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.

1601–1625 of 29084

SevereFDA (Food)·H-0068-2025·2025-07-02
Frozen Shrimp Recalled for Undeclared Sulfites
TRI-UNION FROZEN PRODUCTS INC (Chicken of the Sea Frozen Food) is recalling frozen raw peeled and deveined tail-on shrimp because they contain undeclared sulfites, a potential allergen.
Product
Frozen Shrimp- packaged in 5lb frozen IQF blocks/4 blocks to a case. Unlabeled generic case packaging reads: "Raw P&D Tail-On White Shrimp" 26/30; Contains: Shrimp (Crustacean) UPC# 1 08432370 0405 5
Category
Food
Distribution
0 states
SevereFDA (Food)·H-0111-2025·2025-07-02
Hy-Vee Duo Crispy Calif Shrimp recalled for Listeria contamination
Hy-Vee is recalling Duo Crispy Calif Shrimp 10Pc due to potential contamination with Listeria monocytogenes. Affected cases were distributed to retail locations throughout the Midwest.
Product
Duo Crispy Calif Shrimp 10Pc
Category
Food
Distribution
0 states
SevereFDA (Food)·H-0102-2025·2025-07-02
Mediterranean Pasta Salad Recalled for Salmonella Contamination
Isabelle's Kitchen, Inc. is recalling Mediterranean Pasta Salad due to Salmonella contamination. The affected product was distributed in Pennsylvania and Maryland.
Product
Isabelle's Kitchen, Inc, Maple Avenue Foods Mediterranean Pasta Salad , 4.5 lb., High density polyethylene container with sealed lid.
Category
Food
Distribution
2 states
SevereFDA (Food)·H-0067-2025·2025-07-02
Salted Smoked Split Herring Recalled for Botulinum Contamination
P East Trading Corp is recalling Salted Smoked Split Herring due to potential Clostridium botulinum contamination in uneviscerated fish. The product was distributed to retail locations in New York, New Jersey, and Connecticut.
Product
Salted Smoked Split Herring, approximately 12 inches in length; packaged in 18 lb wooden box and repacked at retail in deli-style or other retail packaging (for a list of retail locations see associated press release)
Category
Food
Distribution
3 states
SevereFDA (Food)·H-0103-2025·2025-07-02
Isabelle's Kitchen Crunchy Wheatberry Salad recalled for Salmonella
Isabelle's Kitchen, Inc. is recalling Maple Avenue Foods Crunchy Wheatberry Salad due to Salmonella contamination. The 5 lb. containers were distributed to Pennsylvania and Maryland.
Product
Isabelle's Kitchen, Inc, Maple Avenue Foods Crunchy Wheatberry Salad , 5 lb., High density polyethylene container with sealed lid.
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0476-2025·2025-07-02
LL Bioboost Injectable pre-filled syringes recalled for lack of sterility assurance
Thrive Health and Wellness, LLC is recalling LL Bioboost Injectable pre-filled syringes nationwide due to lack of assurance of sterility. The affected product is Lot #H277639 with expiration 6/25/2025.
Product
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·H-0112-2025·2025-07-02
Duo Crunchy Veg Shrimp 10Pc recalled for Listeria contamination
Hy-Vee is recalling Duo Crunchy Veg Shrimp 10Pc due to potential contamination with Listeria monocytogenes. The affected product was distributed to retail locations throughout the Midwest.
Product
Duo Crunchy Veg Shrimp 10Pc
Category
Food
Distribution
0 states
SevereFDA (Food)·H-0108-2025·2025-07-02
Duo Spicy Calif Shrimp 10Pc recalled for Listeria contamination
Hy-Vee is recalling Duo Spicy Calif Shrimp 10Pc due to potential contamination with Listeria monocytogenes. Affected product was distributed to retail locations throughout the Midwest.
Product
Duo Spicy Calif Shrimp 10Pc
Category
Food
Distribution
0 states
SevereFDA (Food)·H-0109-2025·2025-07-02
Hy-Vee Duo Spicy Veg Shrimp recalled for Listeria monocytogenes contamination
Hy-Vee is recalling Duo Spicy Veg Shrimp 10Pc due to potential contamination with Listeria monocytogenes. Affected product was distributed to retail locations throughout the Midwest.
Product
Duo Spicy Veg Shrimp 10Pc
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0473-2025·2025-07-02
Metoclopramide Tablets Recalled for Presence of Foreign Tablets
Teva Pharmaceuticals USA, Inc. is recalling Metoclopramide Tablets, USP 10 mg due to the presence of foreign tablets or capsules in the product. The affected lot is distributed nationwide.
Product
METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·H-0100-2025·2025-07-02
Maple Avenue Foods Powerhouse Wheatberry Salad Kit Recalled for Salmonella
Isabelle's Kitchen, Inc. is recalling Maple Avenue Foods Powerhouse Wheatberry Salad Kit due to Salmonella contamination. The product was distributed to Pennsylvania and Maryland.
Product
Maple Avenue Foods Powerhouse Wheatberry Salad Kit, 4.5lbs, High density polyethylene container with sealed lid
Category
Food
Distribution
2 states
SevereFDA (Devices)·Z-2016-2025·2025-07-02
Omnipod 5 iOS App software design issue causes insulin overdose risk
Insulet Corporation is recalling the Omnipod 5 iOS App due to a software issue where decimal separators are not recognized in manual insulin entry, potentially causing insulin overdose and severe hypoglycemia.
