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

10226–10250 of 17987

ModerateFDA (Drugs)·D-0199-2018·2018-01-17
KRS Global Biotechnology Recalls Trimix #23F Due to Incorrect Expiration Date
KRS Global Biotechnology is recalling 94 vials of Trimix #23F because the product's expiration date exceeds the expiration date of at least one ingredient.
Product
Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0203-2018·2018-01-17
KRS Global Biotechnology Recalls Vitamin 9 Vials Due to Labeling Errors
KRS Global Biotechnology is recalling 479 vials of Vitamin 9 Lyophilized Vial due to incorrect or missing lot and expiration dates.
Product
Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0161-2018·2018-01-17
KRS Global Biotechnology Recalls Anastrozole 0.5 mg Capsules for Labeling Errors
KRS Global Biotechnology is recalling 15,700 capsules of Anastrozole 0.5 mg due to incorrect or missing lot and expiration dates.
Product
Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0168-2018·2018-01-17
FDA Recalls Bi-Est Cream Due to Expired Ingredient Dates
KRS Global Biotechnology is recalling 300 jars of Bi-Est Cream because the Beyond Use Date exceeds the expiration date of at least one ingredient.
Product
Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0206-2018·2018-01-17
FDA Recalls 7-Keto DHEA Capsules Due to Expired Ingredient
KRS Global Biotechnology is recalling 7-Keto DHEA 100 mg capsules because the product's expiration date exceeds the expiration date of at least one ingredient.
Product
7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0170-2018·2018-01-17
KRS Global Biotechnology Recalls Chloramphenicol and Amphotericin Otic Powder
KRS Global Biotechnology is recalling 20 jars of Chloramphenicol and Amphotericin Otic Powder because the Beyond Use Date exceeds the expiration of at least one ingredient.
Product
Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0205-2018·2018-01-17
KRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Labeling Errors
KRS Global Biotechnology is recalling 5,786 vials of Vitamin 10 B Lyophilized Vial due to incorrect or missing lot and expiration dates.
Product
Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0197-2018·2018-01-17
KRS Global Biotechnology Recalls Sincalide Vials Due to Labeling Errors
KRS Global Biotechnology is recalling 898 vials of Sincalide 5 mcg due to incorrect or missing lot and expiration dates.
Product
Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0186-2018·2018-01-17
KRS Global Biotechnology Recalls Oxytocin IV Bags Due to Labeling Errors
KRS Global Biotechnology is recalling 963 bags of Oxytocin 30 Units IV solution because the Beyond Use Date exceeds the expiration date of at least one ingredient.
Product
Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0213-2018·2018-01-17
Dr. Reddy's Recalls Docetaxel Injection Vials Due to Seal Defects
Dr. Reddy's is recalling 1,051 vials of Docetaxel Injection USP due to defects in the vial seals that may allow the stopper to detach.
Product
DOCETAXEL — DOCETAXEL (DOCETAXEL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0202-2018·2018-01-17
KRS Global Biotechnology Recalls Ophthalmic Solution Due to Labeling Errors
KRS Global Biotechnology is recalling 81 droptainers of a multi-dose ophthalmic solution because the Beyond Use Date exceeds the expiration date of at least one ingredient.
Product
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0187-2018·2018-01-17
KRS Global Biotechnology Recalls Prednisolone Tablets Due to Labeling Errors
KRS Global Biotechnology is recalling 3,000 Prednisolone 10 mg tablets because the expiration date exceeds the stability of an ingredient.
Product
PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0191-2018·2018-01-17
KRS Global Biotechnology Recalls QUADMIX #18 Vials Due to Labeling Errors
KRS Global Biotechnology is recalling 129 vials of QUADMIX #18 because the Beyond Use Date exceeds the expiration date of at least one ingredient.
Product
QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0201-2018·2018-01-17
KRS Global Biotechnology Recalls Ophthalmic Solution Due to Labeling Errors
KRS Global Biotechnology is recalling 297 droptainers of a multi-ingredient ophthalmic solution because the Beyond Use Date exceeds the expiration date of at least one ingredient.
Product
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0163-2018·2018-01-17
KRS Global Biotechnology Recalls Anastrozole SR Capsules Due to Labeling Errors
KRS Global Biotechnology is recalling Anastrozole SR 1 mg capsules because the Beyond Use Dates exceed the expiration dates of some ingredients.
Product
Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0169-2018·2018-01-17
KRS Global Biotechnology Recalls Chloramphenicol Otic Capsules Due to Labeling Errors
KRS Global Biotechnology is recalling Chloramphenicol 50 mg/Sulfamethoxazole 50 mg/Amphotericin-B 5 mg capsules because the Beyond Use Date exceeds the expiration date of at least one ingredient.
Product
Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0175-2018·2018-01-17
KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Labeling Errors
KRS Global Biotechnology is recalling 6,414 vials of Human Chorionic Gonadotropin because the Beyond Use Date exceeds the expiration date of at least one ingredient.
Product
Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0207-2018·2018-01-17
KRS Global Biotechnology Recalls 7-Keto DHEA Capsules Due to Labeling Error
KRS Global Biotechnology is recalling 7-Keto DHEA 25mg capsules because the Beyond Use Date exceeds the expiration date of at least one ingredient.
Product
7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0189-2018·2018-01-17
KRS Global Biotechnology Recalls QUADMIX #16 Due to Labeling Errors
KRS Global Biotechnology is recalling 126 vials of QUADMIX #16 because the Beyond Use Date exceeds the expiration date of at least one ingredient.
Product
QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0192-2018·2018-01-17
FDA Recalls Savinase Topical Solution Due to Expired Ingredient Labeling
KRS Global Biotechnology is recalling Savinase 100 mcg/mL Topical Solution because the product's beyond-use date exceeds the expiration date of at least one ingredient.
Product
Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0211-2018·2018-01-17
Akorn Recalls Gabapentin Oral Solution Due to Unapproved Manufacturer
Akorn Inc is recalling 4,885 bottles of Gabapentin Oral Solution because the product was released with an unapproved active ingredient manufacturer.
Product
Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0153-2018·2018-01-17
Enoxaparin Sodium Injection Recalled for Labeling Error on Declared Strength
Sanofi-Aventis is recalling Enoxaparin Sodium injections because a single syringe with a different strength was found in a carton labeled 120 mg/0.8 mL.
Product
ENOXAPARIN SODIUM — ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0152-2018·2018-01-10
Fresenius Kabi Recalls Mislabelled Midazolam Syringes Containing Ondansetron
Fresenius Kabi is recalling 203,136 syringes of Midazolam Injection that were mislabeled and actually contain Ondansetron Injection.
Product
MIDAZOLAM — MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0149-2018·2018-01-10
FDA Recalls Unapproved Enhanced Vegetal Vigra Capsules Tainted with Sildenafil
Natures Supplement is recalling Enhanced Vegetal Vigra 200 mg capsules because FDA analysis found the product was tainted with Sildenafil and marketed without an approved NDA/ANDA.
Product
Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-shaking (Int'l) Cop. USA, ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA --- UPC# 8931028556885
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0151-2018·2018-01-10
Pfizer Recalls Zoloft Tablets Due to Weight Variations
Pfizer is recalling 1,972 bottles of Zoloft 25 mg tablets because weight variations caused some tablets to be sub or super potent.
Product
Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
Category
Drug
Distribution
Distributed nationwide

How to read this listing

Filters

10226–10250 of 17987