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.

17276–17300 of 53124

HighFDA (Drugs)·D-0917-2022·2022-06-01
Alpha Lipoic Acid injection vials recalled for sterility assurance defect
Olympia Compounding Pharmacy is recalling 3,286 vials of Alpha Lipoic Acid 25 mg/mL due to inability to assure sterility. Patients should contact their healthcare provider to verify their medication and discuss alternatives.
Product
Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0076-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0886-2022·2022-06-01
Losartan HCTZ drug recall due to azido impurity levels above limits
RemedyRepack Inc. is recalling Losartan HCTZ 100/25 mg tablets distributed in Florida, South Carolina, and Virginia due to azido impurity levels exceeding acceptable manufacturing limits.
Product
Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0942-2022·2022-06-01
FDA Recalls Olympia Vita-Complex Injection Due to Sterility Concerns
Olympia Compounding Pharmacy has recalled 8,664 vials of Olympia Vita-Complex B-vitamin injection nationwide due to lack of assurance of sterility. The affected multi-dose vials may pose an infection risk to patients who receive the product.
Product
Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5 P04 (B2) 2 mg/mL Dexpanthenol (B5) 2 mg/mL Pyridoxine HCL (B6) 2 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1086-2022·2022-06-01
Cole's Select Curry Salmon Rice Bowl Recall Due to Undeclared Allergens
Cole's Select Curry Salmon Rice Bowl is being recalled because salmon and soy ingredients are not declared on the label. Consumers with allergies to salmon or soy should not consume this product.
Product
Cole's Select Curry Salmon Rice Bowl, Green Curried Salmon Over Jasmine Rice, Net Wt. 8 oz., UPC 19962022057
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-1130-2022·2022-06-01
Invacare TDX SP2 Power Wheelchairs May Lose Power Due to Battery Harness Disconnection
Invacare TDX SP2 power wheelchairs may experience battery harness disconnection during shipment or use, resulting in loss of power. Approximately 133 affected devices have been distributed in the U.S. and Canada.
Product
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1123-2022·2022-06-01
Vanta INS Neurostimulator May Fail to Communicate with Programmer Systems
Medtronic has recalled certain Vanta INS Implantable Neurostimulator devices that may fail to communicate with clinical or patient programmer systems, preventing proper monitoring and therapy adjustments.
Product
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0920-2022·2022-06-01
Bimix-3 Injectables Recalled for Lack of Sterility Assurance
Bimix-3 compounded injectable (1,287 vials) recalled nationwide due to lack of sterility assurance. Patients should consult their healthcare provider about whether they received affected product.
Product
Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi-Dose Vial, NDC73198-0027-03; b) 10 mL Multi-Dose Vial, NDC 73198-0027-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1089-2022·2022-06-01
Mrs. Miller's Homemade Jam Spicy Chili Bacon Jam recalled for undeclared soy allergen
Mrs. Miller's Homemade Jam Spicy Chili Bacon Jam is being recalled for undeclared soy allergen. The product was distributed across 15 U.S. states. Consumers with soy allergies should not consume it.
Product
Mrs. Miller's Homemade Jam Spicy Chili Bacon Jam packaged into 9 oz glass jar 12 jars per case
Category
Food
Distribution
15 states
HighFDA (Devices)·Z-1136-2022·2022-06-01
Medical beds recalled for potential motorized wheel system failure
Umano Medical is recalling 355 adjustable medical beds because an electrical system component failure could cause the motorized wheel system to move uncontrollably, risking patient injury.
Product
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0914-2022·2022-06-01
Injectable Testosterone Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling 520 vials of Ultratest testosterone injectable due to lack of sterility assurance. The recall affects distribution nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
Ultratest Testosterone Cypionate 160 mg/mL Testosterone Propionate 40 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0058-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0898-2022·2022-06-01
RE-1 Compounded Injectable Medication Recalled Due to Sterility Assurance Issues
Olympia Compounding Pharmacy is recalling 482 vials of RE-1 (Papaverine, Phentolamine, Alprostadil) injectable medication due to lack of sterility assurance. Product was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Product
RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0897-2022·2022-06-01
QM-4 Compounded Injectable Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls QM-4, a multi-drug compounded injectable, due to lack of assured sterility. 914 vials distributed nationwide in the USA, Puerto Rico, and US Virgin Islands are affected.