Product
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface t
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0480-2025·2025-07-02
Semaglutide pre-filled syringe recalled due to sterility concerns
Thrive Health Solutions is recalling Semaglutide 5 mg/mL pre-filled syringes distributed nationwide because the manufacturer cannot assure the product's sterility.
Product
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·H-0114-2025·2025-07-02
Spicy Shrimp Poke Bowl recalled for potential Listeria contamination
Hy-Vee is recalling Spicy Shrimp Poke Bowl products due to potential contamination with Listeria monocytogenes. The product has been distributed to retail locations throughout the Midwest.
Product
Spicy Shrimp Poke Bowl
Category
Food
Distribution
0 states
SevereFDA (Food)·H-0069-2025·2025-07-02
Bornstein Frozen Shrimp Meat Recalled for Listeria Contamination
Bornstein Seafoods Inc. is recalling frozen shrimp meat products after Listeria monocytogenes was detected during the firm's routine testing. The products were distributed nationwide and in Canada.
Product
Bornstein Frozen Shrimp Meat, Wild Caught - Product of USA. Product is cooked and Ready-To-Eat. Processed in the USA by Bornstein Seafoods Inc. Astoria, OR. The following items are being recalled: ZMU41-1003 Fzn Shrimp Meat 250/350 Ct 15 X 1lb. bag (net wt. 15lb) ZMU41-1007 Fzn
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1959-2025·2025-07-02
Extended Tip Applicator 15 CM recalled for endotoxin and sterility issues
Integra LifeSciences is recalling Extended Tip Applicators (15 CM, Box of 5) because they may contain out-of-specification levels of endotoxins and lack sterility assurance.
Product
Extended Tip Applicator, 15 CM, Box of 5.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·H-0105-2025·2025-07-02
Crunchy Shrimp Roll recalled for Listeria monocytogenes risk
Hy-Vee is recalling Crunchy Shrimp Roll due to potential contamination with Listeria monocytogenes. The affected product was distributed to retail locations throughout the Midwest.
Product
Crunchy Shrimp Roll
Category
Food
Distribution
0 states
SevereFDA (Food)·H-0066-2025·2025-07-02
MIGHTYLICIOUS Vegan Oatmeal Coconut Cookies recalled for undeclared milk
Mightylicious Inc. is recalling MIGHTYLICIOUS Vegan Oatmeal Coconut Cookies because they contain undeclared milk, a common allergen not listed on the label. The product was distributed to Rhode Island, Illinois, and New York.
Product
MIGHTYLICIOUS Vegan Oatmeal Coconut Cookies Gluten-Free, Dairy-Free, Allergen Friendly, Egg-Free, Non-GMO, Kosher, Preservative-Free Snack Option for a Guilt-Free Treat - 6.5 Oz, Stand-up pouch, 6 bags per case . UPC: -0085000955838
Category
Food
Distribution
3 states
SevereFDA (Food)·H-0113-2025·2025-07-02
Hy-Vee Duo Crispy Veg Shrimp 10Pc recalled for Listeria monocytogenes
Hy-Vee is recalling Duo Crispy Veg Shrimp 10Pc products due to potential contamination with Listeria monocytogenes. The affected products were distributed to retail locations throughout the Midwest.
Product
Duo Crispy Veg Shrimp 10Pc
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0484-2025·2025-07-02
Tirzepatide Injections recalled due to lack of sterility assurance
Thrive Health Solutions is recalling Tirzepatide Injections 30mg/mL pre-filled syringes due to lack of assurance of sterility. The affected product was distributed nationwide.
Product
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0494-2025·2025-07-02
Ketorolac Tromethamine Ophthalmic Solution Recalled for Sterility Risk
Apotex Corp. is recalling Ketorolac Tromethamine Ophthalmic Solution 0.5% due to lack of assurance of sterility. The recall affects 87,840 bottles distributed nationwide.
Product
KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0481-2025·2025-07-02
Semaglutide/Cyanocobalamin Injectable Syringes Recalled for Lack of Sterility Assurance
Thrive Health Solutions is recalling Semaglutide/Cyanocobalamin Injectable pre-filled syringes due to lack of assurance of sterility. The affected lot was distributed nationwide.
Product
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0486-2025·2025-07-02
Tirzepatide/Cyanocobalamin Injectable Recalled Due to Sterility Assurance Failure
Thrive Health Solutions is recalling one lot of Tirzepatide/Cyanocobalamin Injectable pre-filled syringes due to lack of assurance of sterility. The affected product is Lot C03125A distributed nationwide.
Product
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0531-2025·2025-07-02
Testosterone Cypionate Injection Recalled Without Approved Application
Advanced Pharmaceutical Technology, Inc. is recalling TESTO-200 (Testosterone Cypionate Injection USP, 200mg/ml) because it was marketed without an approved NDA or ANDA.
Product
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01
Category
Drug
Distribution
2 states
SevereFDA (Devices)·Z-1961-2025·2025-07-02
MicroMyst Applicator recalled due to lack of sterility assurance
Integra LifeSciences Corp. is recalling the MicroMyst Applicator Box of 5 due to lack of sterility assurance. The product is used with the Integra Flow Source for controlled application of two liquids.
Product
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
Category
Medical Device
Distribution
Distributed nationwide