inconsistent levels of active ingredients.
Product
Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0009-2019·2018-10-10
Endo Pharmaceuticals Recalls Robaxin-750 Due to Incorrect Dosage Labeling
Endo Pharmaceuticals is recalling 2,856 bottles of Robaxin-750 (methocarbamol) because the labels contain incorrect dosage instructions.
Product
robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0017-2019·2018-10-10
Otsuka Recalls Mislabeled treatNOW Abilify Physician Sample Kits
Otsuka is recalling 17,325 treatNOW Abilify physician sample kits due to labeling errors, including misspelled product names and missing storage instructions.
Product
treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Di
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0018-2019·2018-10-10
Otsuka Recalls Mislabeled Abilify and Abilify Maintena Physician Sample Kits
Otsuka is recalling 4,738 physician sample kits of Abilify and Abilify Maintena due to labeling errors, including misspelled product names and missing storage instructions.
Product
treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0081-2019·2018-10-03
Hetero Labs Recalls Montelukast Sodium Tablets Due to Labeling Error
Hetero Labs Limited is recalling 98,016 bottles of Montelukast Sodium 10 mg tablets because one lot may contain Losartan Potassium 50 mg tablets.
Product
MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1209-2018·2018-10-03
Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defect
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.
Product
MINIVELLE — MINIVELLE (ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1217-2018·2018-10-03
Boehringer Ingelheim Recalls SYNJARDY Tablets Due to Cross Contamination
Boehringer Ingelheim is recalling 998 bottles of SYNJARDY tablets due to cross-contamination with other products.
Product
SYNJARDY — SYNJARDY (EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1215-2018·2018-10-03
Baxter Recalls Levofloxacin Injection Bags Due to High Potency
Baxter Healthcare is recalling 523,896 bags of Levofloxacin Injection in 5% Dextrose because the drug concentration was higher than specified.
Product
LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1208-2018·2018-10-03
Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defect
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.
Product
MINIVELLE — MINIVELLE (ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1211-2018·2018-10-03
Fenofibrate Tablets Recalled Due to Foreign Valacyclovir Tablet Presence
Hetero Labs is recalling Fenofibrate 145 mg tablets because a foreign Valacyclovir 500 mg tablet was found in the bottles.
Product
FENOFIBRATE — FENOFIBRATE (FENOFIBRATE)
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-1213-2018·2018-10-03
Hetero Recalls Montelukast Sodium Tablets Due to Blue Specks
Hetero Labs Limited is recalling 98,016 bottles of Montelukast Sodium 10 mg tablets because a pharmacist reported blue specks on the tablets.
Product
MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1210-2018·2018-10-03
Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defects
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.
Product
MINIVELLE — MINIVELLE (ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1207-2018·2018-10-03
Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defect
Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.
Product
MINIVELLE — MINIVELLE (ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0103-2019·2018-10-03
Dr. Reddy's Recalls Zoledronic Acid Injection Due to Unknown Impurities
Dr. Reddy's Laboratories is recalling Zoledronic Acid Injection vials because they failed impurity specifications with out-of-specification unknown impurities.
Product
ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0104-2019·2018-10-03
Dr. Reddy's Recalls Zoledronic Acid Injection Due to Unknown Impurities
Dr. Reddy's Laboratories is recalling 10,530 vials of Zoledronic Acid Injection because of out-of-specification unknown impurities.
Product
ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
Category
Drug
Distribution
0 states
CriticalFDA (Drugs)·D-0003-2019·2018-09-26
QuVa Pharma Recalls Subpotent Norepinephrine IV Bags Nationwide
QuVa Pharma is recalling 528 bags of Norepinephrine 4 mg in 5% Dextrose because the active ingredient may be missing. The product was distributed to hospitals nationwide.
Product
Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
Category
Drug
Distribution
Distributed nationwide

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9101–9125 of 17772