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

6976–7000 of 11856

SevereFDA (Drugs)·D-0461-2017·2017-02-08
VistaPharm Recalls Nystatin Oral Suspension Due to Water Contamination
VistaPharm is recalling Nystatin Oral Suspension because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
Product
Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0449-2017·2017-02-08
Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures
Dr. Reddy's Laboratories is recalling Flucanazole tablets because they failed dissolution and stability specifications.
Product
FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0466-2017·2017-02-08
VistaPharm Recalls Methadone Hydrochloride Due to Potential Bacterial Contamination
VistaPharm is recalling Methadone Hydrochloride Oral Concentrate because purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
Product
METHADONE HYDROCHLORIDE — METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0467-2017·2017-02-08
VistaPharm Recalls Methadone Hydrochloride Oral Concentrate Due to Water Contamination
VistaPharm is recalling 3,354 bottles of Methadone Hydrochloride Oral Concentrate because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
Product
Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0458-2017·2017-02-08
VistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Contamination
VistaPharm is recalling Hydrocodone Bitartrate and Acetaminophen Oral Solution because purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
Product
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx o
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0464-2017·2017-02-08
VistaPharm Recalls Oxycodone Hydrochloride Oral Solution Due to Water Contamination
VistaPharm is recalling Oxycodone Hydrochloride Oral Solution because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
Product
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0450-2017·2017-02-08
Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures
Dr. Reddy's is recalling Flucanazole tablets that failed dissolution and stability specifications. Patients should stop using the affected lots and consult their healthcare provider.
Product
FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0465-2017·2017-02-08
VistaPharm Recalls Methadone Hydrochloride Due to Potential Bacterial Contamination
VistaPharm is recalling Methadone Hydrochloride Oral Concentrate because purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
Product
METHADONE HYDROCHLORIDE — METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0459-2017·2017-02-08
VistaPharm Recalls Metoclopramide Oral Solution Due to Potential Water Contamination
VistaPharm is recalling specific lots of Metoclopramide Oral Solution because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
Product
Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0428-2017·2017-01-18
Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling 1,068,600 Daytrana transdermal patches nationwide because the delivery system failed mechanical peel force specifications.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0430-2017·2017-01-18
Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the delivery system failed to meet mechanical peel force specifications.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0368-2017·2017-01-11
Wells Pharmacy Recalls MIC/B12 Injectable Vials Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 633 vials of MIC/B12 Injectable due to a lack of assurance of sterility. The affected products were distributed nationwide.
Product
MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0391-2017·2017-01-11
Wells Pharmacy Recalls Sermorelin Injectable Kits Due to Sterility Concerns
Wells Pharmacy is recalling Sermorelin Acetate/GHRP (2) Injectable Kits because the agency could not ensure the product was sterile.
Product
Sermorelin Acetate/GHRP (2) 9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0271-2017·2017-01-11
Tri-Coast Pharmacy Recalls Lipotropic with MIC Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 236 vials of Lipotropic with MIC compounded between May and November 2016 due to a lack of assurance of sterility.
Product
Lipotropic with MIC (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/L-Carnitine 170 mg + Methylcopalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-Phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 20mg/ml, (30 ML). Compound
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0336-2017·2017-01-11
FDA Recalls Compounded HCG Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 10 kits of compounded Chorionic Gonadotropin (HCG) injectable kits due to a lack of assurance of sterility.
Product
Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0366-2017·2017-01-11
Wells Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 265 vials of compounded Methylcobalamin 5,000 mcg/mL Injectable because the product lacks assurance of sterility.
Product
Methylcobalamin 5,000 mcg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0292-2017·2017-01-11
Tri-Coast Pharmacy Recalls Sermorelin Forte Plus Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 441 vials of Sermorelin Forte Plus 18 mg because the products lack assurance of sterility. The recall covers sterile products compounded between May 17, 2016, and November 17, 2016.
Product
Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0333-2017·2017-01-11
Wells Pharmacy Recalls NADH Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling NADH injectable compounded in Ocala, FL, due to a lack of assurance of sterility.
Product
Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0312-2017·2017-01-11
Tri-Coast Pharmacy Recalls TriMix Injections Due to Sterility Concerns
Tri-Coast Pharmacy is recalling TriMix compounded injections because the agency could not ensure the products were sterile.
Product
TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0301-2017·2017-01-11
Tri-Coast Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 1,544 vials of compounded Testosterone Cypionate/Zinc Gluconate in Sesame Oil nationwide due to a lack of assurance of sterility.
Product
Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0401-2017·2017-01-11
Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 146 vials of compounded Testosterone Cypionate Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Testosterone Cypionate in Grapeseed Oil Injectable, 20 mg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0327-2017·2017-01-11
Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
Wells Pharmacy is recalling Testosterone Cypionate in Grapeseed Oil Injectable vials because the product lacks assurance of sterility. The recall covers vials prepared between February 2016 and September 2016.
Product
Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0265-2017·2017-01-11
Tri-Coast Pharmacy Recalls IV Cocktail #2 Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 132 vials of IV Cocktail #2 nationwide due to a lack of assurance of sterility.
Product
IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL), (30 ML). Compounded by Tri-Co
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0379-2017·2017-01-11
Wells Pharmacy Recalls Mitomycin Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Mitomycin 20 mg kits nationwide due to a lack of assurance of sterility.
Product
Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0284-2017·2017-01-11
Tri-Coast Pharmacy Recalls Quad Mix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Quad Mix compounded injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.
Product
Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide

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6976–7000 of 11856