Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

301–325 of 21557

ModerateFDA (Devices)·Z-2332-2026·2026-06-17
SporeTraq 12-test mail-in spore testing service used incorrect incubation
The SporeTraq Mail-In Spore Testing Service, 12 tests, is being recalled because an incorrect incubation process was performed on the product.
Product
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strip
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0587-2026·2026-06-17
Niacin extended-release tablets failed dissolution testing at 24 hours
GSMS Niacin Extended-Release Tablets, USP, 1,000 mg, are being recalled after a lot was out of specification for stage 3 dissolution at the 24-hour timepoint. 2,961 bottles affected.
Product
NIACIN — NIACIN (NIACIN)
Category
Drug
Distribution
0 states
ModerateFDA (Food)·H-0930-2026·2026-06-17
Marquesita strawberry flavored cakes contain undeclared synthetic color additives
Marquesita de Fresa flavored cakes, 16 oz, are being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 629 units are affected.
Product
Marquesita de Fresa [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Category
Food
Distribution
2 states
ModerateFDA (Food)·H-0925-2026·2026-06-17
Guava cake 47 ounce containers hold undeclared synthetic color additives
Cake de Guayaba, 47 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 311 units are affected.
Product
Cake de Guayaba [image] Guava Cake The Original, Net Wt. 47 oz, packaged in a plastic container, one unit per container. KEEP REFRIGERATED. UPC 824790852782
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-2354-2026·2026-06-17
Philips DigitalDiagnost C90 delivered without required wall stand seismic kit
A DigitalDiagnost C90 radiography system is being recalled because it was delivered without the seismic kit required for the Wall Stand VS2. One unit is affected.
Product
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Category
Medical Device
Distribution
1 state
ModerateFDA (Food)·H-0931-2026·2026-06-17
Marquesita dulce de leche cakes contain undeclared synthetic color additives
Marquesita de Dulceleche flavored cakes, 16 oz, are being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 877 units are affected.
Product
Marquesita de Dulceleche [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-2331-2026·2026-06-17
SporeTraq 52-test mail-in spore testing service used incorrect incubation
The SporeTraq Mail-In Spore Testing Service, 52 tests, is being recalled because an incorrect incubation process was performed on the product. 2,210 units are affected.
Product
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strip
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0597-2026·2026-06-17
Minocycline extended-release tablets failed dissolution testing during stability analysis
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, are being recalled after an out-of-specification dissolution result at the ninth month of testing. 360 bottles affected.
Product
MINOCYCLINE HYDROCHLORIDE — MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0581-2026·2026-06-17
Fresenius Kabi epinephrine injection vials failed impurities and degradation specifications
Epinephrine Injection, USP, 1 mg/mL single-dose vials from Fresenius Kabi are being recalled because they failed impurities and degradation specifications. 898,050 vials affected.
Product
EPINEPHRINE — EPINEPHRINE (EPINEPHRINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·H-1109-2026·2026-06-17
Neuro Nourish dietary supplement recalled over premature lipid oxidation
Neuro Nourish, a 6-in-1 nutritional supplement, is being recalled because premature lipid oxidation may give the product an off odor and bitter taste. 512 units affected.
Product
NEURO NOURISH dietary supplement; 6-IN-1 PREBIOTIC, PROBIOTIC, VITAMIN, MINERAL, FATTY ACID, AND ANTIOXIDANT NUTRITIONAL SUPPLEMENT TO SUPPORT DRAIN AND GUT HEALTH NET WT. 5.9 OZ; UPC: 310M5951601
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0923-2026·2026-06-17
Coconut cake 47 ounce containers hold undeclared synthetic color additives
Cake de Coco, 47 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 241 units are affected.
Product
Cake de Coco [image] Coconut Cake The Original, Net Wt. 47 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790852775
Category
Food
Distribution
2 states
ModerateFDA (Food)·H-0937-2026·2026-06-17
Flan custard cake recalled for undeclared Yellow and Red dyes
Flan Cake (Custard Cake), 30 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 423 units are affected.
Product
Flan Cake [image] Custard Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852959
Category
Food
Distribution
2 states
ModerateFDA (Food)·H-0928-2026·2026-06-17
Marquesita guava cakes contain undeclared synthetic color additives
Marquesita de Guava flavored cakes, 16 oz, are being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 1,316 units are affected.
