Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

3851–3875 of 52939

HighFDA (Drugs)·D-0553-2025·2025-08-13
Compounded semaglutide 0.22 mg vials recalled over lack of processing controls
Semaglutide + Cyanocobalamin 0.22 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 290 vials are affected.
Product
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-2276-2025·2025-08-13
Guedel airways may carry small burrs that could detach and be inhaled
One-piece Guedel airways, size 3, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 8,640 pieces are affected.
Product
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Category
Medical Device
Distribution
10 states
HighFDA (Drugs)·D-0566-2025·2025-08-13
Doxepin hydrochloride capsules exceed the interim nitrosamine impurity limit
Doxepin Hydrochloride Capsules USP 10 mg from Alembic are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 9,492 bottles affected.
Product
DOXEPIN HYDROCHLORIDE — DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2277-2025·2025-08-13
Stryker SmartPump tourniquet cuff flanges may detach from the bladder
Stryker SmartPump Tourniquet disposable cuffs are being recalled because the cuff flange may become detached from the bladder, which the manufacturer links to a risk of hemorrhage if a leak occurs during a procedure.
Product
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0385-2025·2025-08-13
Favorite Day frosted sugar cookies may contain wood foreign material
Favorite Day Bakery Frosted Sugar Cookies, 10 count, are being recalled because of foreign material, specifically wood. 803 cases are affected.
Product
Favorite Day Bakery Frosted Sugar Cookies, 10 count, Net Wt 13.5 oz (383g). UPC - 85239-41250 3. Dist. By Target Corporation, Minneapolis, MN 55403. Product of Canada.
Category
Food
Distribution
21 states
HighFDA (Drugs)·D-0555-2025·2025-08-13
Compounded tirzepatide 4.4 mg vials recalled over lack of processing controls
Tirzepatide + Niacinamide 4.4 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 170 vials are affected.
Product
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0558-2025·2025-08-13
Compounded tirzepatide 11.24 mg vials recalled over lack of processing controls
Tirzepatide + Niacinamide 11.24 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 146 vials are affected.
Product
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Food)·H-0382-2025·2025-08-13
Queen Bee Gardens raspberry whipped honey may contain stainless steel flakes
Queen Bee Gardens Whipped Honey Raspberry in 11 oz jars is being recalled because the product may have small flakes of stainless steel in it. 129 jars are affected.
Product
Brand Name: Queen Bee Gardens Whipped Honey Raspberry. Intended use: spread. Item is shelf stable. Packaging type: Jar. Net wt., 11oz. UPC: 788394182358. Firm Name: Queen Bee Gardens Firm Address: 262 East Main Street, Lovell, WY 82431
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0563-2025·2025-08-13
Compounded semaglutide 1.5 mg vials recalled over lack of processing controls
Semaglutide + Cyanocobalamin 1.5 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 190 vials are affected.
Product
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Food)·H-0389-2025·2025-08-13
Breaded jalapeno mac and cheese bites used a recalled Listeria ingredient
Breaded Jalapeno Mac & Cheese Bites in 30 lb cases are being recalled because a supplier recalled an ingredient used in the finished product for possible Listeria monocytogenes contamination. 819 cases affected.
Product
BREADED JALAPENO MAC & CHEESE BITES Mac & Cheese Bites, Net Wt. 30 LB. 90935, (01)10077886909359, Prepared and Packaged by LOUISA FOOD PRODUCTS, INC. St. Louis, MO 63136; COOKING DIRECTIONS: Deep fry at 350F for 3 1/2 to 4 minutes or until internal temperature reaches 160F.
Category
Food
Distribution
2 states
HighFDA (Food)·H-0456-2025·2025-08-13
Frederik's by Meijer sea salt flatbread crackers contain undeclared sesame
Frederik's by Meijer Artisan Baked Sea Salt flatbread crackers, 5.5 oz, are being recalled because of undeclared sesame. 1,790 retail units are affected.