Product
QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0020-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1140-2022·2022-06-01
Medical Calcium Reagent Shipped Without Required Refrigeration; QC Failure Risk
A medical lab reagent (ABX Pentra Calcium AS CP) was shipped at room temperature instead of refrigerated, causing probable quality control failure. Affected patients may experience diagnostic delays and require repeat testing.
Product
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-0921-2022·2022-06-01
Calcium Chloride Injectable Recalled for Sterility Assurance Concerns
Olympia Compounding Pharmacy is recalling 5,443 vials of Calcium Chloride 10% injectable due to lack of sterility assurance. The medication was distributed nationwide.
Product
Calcium Chloride 10% (100 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0064-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2022·2022-06-01
Medtronic Percept BrainSense Neurostimulator Cannot Communicate with Programmer Systems
Medtronic is recalling 14,164 Percept BrainSense Implantable Neurostimulators (Model B35200) worldwide because the devices cannot communicate with clinical or patient programmer systems, preventing proper device monitoring and adjustment.
Product
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1075-2022·2022-06-01
First & Ten Hot Sauce Recalled for Undeclared Milk Allergen
First & Ten Hot Sauce (11.5 oz bottles) is being recalled due to undeclared milk allergen. The product label declares butter but does not list milk as an allergen.
Product
First & Ten, Hot Sauce, NET WT. 11.5 OZ (326g), UPC code 195893089628
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-0908-2022·2022-06-01
Sodium Tetradecyl Sulfate Injection Recalled for Lack of Sterility Assurance
Olympia Pharmacy is recalling 588 vials of Sodium Tetradecyl Sulfate 5% injection nationwide due to inability to assure product sterility. The multi-dose vials carry a potential contamination risk for patients.
Product
Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0102-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0918-2022·2022-06-01
Preserved ascorbic acid recalled due to lack of sterility assurance
Olympia Compounding Pharmacy is recalling 7,420 vials of Preserved Ascorbic Acid due to lack of assurance of sterility. The injectable drug was distributed nationwide throughout the USA, Puerto Rico, and US Virgin Islands.
Product
Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0079-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0902-2022·2022-06-01
Sermorelin Acetate Injection Recalled Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Sermorelin Acetate injectable powder because of insufficient assurance of sterility. Patients using affected lots should contact their healthcare provider.
Product
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0923-2022·2022-06-01
Pyridoxine Injection Vials Recalled by FDA Due to Sterility Failure
Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine 100 mg/mL injectable due to lack of assurance of sterility. The multi-dose vials were distributed nationwide and may pose infection risk if administered.
Product
Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0066-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0892-2022·2022-06-01
Losartan Potassium and HCTZ Tablets Recalled for AZIDO Impurity Deviations
Preferred Pharmaceuticals is recalling specific lots of Losartan Potassium & HCTZ Tablets due to AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled tablets were distributed in Florida and California.
Product
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-1129-2022·2022-06-01
Percept PC BrainSense Implantable Neurostimulator Recalled for Communication Failure
Medtronic has recalled the Percept PC BrainSense Implantable Neurostimulator Model B35200 due to communication failures with programmer systems. The device cannot reliably communicate with clinical or patient programmer systems.
Product
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0910-2022·2022-06-01
Injectable T-106 Vials Recalled Due to Sterility Assurance Deficiency
Olympia Compounding Pharmacy recalls T-106 injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Product
T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Packaged as a) 5 mL Multi-Dose vial NDC 73198-0013-05; b) 10 mL Multi-Dose vial NDC 73198-0013-10, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1127-2022·2022-06-01
Teleflex Breathing Tubes Recalled Due to Reports of Tearing
Teleflex Medical Inc is recalling four models of breathing tubes following reports of torn corrugated tubes. Approximately 290,809 units are affected worldwide.
Product
(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0919-2022·2022-06-01
Compounded Injectable Drug Recalled Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling AT-6, a compounded injectable medication, due to lack of sterility assurance. The recall affects 528 vials from Lot K24409.
Product
AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0040-10
Category
Drug
Distribution
Distributed nationwide