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.

18701–18725 of 50407

HighFDA (Drugs)·D-0210-2022·2021-11-17
TRI-MIX PAPAVERINE Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 5 Injectable due to lack of assurance of sterility. The recalled product was distributed in the United States including Washington, D.C. and Puerto Rico.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0122-2022·2021-11-17
L-Carnitine Injectable Injection Recalled for Sterility Concerns
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling L-Carnitine 250mg/mL injectable due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.
Product
L-CARNITINE 250MG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0212-2022·2021-11-17
TRI-MIX Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX Papaverine 30/Phentolamine 2/PGE-1 30 injectable due to lack of assurance of sterility. The product was distributed in the United States, including Washington, D.C. and Puerto Rico.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0168-2022·2021-11-17
Testosterone Bi-Blend Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Bi-Blend 100/100 mg/mL injectable due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.
Product
TESTOSTERONE BI-BLEND 100/100MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Food)·F-0147-2022·2021-11-17
Country Oven Red Velvet Cake Recalled for Possible Metal Fragments
The Kroger Co. is recalling Country Oven Red Velvet Cake in multiple sizes due to possible metal fragments in starch used to manufacture the cakes. The product was distributed across 28 states.
Product
Country Oven Red Velvet Cake 13oz, 28oz, single slices, Double Layer Cake (51 oz), 8oz
Category
Food
Distribution
29 states
HighFDA (Drugs)·D-0220-2022·2021-11-17
Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 4/PGE-1 20 injectable due to lack of assurance of sterility. The recall affects 13 vials distributed across the United States, Washington, D.C., and Puerto Rico.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Food)·F-0143-2022·2021-11-17
Country Oven Bowtie Danish Recalled for Possible Metal Fragments
The Kroger Co is recalling Country Oven Bowtie Danish 3oz packages due to possible metal fragments in starch used to manufacture the cakes. The product was distributed across 28 states.
Product
Country Oven Bowtie Danish 3oz
Category
Food
Distribution
29 states
HighFDA (Drugs)·D-0166-2022·2021-11-17
Injectable testosterone and dutasteride product recall for sterility assurance failure
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Test Cypionate 200mg/Dutasteride 1mg/ml Injectable due to lack of assurance of sterility. Affected lots include T1008312021:02 and T1007142021:62.
Product
TEST CYPIONATE 200MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Food)·F-0128-2022·2021-11-17
E-Z Spuds Inc. Collard Green Crosscut Recalled for Salmonella Risk
E-Z Spuds Inc. is recalling 28 cases of 15-pound Collard Green Crosscut 1/4" products manufactured between September 1 and September 8, 2021, due to potential Salmonella contamination. The affected products were distributed to manufacturers and food service establishments in the Chicago, Illinois metro area.
Product
E-Z Spuds Inc. 15# Collard Green Crosscut 1/4"
Category
Food
Distribution
1 state
HighFDA (Food)·F-0149-2022·2021-11-17
Country Oven Chocolate Cake Single Slices Recalled for Possible Metal Fragments
The Kroger Co is recalling Country Oven Chocolate/Fudge Cake Single Slices due to possible metal fragments in starch used during manufacturing. The affected product was distributed across multiple states.
Product
Country Oven Chocolate/Fudge Cake Single Slices, Double Layer Cake (50oz)
Category
Food
Distribution
29 states
HighFDA (Devices)·Z-0205-2022·2021-11-17
McKesson Safety Blood Collection Needles Recalled Over Safety Mechanism Activation Risk
Nationwide recall of McKesson PREVENT HT Safety Blood Collection Needles (22G 1 1/4 inch) due to potential difficulty activating the safety mechanism. The protective feature may fail to engage properly during use.
Product
McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0136-2022·2021-11-17
Country Oven Cinnamon Rolls recalled for possible metal fragments
The Kroger Co is recalling Country Oven Cinnamon Roll products due to possible metal fragments in the starch used during manufacturing. Affected products were distributed across multiple states.
Product
Country Oven Cinnamon Roll 4oz, 2.5oz
Category
Food
Distribution
29 states
HighFDA (Drugs)·D-0116-2022·2021-11-17
Talon Compounding Pharmacy Injectable Amino Acid Solution Recall
Talon Compounding Pharmacy is recalling GOAL-GLUTAMINE injectable solution due to lack of assurance of sterility. The affected product was distributed across the United States.