Product
Frederik's by Meijer Artisan Baked Sea Salt flatbread crackers net wt 5.5oz. UPC 7 13733 00048 2
Category
Food
Distribution
3 states
HighFDA (Drugs)·D-0554-2025·2025-08-13
Compounded tirzepatide and niacinamide vials recalled over lack of processing controls
Tirzepatide + Niacinamide 2.2 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 236 vials are affected.
Product
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-2264-2025·2025-08-13
UIBC assay does not meet its labeled hemoglobin interference claim
The Unsaturated Iron Binding Capacity assay is being recalled because it is not meeting the labeled hemoglobin interference claims stated in its instructions for use. 56,696 units affected.
Product
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Category
Medical Device
Distribution
9 states
HighFDA (Drugs)·D-0574-2025·2025-08-13
Spironolactone 25 mg tablets recalled after aluminum was found in product
Spironolactone Tablets USP 25 mg are being recalled because of the presence of a foreign substance identified as aluminum. 11,328 bottles are affected.
Product
SPIRONOLACTONE — SPIRONOLACTONE (SPIRONOLACTONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0562-2025·2025-08-13
Compounded semaglutide and cyanocobalamin vials recalled over lack of processing controls
Semaglutide + Cyanocobalamin 0.88 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 194 vials are affected.
Product
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0561-2025·2025-08-13
Compounded semaglutide 0.44 mg vials recalled over lack of processing controls
Semaglutide + Cyanocobalamin 0.44 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 221 vials are affected.
Product
Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-2275-2025·2025-08-13
Size 2 Guedel airways may carry small burrs that could detach
One-piece Guedel airways, size 2, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 2,800 pieces are affected.
Product
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2274-2025·2025-08-13
DASH COVID and flu tests may give a false negative result
DASH SARS-CoV-2 & Flu A/B Tests are being recalled because a manufacturing error means the assay may result in a missed diagnosis or delay of treatment through a potential false negative. 710 units affected.
Product
DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.
Category
Medical Device
Distribution
4 states
HighFDA (Food)·H-0392-2025·2025-08-13
Cesarina Mediterranean mix cookies omit sesame from the contains statement
Cesarina Mediterranean Mix Cookies, 16 oz, are being recalled because sesame is not listed in the Contains statement. 30 cases are affected.
Product
MEDITERRANEAN MIX COOKIES, Cesarina Cookies, Net Weight. 16 oz. (454g), packaged in plastic clam shell containers, 12 packages per master case. Dry storage.
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2239-2025·2025-08-13
Pinnacle 3 radiation planning software may miscalculate stopping power ratio
Pinnacle 3 with TumorLOC Radiation Therapy Planning System software is being recalled because a software issue may provide incorrect dataset calculations when performing the Stopping Power Ratio. 149 serial numbers affected.
Product
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0556-2025·2025-08-13
Compounded tirzepatide 6.6 mg vials recalled over lack of processing controls
Tirzepatide + Niacinamide 6.6 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 160 vials are affected.
Product
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0557-2025·2025-08-13
Compounded tirzepatide 8.8 mg vials recalled over lack of processing controls
Tirzepatide + Niacinamide 8.8 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 139 vials are affected.
Product
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-2272-2025·2025-08-13
epoc BUN test cards may show a negative sodium bias
epoc BGEM BUN Test Cards are being recalled because a negative sodium bias may exist in some lots, with an observed average bias of -4.4 mmol/L. 37,554 units are affected.
Product
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0560-2025·2025-08-13
Compounded tirzepatide 16.6 mg vials recalled over lack of processing controls
Tirzepatide + Niacinamide 16.6 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 155 vials are affected.
Product
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0552-2025·2025-08-13
Duloxetine 60 mg capsules exceed the safety assessment limit for nitrosamine
Duloxetine Delayed-Release Capsules USP 60 mg distributed by Breckenridge are being recalled because N-nitroso-duloxetine was present above the safety assessment limit. 1,829 bottles affected.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide