Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

4551–4575 of 4878

SevereFDA (Drugs)·D-0845-2021·2021-10-06
Neutrogena Beach Defense Sunscreen Spray Recalled for Benzene Contamination
Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 60+) in 8.5 oz aerosol cans due to the presence of benzene contamination.
Product
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1017-2021·2021-10-06
Velvet Ice Cream Raspberry Fudge Cordial Recalled for Undeclared Allergen
Velvet Ice Cream Company is voluntarily recalling Velvet Ice Cream Raspberry Fudge Cordial because it contains an undeclared allergen that is not listed on the label.
Product
Velvet Ice Cream Raspberry Fudge Cordial 1.75 quarts (56oz) 6 quarts per case
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-2583-2021·2021-10-06
Ultrasound Gels and Lotions Recalled Due to Bacterial Contamination Risk
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA issued a Class I recall on August 18, 2021.
Product
EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0896-2021·2021-10-06
ceFAZolin Injectable Recalled for Lack of Sterility Assurance
IntegraDose Compounding Services LLC is recalling ceFAZolin 2 G/20 mL sterile syringes for injection due to lack of sterility assurance. Approximately 2,614 syringes distributed in NH, MA, and MN are affected.
Product
ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1
Category
Drug
Distribution
3 states
SevereFDA (Devices)·Z-2518-2021·2021-10-06
FDA Recalls Ultrasound Gels for Bacterial Contamination Risk
Omnisound Gel and EcoGel 200 ultrasound gels distributed nationwide from January 2018 to August 2021 may contain bacterial contamination. The FDA issued a Class I recall; health care providers should immediately stop using these products.
Product
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0844-2021·2021-10-06
Neutrogena Beach Defense Sunscreen Spray Recalled for Benzene Contamination
Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 50) due to the presence of benzene contamination. The recall affects 1,437,804 aerosol cans distributed nationwide.
Product
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0899-2021·2021-10-06
Testosterone Cypionate/Propionate Injection Recalled for Sterility Assurance
New Vitalis Pharmacy is recalling Testosterone Cypionate and Testosterone Propionate injections nationwide due to lack of assurance of sterility. The recall affects 1,347 vials distributed across multiple lots.
Product
Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·21V328000·2021-10-05
2021 Peterbilt Brake Chamber Defect May Increase Crash Risk
PACCAR is recalling certain 2021 Peterbilt 348 and 579 vehicles due to brake chamber defects. Incorrectly assembled springs may cause pressure loss and increase crash risk.
Product
PETERBILT — 2021 PETERBILT 348
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V062000·2021-10-02
Certain 2019–2021 BMW Models Recalled for Brake System Defect
BMW is recalling certain 2019–2021 models due to improper welding of the integrated brake system rotor and shaft, which could separate during hard braking and cause loss of braking assistance. Owners should contact BMW customer service at 1-800-525-7417 for a free replacement.
Product
BMW — 2020 BMW 840I
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-1006-2021·2021-09-29
Golden Natural Product Dried Apricots Recalled for Undeclared Sulfites
Golden Natural Product Inc. brand Dried Apricot Subkhon products (with bone and jumbo varieties) are being recalled because they contain high levels of undeclared sulfites. The affected products have lot number GC005 and expiration date 2023.
Product
Golden Natural Product Inc. brand Dried Apricot Subkhon with Bone, Net Wt. 16 oz (1 lb) 454 g; and Golden Natural Product Inc. brand Dried Apricot Subkhon Jumbo, Net Wt. 16 oz (1 lb) 454 g Manufactured and Packed by: Gardencells LLC, Urgut, Samarkand region Republic of Uzbekist
Category
Food
Distribution
3 states
SevereFDA (Devices)·Z-2469-2021·2021-09-29
Multiple Ultrasound Gel Products Recalled for Potential Bacterial Contamination
Ultrasound gels sold under multiple brand names have been recalled due to potential bacterial contamination. Approximately 100,114 units distributed nationwide between August 2018 and August 2021 are affected.
Product
Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasoun
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2480-2021·2021-09-29
Ultrasound Gels and Lotions Recalled Due to Bacterial Contamination
Eco-Med Pharmaceutical, Inc. is recalling ultrasound gels and lotions that may contain bacterial contamination. Products were distributed nationally and internationally.
Product
EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0827-2021·2021-09-29
Arformoterol Tartrate Inhalation Solution Recall Due to Sterility Assurance
Glenmark Pharmaceuticals is recalling Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL nationwide because the manufacturer lacks assurance of sterility for affected lots.
Product
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65;
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1008-2021·2021-09-29
Kroger Kale Bags Recalled for Potential Listeria Contamination
The Kroger Co. is recalling Kroger Kale Bags (16 oz) due to potential contamination with Listeria Monocytogenes. The affected product was distributed to retail locations in seven states.
Product
Kroger Kale Bag 16oz plastic bag 8 packages per case
Category
Food
Distribution
7 states
SevereFDA (Drugs)·D-0820-2021·2021-09-29
Fulvestrant Injection Recall: Lack of Sterility Assurance
Glenmark Pharmaceuticals is recalling Fulvestrant Injection 250 mg/5 mL due to lack of assurance of sterility. The affected product was distributed nationwide in 28,658 cartons across multiple lots.
Product
FULVESTRANT — FULVESTRANT (FULVESTRANT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0830-2021·2021-09-29
Avicel RC-591 NF Bulk Powder Recalled for Microbial Contamination
DuPont Nutrition USA is recalling Avicel RC-591 NF bulk powder (lot #2173766940) due to out-of-specification microbial contamination. The product was distributed as a component in finished drug formulations nationwide.
Product
Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0988-2021·2021-09-29
Joy Coriander Chutney Recalled for Undeclared Sulfites
Joy Coriander Chutney (8 oz, best by 07/30/22) is being recalled because it contains high levels of undeclared sulfites. Consumers with sulfite sensitivity should not consume this product.
Product
2. "***JOY***Coriander Chutney***NET WT 8 OZ (228g)***07 28 BEST BY 073022***INGREDIENTS: CORIANDER, GREEN CHILLIES, COCONUT, SUGAR, SALT, SPICES, VINEGAR, STABILIZERS (GUAR, TRAGAGANTH AND XANTHAN), CITIRC ACID, SODIUM BENZOATE AS PRESERVATIVE & ARTIFICIAL COLORS (FD&C BLUE 1 &
Category
Food
Distribution
3 states
SevereFDA (Food)·F-1009-2021·2021-09-29
Banquet Cut European Style Cold Smoked Salmon Recalled for Botulinum Risk
Seabear Company is recalling Banquet Cut European Style Cold Smoked Salmon due to potential for growth of Clostridium botulinum. The affected product was distributed in Arizona, California, and Georgia.
Product
Banquet Cut European Style Cold Smoked Salmon, Item Number 2-92845, brand Gerard and Dominique Seafoods, packaged in pouch, net wt. per pouch is random, frozen, UPC of pouch: 2 92845 00250 3. The storage/thawing instructions on the pouch is read in parts: "***KEEP FROZEN UNTIL
Category
Food
Distribution
3 states
SevereFDA (Drugs)·D-0819-2021·2021-09-29
X Rated Honey For Men Recalled for Undisclosed Tadalafil
Phe Inc is recalling X Rated Honey For Men packets nationwide because the product contains Tadalafil and was marketed without FDA approval. Consumers should stop use immediately.
Product
X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2429-2021·2021-09-22
Cordis Angiographic Catheter Recall Due to Potential Marker Band Dislodgement
Cordis is recalling approximately 1,610 SUPER TORQUE PIG PIGTAIL SPECIAL angiographic catheters worldwide because the device can become entrapped between endovascular devices and the vessel wall, potentially causing marker band movement or dislodgement.
Product
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0800-2021·2021-09-22
Lidocaine Hydrochloride Topical Solution Recalled for Superpotency
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution, USP 4% due to the product being superpotent. The recall affects 32,544 bottles distributed nationwide in the United States and Canada.
Product
Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0803-2021·2021-09-22
MIC+Methyl B12 Injection Recalled for Lack of Processing Controls
Promise Pharmacy is recalling MIC+Methyl B12 injection (57 vials, Lot# 06152021@2) distributed across five states due to lack of processing controls that may affect product quality and safety.
Product
MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS
Category
Drug
Distribution
5 states
SevereFDA (Devices)·Z-2430-2021·2021-09-22
Cordis SUPER TORQUE Angiographic Catheter Recalled for Entrapment Risk
Cordis is recalling the SUPER TORQUE MB angiographic catheter (18,730 units) due to risk of entrapment between endovascular devices and vessel wall, which can cause marker band movement or dislodgement. Units were distributed worldwide.
Product
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0797-2021·2021-09-22
Hydro Pineapple Burn Max Health Supplement Recalled for Undeclared Sibutramine
Hydro Pineapple Burn Max Health supplement sachets are being recalled because they contain undeclared sibutramine and were marketed without FDA approval. The product was distributed nationwide.
Product
Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1005-2021·2021-09-22
Loki Fish Wild Keta Salmon Lox Recalled for Listeria Contamination
Loki Fish Company is recalling Loki Fish Wild Keta Salmon Lox (4 oz. pouches, UPC 92103 00111) distributed in Oregon and Washington due to potential Listeria monocytogenes contamination.
Product
Loki Fish Wild Keta Salmon Lox, packaged in a 4 oz. plastic pouch, sliced on a coated board, 24 packages to a case. UPC 92103 00111. The label is read in parts: LOKI FISH *** WILD KETA LOX *** Ingredients: Wild Keta salmon, honey, salt and spices *** PRODUCT OF USA *** KEEP RE
Category
Food
Distribution
0 states