Product
GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG+LIDOCAINE 10MG/ML 75MG/75MG/150MG/150MG/10MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Food)·F-0137-2022·2021-11-17
Country Oven White Cake Recalled for Possible Metal Fragments
The Kroger Co is recalling Country Oven White Cake products due to possible metal fragments found in starch used during manufacturing. The recall affects 34 cases distributed across 28 states.
Product
Country Oven White Cake 7lb, 13.5oz, 29oz
Category
Food
Distribution
29 states
HighFDA (Food)·F-0124-2022·2021-11-17
E-Z Spuds Inc. Fresh Cut Green Onions Recalled for Salmonella Risk
E-Z Spuds Inc. is recalling fresh cut green onion products (10 lbs) due to potential Salmonella contamination. The affected product was distributed to manufacturers and food service establishments in the Chicago, IL metro area.
Product
E-Z Spuds Inc. fresh cut green onion products (10 lbs) crosscut
Category
Food
Distribution
1 state
HighFDA (Food)·F-0151-2022·2021-11-17
Country Oven Caramel Apple Double Layer Cake recalled for possible metal fragments
The Kroger Co is recalling Country Oven Caramel Apple Double Layer Cake 32 oz due to possible metal fragments in the starch used to manufacture the cakes.
Product
Country Oven Caramel Apple Double Layer Cake 32 oz
Category
Food
Distribution
29 states
HighFDA (Food)·F-0145-2022·2021-11-17
Country Oven Angel Food Cake recalled for possible metal fragments
The Kroger Co is recalling Country Oven Angel Food Cake 13 oz due to possible metal fragments in the starch used to manufacture the product. The affected product was distributed across 28 states.
Product
Country Oven Angel Food Cake 13 oz
Category
Food
Distribution
29 states
HighFDA (Drugs)·D-0217-2022·2021-11-17
Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 3/PGE-1 30 injectable due to lack of assurance of sterility. The product was distributed across the United States.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0153-2022·2021-11-17
Injectable anabolic steroid compound recalled for lack of sterility assurance
Talon Compounding Pharmacy is recalling an injectable testosterone cypionate compound because the manufacturer cannot assure the product is sterile. The affected vials were distributed across the United States.
Product
TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0196-2022·2021-11-17
Tri-Mix Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of Tri-Mix Papaverine 25MG/Phentolamine 1MG/PGE1 25MCG/ML Injectable due to lack of assurance of sterility.
Product
TRI-MIX PAPAVERINE 25MG/PHENTOLAMINE 1MG/PGE1 25MCG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Food)·F-0150-2022·2021-11-17
Country Oven Yellow/Caramel Cake Recalled for Metal Fragment Risk
The Kroger Co. is recalling Country Oven Yellow/Caramel Cake Single Slices due to possible metal fragments in the starch used during manufacturing. The affected products were distributed across 29 states.
Product
Country Oven Yellow/Caramel Cake Single Slices, double layer cakes ( 48oz )
Category
Food
Distribution
29 states
HighFDA (Food)·F-0127-2022·2021-11-17
E-Z Spuds Inc. Butternut Diced 10# Recalled for Salmonella Contamination
E-Z Spuds Inc. is recalling 10# cases of Butternut Diced 1" due to potential Salmonella contamination. The product was distributed to manufacturers and food service establishments in the Chicago, IL metro area.
Product
E-Z Spuds Inc. 10# Butternut Diced 1"
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0208-2022·2021-11-17
TRI-MIX Injectable Medication Recalled Due to Sterility Assurance Failure
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 INJ injectable medication because the manufacturer lacks assurance of sterility.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
HighFDA (Food)·F-0135-2022·2021-11-17
Ingredion Food Grade Starch Recall Due to Potential Metal Fragments
Ingredion Incorporated is recalling Ingredion INSTANT PURE-FLO F food grade starch (50 pound bags) because the product may contain metal fragments. The affected product was distributed to manufacturers and distributors across multiple states and countries.
Product
Ingredion INSTANT PURE-FLO F (50 pound bag) food grade starch material 12151103CA
Category
Food
Distribution
16 states
HighFDA (Devices)·Z-0204-2022·2021-11-17
McKesson Safety Blood Collection Needles Recalled for Safety Mechanism Defect
McKesson PREVENT HT Safety Blood Collection Needles are being recalled due to potential difficulty in activating the safety mechanism. The recall affects needles distributed nationwide, including specific lot numbers with expiration dates through May 2025.
Product
McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
Category
Medical Device
Distribution
Distributed nationwide