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 the agency’s own highest classification or reported deaths or serious injuries, 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

14751–14775 of 18042

ModerateFDA (Drugs)·D-0245-2015·2014-11-19
Fougera Recalls Fluocinonide Gel Due to Residual Solvent Concerns
Fougera Pharmaceuticals is recalling specific lots of Fluocinonide Gel USP, 0.05% because they may not meet USP requirements for residual solvents.
Product
FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0248-2015·2014-11-19
Assured Naproxen Sodium Tablets Recalled Due to Mispackaging Error
Contract Packaging Resources Inc. is recalling Assured Naproxen Sodium Tablets because correct labeled bottles of Assured Ibuprofen softgels were mistakenly packaged into Naproxen cartons.
Product
Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0246-2015·2014-11-19
Micro Labs Recalls Simvastatin Tablets Due to Impurity Specification Failure
Micro Labs USA Inc. is recalling 1,008 bottles of Simvastatin Tablets, 10 mg, because the product failed impurity content specifications.
Product
Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-0247-2015·2014-11-19
Fresenius Kabi Recalls Haloperidol Decanoate Injection Due to Impurity Failure
Fresenius Kabi is recalling Haloperidol Decanoate Injection vials due to an out-of-specification impurity result. The recall covers 216,517 vials distributed nationwide and in Puerto Rico.
Product
HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0179-2015·2014-11-12
FDA Recalls Calcium Chloride Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling specific lots of Calcium Chloride Injectable due to quality control issues affecting sterility assurance identified during an FDA inspection.
Product
CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0193-2015·2014-11-12
Gentamicin Sulfate Irrigation Solution Recalled for Sterility Assurance Concerns
Oregon Compounding Centers is recalling Gentamicin Sulfate irrigation solution due to quality control issues affecting sterility assurance identified during an FDA inspection.
Product
GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0197-2015·2014-11-12
Hyaluronidase Injectable Recalled Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling hyaluronidase injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Product
HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0223-2015·2014-11-12
FDA Recalls Compounded Testosterone Cypionate Injectable Due to Sterility Concerns
Oregon Compounding Centers is recalling compounded Testosterone Cypionate injectable vials due to quality control issues affecting sterility assurance.
Product
TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0210-2015·2014-11-12
FDA Recalls Compounded Injectable Drug Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling specific lots of a compounded injectable drug due to quality control issues affecting sterility assurance.
Product
PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0192-2015·2014-11-12
Gentamicin Sulfate Irrigation Solution Recalled for Sterility Assurance Concerns
Creative Compounds is recalling Gentamicin Sulfate irrigation solution due to quality control issues affecting sterility assurance identified during an FDA inspection.
Product
GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0220-2015·2014-11-12
Procaine HCL Injectable Recall Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Procaine HCL injectable vials due to quality control issues affecting sterility assurance.
Product
PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0215-2015·2014-11-12
FDA Recalls Papaverine, Phentolamine, and Alprostadil Injectable Due to Sterility Concerns
Oregon Compounding Centers is recalling specific lots of a sterile injectable drug due to quality control issues that may compromise sterility.
Product
PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0175-2015·2014-11-12
Recall of Injectable Ascorbic Acid Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling injectable Ascorbic Acid (Vitamin B) due to quality control issues affecting sterility assurance identified during an FDA inspection.
Product
ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0183-2015·2014-11-12
Renacidin Solution Recalled for Sterility Assurance Concerns
Oregon Compounding Centers is recalling Renacidin solution due to quality control issues affecting sterility assurance identified during an FDA inspection.
Product
CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0218-2015·2014-11-12
FDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Papaverine/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance.
Product
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0187-2015·2014-11-12
FDA Recalls DMPS Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling DMPS injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Product
DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0199-2015·2014-11-12
FDA Recalls Hydroxocobalamin Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Hydroxocobalamin injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Product
HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0194-2015·2014-11-12
FDA Recalls Sterile Glutaraldehyde Solution Due to Quality Control Concerns
Oregon Compounding Centers is recalling sterile glutaraldehyde solution for irrigation due to quality control issues affecting sterility assurance.
Product
GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0177-2015·2014-11-12
FDA Recalls AVASTIN Syringes Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling AVASTIN syringes because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.
Product
AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0202-2015·2014-11-12
Recall of Injectable Methylcobalamin Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling injectable Methylcobalamin due to quality control issues affecting sterility assurance.
Product
METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0208-2015·2014-11-12
FDA Recalls Compounded Omnipaque Injectable Due to Sterility Concerns
Oregon Compounding Centers is recalling compounded Omnipaque injectable vials due to quality control issues affecting sterility assurance.
Product
OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0174-2015·2014-11-12
FDA Recalls Alprostadil/Lidocaine Vials Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Alprostadil/Lidocaine HCL vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Product
ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0189-2015·2014-11-12
FDA Recalls Estradiol Cypionate Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Estradiol Cypionate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Product
ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0200-2015·2014-11-12
Hydroxyprogesterone Caproate Injectable Recalled for Sterility Assurance Concerns
Oregon Compounding Centers is recalling Hydroxyprogesterone Caproate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Product
HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0212-2015·2014-11-12
FDA Recalls Sterile Injectable Drug Due to Quality Control Concerns
Oregon Compounding Centers is recalling sterile injectable drug vials due to quality control issues affecting sterility assurance.
Product
PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Category
Drug
Distribution
2 states

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14751–14775 of 18042