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

5451–5475 of 17974

SevereFDA (Drugs)·D-0345-2021·2021-05-05
CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Contamination
CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth breached package integrity under labeled storage conditions.
Product
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 26040
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0353-2021·2021-05-05
FDA Recalls PremierZen Platinum 5000 for Unapproved Active Ingredients
Na Na Collection is recalling PremierZen Platinum 5000 capsules because FDA analysis detected unapproved active ingredients tadalafil and/or sildenafil.
Product
PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0347-2021·2021-05-05
ChloraPrep One-Step Recalled for Potential Fungal Growth and Sterility Breach
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to potential fungal growth that may breach package integrity and compromise sterility.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0350-2021·2021-05-05
CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk
CareFusion 213, LLC is recalling ChloraPrep With Tint antiseptic applicators because fungal growth may breach package integrity at labeled storage conditions.
Product
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0355-2021·2021-05-05
Grace Healthcare Recalls Compressed Oxygen Cylinders Due to Manufacturing Deviations
Grace Healthcare Medical, Inc. is voluntarily recalling 35,838 compressed oxygen cylinders nationwide due to cGMP deviations. The recall was initiated in April 2021.
Product
Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue Gulfpo
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0349-2021·2021-05-05
CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk
CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth may breach package integrity. The product was distributed in the US and 12 other countries.
Product
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 26040
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0357-2021·2021-05-05
Genentech Recalls Evrysdi Oral Solution Due to Defective Bottle Adapters
Genentech is recalling 2,627 bottles of Evrysdi (risdiplam) for oral solution because some have incorrect press-in-bottle-adapters that do not fit co-packed syringes.
Product
Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0339-2021·2021-05-05
Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity Failures
Teligent Pharma is recalling 79,416 tubes of Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) because the product failed impurity specifications.
Product
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0338-2021·2021-05-05
Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity Failure
Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% because it failed impurity specifications for a known degradation product.
Product
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0340-2021·2021-05-05
Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity
Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% due to failed impurity specifications. The product is distributed nationwide in 15-gram tubes.
Product
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0356-2021·2021-04-28
Teligent Pharma Recalls Flurandrenolide Ointment Due to Impurity Failures
Teligent Pharma is recalling 3,432 tubes of Flurandrenolide Ointment 0.05% because the product failed impurity and degradation specifications.
Product
Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0335-2021·2021-04-28
Edge Pharma Recalls Betadine Ophthalmic Syringes Due to Sterility Concerns
Edge Pharma is recalling 5,850 syringes of Betadine ophthalmic solution because a defective container may compromise sterility. The product is distributed nationwide.
Product
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0336-2021·2021-04-28
Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defects
Noven Pharmaceuticals is recalling Minivelle estradiol transdermal patches because the adhesive may not stick well to the skin.
Product
MINIVELLE — MINIVELLE (ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0337-2021·2021-04-28
Noven Recalls Estradiol Transdermal Patches Due to Adhesive Defects
Noven Pharmaceuticals is recalling Estradiol Transdermal Systems because the adhesive may not stick well to the skin.
Product
ESTRADIOL — ESTRADIOL (ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0614-2021·2021-04-21
Novo Nordisk Recalls Levemir Insulin Pens Due to Temperature Abuse
Novo Nordisk is recalling Levemir FlexTouch insulin pens stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.
Product
LEVEMIR — LEVEMIR (INSULIN DETEMIR)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0359-2021·2021-04-21
Spartan Chemical Recalls Lite'n Foamy Hand Sanitizer Due to Microbial Contamination
Spartan Chemical is recalling 19,044 containers of Lite'n Foamy Lemon Blossom Hand Sanitizer because a lot tested positive for Burkholderia multivorans.
Product
Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26288 5 SKU# 333806 NDC:
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0613-2021·2021-04-21
Novo Nordisk Recalls Fiasp Insulin Samples Due to Temperature Abuse
Novo Nordisk is recalling Fiasp (insulin aspart injection) samples stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.
Product
FIASP — FIASP (INSULIN ASPART INJECTION)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0620-2021·2021-04-21
Novo Nordisk Recalls TRESIBA Insulin Samples Due to Temperature Abuse
Novo Nordisk is recalling TRESIBA (insulin degludec) samples stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.
Product
TRESIBA — TRESIBA (INSULIN DEGLUDEC)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0621-2021·2021-04-21
Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse
Novo Nordisk is recalling specific lots of TRESIBA insulin pens because they were stored below 32°F, which may reduce efficacy and damage the device.
Product
TRESIBA — TRESIBA (INSULIN DEGLUDEC)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0611-2021·2021-04-21
Novo Nordisk Recalls Fiasp Insulin Pens Due to Temperature Abuse
Novo Nordisk is recalling Fiasp insulin pen samples stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.
Product
FIASP — FIASP (INSULIN ASPART INJECTION)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0612-2021·2021-04-21
Novo Nordisk Recalls Fiasp Insulin Due to Temperature Abuse
Novo Nordisk is recalling Fiasp insulin cartridges stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.
Product
FIASP — FIASP (INSULIN ASPART INJECTION)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0619-2021·2021-04-21
Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse
Novo Nordisk is recalling TRESIBA (insulin degludec) prefilled pens because they were stored below 32°F, which may reduce efficacy and damage the device.
Product
TRESIBA — TRESIBA (INSULIN DEGLUDEC)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0616-2021·2021-04-21
Novo Nordisk Recalls Insulin Diluting Medium Due to Temperature Abuse
Novo Nordisk Inc is recalling samples of Insulin Diluting Medium for NovoLog because storage below 32°F may cause lack of efficacy and damage to cartridges and pen-injectors.
Product
INSULIN DILUTING MEDIUM FOR NOVOLOG — INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0615-2021·2021-04-21
Novo Nordisk Recalls Insulin Diluting Medium Due to Temperature Abuse
Novo Nordisk is recalling specific samples of Insulin Diluting Medium for NovoLog because they were stored below 32°F, potentially causing lack of efficacy and damage to the cartridge and pen-injectors.
Product
INSULIN DILUTING MEDIUM FOR NOVOLOG — INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0361-2021·2021-04-21
Spartan Chemical Recalls Antiseptic Hand Cleaner Due to Manufacturing Deviations
Spartan Chemical Co Inc is recalling 400 gallons of Antiseptic Hand Cleaner due to CGMP deviations. The product was distributed nationwide in the US, Puerto Rico, and Mexico.
Product
ANTISEPTIC HAND CLEANER — ANTISEPTIC HAND CLEANER (CHLOROXYLENOL)
Category
Drug
Distribution
Distributed nationwide

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5451–5475 of 17974