Product
Marquesita de Guava [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-2355-2026·2026-06-17
NeoSpan compression staple kits missing Magnetic Resonance Conditional labeling symbol
NeoSpan SuperElastic Compression Staple kits are being recalled because the Magnetic Resonance Conditional symbol is missing from the carton, inner tray and patient label. 306 kits affected.
Product
NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 12x12x1
Category
Medical Device
Distribution
25 states
ModerateFDA (Food)·H-0934-2026·2026-06-17
Mango cheesecake 26 ounce containers hold undeclared synthetic color additives
Cheesecake de Mango, 26 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 93 units are affected.
Product
Cheesecake de Mango [image] Mango Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852836
Category
Food
Distribution
2 states
ModerateFDA (Food)·H-0924-2026·2026-06-17
Strawberry and chocolate cakes contain undeclared synthetic color additives
Cake de Fresa y Chocolate, 48 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 190 units are affected.
Product
Cake de Fresa y Chocolate [image] Stawberry & Chocolate Cake The Original, Net Wt. 48 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790852980
Category
Food
Distribution
2 states
ModerateFDA (Food)·H-0933-2026·2026-06-17
Caramel cheesecake recalled for undeclared Yellow and Red color additives
Cheesecake de Dulce de Leche, 26 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 498 units are affected.
Product
Cheesecake de Dulce de Leche [image] Caramel Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852829
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-2320-2026·2026-06-17
EXCOR pediatric blood pump valves carry mismatched inner package expiration dates
EXCOR Pediatric VAD System blood pump PU valves are being recalled because the inner package expiration date does not match the correct outer package date.
Product
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0913-2026·2026-06-17
Estrella passion fruit drink does not declare FD&C Red 40
Estrella Bebida de Parcha (Passion Fruit Drink) in three sizes is being recalled because of undeclared FD&C Red 40. A total of 2,111 units are affected.
Product
ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of 25 bottles. KEEP REFRIGIRATED.
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-2403-2026·2026-06-17
Boston Scientific reusable TCN nitinol electrodes may underperform expected levels
Boston Scientific TCN nitinol electrodes across four lengths are being recalled because the reusable electrodes may not meet expected performance levels. 49,251 units affected.
Product
Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0936-2026·2026-06-17
Guava cheesecake 26 ounce containers hold undeclared synthetic color additives
Cheesecake de Guava, 26 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 375 units are affected.
Product
Cheesecake de Guava [image] Guava Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790853116
Category
Food
Distribution
2 states
ModerateFDA (Food)·H-0938-2026·2026-06-17
Pasteurized donor human milk bottles show dark spot contamination
MMB of Louisiana Pasteurized Donor Human Milk, 3 oz, is being recalled over potential physical contamination after a dark spot was noticed on the bottom of a container. 32 bottles affected.
Product
MMB of Louisiana Pasteurized Donor Human Milk, Volume: 3 oz, Cal/Oz: 19, 0.9 g/dL Protein, packaged in a clear plastic bottle with white plastic cap
Category
Food
Distribution
1 state
ModerateFDA (Food)·H-0916-2026·2026-06-17
Jumbo caramel roll 40 ounce packages contain undeclared color additives
Jumbo Brazo Gitano Caramelo (Jumbo Caramel Roll), 40 oz, is being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 1,116 units are affected.
Product
Jumbo Brazo Gitano Caramelo [image] Jumbo Caramel Roll The Original, Net Wt. 40 oz, packaged in a rigid plastic clamshell container with a transparent dome lid, one unit per container. KEEP REFRIGERATED. UPC 824790852645
Category
Food
Distribution
2 states
ModerateFDA (Food)·H-0920-2026·2026-06-17
Caramel rolls sold in Florida and Texas contain undeclared dyes
Rollitos de DulceLeche (Caramel Rolls), 15 oz, are being recalled because of undeclared colors: Yellow #5, Yellow #6 and/or Red #40. 1,334 units are affected.
Product
Rollitos de DulceLeche [image] Caramel Rolls The Original, Net Wt. 15 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852454
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-2319-2026·2026-06-17
Mahurkar Elite PASS trays shipped without the labeled Tegaderm CHG dressing
Mahurkar Elite PASS Trays are being recalled because the Tegaderm CHG dressing specified in the product labeling was missing from certain lots. 25,627 units are affected.
Product
Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter wi
Category
Medical Device
Distribution
Distributed nationwide