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

7851–7875 of 8593

SevereFDA (Drugs)·D-820-2013·2013-07-31
Astellas Recalls AmBisome Injection Lots Due to Sterility Concerns
Astellas Pharma US is voluntarily recalling specific lots of AmBisome (amphotericin B) liposome for injection because a routine simulation detected bacterial contamination.
Product
AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-809-2013·2013-07-31
Mobius Recalls Mitosol Ophthalmic Kits Due to Yeast Contamination
Mobius Therapeutics is recalling 83 boxes of Mitosol ophthalmic kits because components were found to be contaminated with yeast.
Product
MITOSOL — MITOSOL (MITOMYCIN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-825-2013·2013-07-31
West-Ward Recalls Belladonna Alkaloids Tablets Due to Cross-Contamination
West-Ward Pharmaceutical Corp. is recalling Belladonna Alkaloids with Phenobarbital Tablets because they contain a trace amount of Methocarbamol.
Product
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-799-2013·2013-07-24
Arm & Hammer Sodium Bicarbonate Powder Recalled for Contamination
Church & Dwight is recalling Arm & Hammer Sodium Bicarbonate Powder due to the presence of stainless steel and other foreign substances.
Product
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 3 Fine Powdered, Net Wt. 50 lbs. (22.68 kg.) per
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-806-2013·2013-07-24
Apotex Recalls Piperacillin and Tazobactam Injection Due to Crystallization Risk
Apotex Corp. is recalling 37,303 vials of Piperacillin and Tazobactam for Injection due to a risk of precipitation or crystallization in IV bags or lines.
Product
Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-804-2013·2013-07-24
Fresenius Kabi Recalls Subpotent Oxytocin Injection Vials
Fresenius Kabi is recalling 221,600 vials of Oxytocin Injection, USP, due to a subpotent drug issue identified during a 15-month stability test.
Product
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-805-2013·2013-07-24
Sandoz Recalls Estarylla Contraceptive Tablets Due to Placebo Tablet Error
Sandoz Incorporated is recalling Estarylla tablets because a placebo tablet was found in a row of active tablets, which could reduce contraceptive effectiveness.
Product
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-767-2013·2013-07-17
Olympia Pharmacy Recalls Pento-Gluc Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Pento-Gluc 200 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Product
Pento-Gluc 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-692-2013·2013-07-17
Olympia Pharmacy Recalls Acetyl-D-Glucosamine Due to Sterility Concerns
Olympia Pharmacy is recalling Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.
Product
Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-720-2013·2013-07-17
Dexpanthenol Injection Recalled for Lack of Sterility Assurance
Olympia Pharmacy is recalling Dexpanthenol 250 mg/ml Injection due to FDA inspection findings regarding quality control and sterility assurance.
Product
Dexpanthenol 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-702-2013·2013-07-17
Olympia Pharmacy Recalls Atropine Sulfate Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Atropine Sulfate 50 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Product
Atropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-701-2013·2013-07-17
Olympia Pharmacy Recalls Atipamezole Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Atipamezole 10 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Product
Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-693-2013·2013-07-17
Olympia Pharmacy Recalls Acepromazine Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Acepromazine 25 mg/ml Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.
Product
Acepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-760-2013·2013-07-17
Olympia Pharmacy Recalls MICC Injections Due to Sterility Concerns
Olympia Pharmacy is recalling MICC and MICC 25/50/330 injections because FDA inspections raised concerns about quality control and sterility assurance.
Product
MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 25/50/330 Inj, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-793-2013·2013-07-17
Olympia Pharmacy Recalls Vitamin B-Buildup Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Vitamin B-Buildup Injection because FDA inspections raised concerns about quality control and sterility assurance.
Product
Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-751-013·2013-07-17
Olympia Pharmacy Recalls Medroxyprogesterone Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Medroxyprogesterone 150 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.
Product
Medroxyprogesterone 150 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-737-2013·2013-07-17
Olympia Pharmacy Recalls Compounded Guanabenz Injection Due to Sterility Concerns
Olympia Pharmacy is recalling three vials of compounded Guanabenz 8 mg/ml Injection due to FDA inspection findings regarding quality control and sterility assurance.
Product
Guanabenz 8 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-757-2013·2013-07-17
Olympia Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns
Olympia Pharmacy is recalling two lots of compounded Methylcobalamin injections nationwide and in Puerto Rico due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Product
Methylcobalamin 25 mg/ml Inj and 5000 mcg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-721-2013·2013-07-17
Olympia Pharmacy Recalls Dextrose 50% Solution Due to Sterility Concerns
Olympia Pharmacy is recalling Dextrose 50% Solution because FDA inspections raised concerns about quality control and sterility assurance.
Product
Dextrose 50% Solution, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-780-2013·2013-07-17
Olympia Pharmacy Recalls Sodium Iodide 20% Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Sodium Iodide 20% Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Product
Sodium Iodide 20% Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-783-2013·2013-07-17
Olympia Pharmacy Recalls Stanozolol Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Stanozolol injections because FDA inspections raised concerns about quality control and sterility assurance.
Product
Stanozolol (50 mg/ml and 100 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-776-2013·2013-07-17
Olympia Pharmacy Recalls Compounded Progesterone Injection Due to Sterility Concerns
Olympia Pharmacy is recalling compounded Progesterone 100 mg/ml in Olive Oil Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Product
Progesterone 100 mg/ml in Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-750-2013·2013-07-17
Olympia Pharmacy Recalls Medetomidine Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Medetomidine 2 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.
Product
Medetomidine 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-742-2013·2013-07-17
Olympia Pharmacy Recalls Idoxuridine Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Idoxuridine 0.1% Injection because FDA inspections raised concerns about quality control and sterility assurance.
Product
Idoxuridine 0.1% Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-698-2013·2013-07-17
Aminocaproic Acid Injection Recalled for Sterility Concerns
Olympia Pharmacy is recalling Aminocaproic Acid 250 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Product
Aminocaproic Acid 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Category
Drug
Distribution
Distributed nationwide

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