The Recall Desk

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.

1126–1150 of 3531

  • ModerateCPSC·24733·2023-12-07

    Bunkhouse and Lotsa LITES! Mini String Lights Recalled for Burn and Fire Hazards

    Bunkhouse and Lotsa LITES! Connectable Mini String Lights can overheat and present burn and fire hazards when plugged directly into an outlet. About 34,600 units are affected.

    Product
    Bunkhouse and Lotsa LITES! Connectable Mini String Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24728·2023-12-07

    Ergodyne Squids 3705 Wire Tool Attachments Recalled for Injury Hazard

    Ergodyne is recalling about 16,570 Squids 3705 Wire Tool Attachments because the wire can break when dropped while tethering a tool over two pounds, posing an injury risk to bystanders below.

    Product
    Squids 3705 Wire Tool Attachments - Screw Gate Tool Tail
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0403-2024·2023-12-06

    Medical device for hearing exams recalled for technical distortion issues

    PATH is recalling AuDX PRO hearing examination devices because they may produce technical distortions greater than expected, which could affect diagnostic accuracy. The recall affects 23 units distributed in Florida, Missouri, Ohio, and Wisconsin.

    Product
    AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0413-2024·2023-12-06

    TruWave Pressure Monitoring Set Recalled for Potential Flushing Difficulties

    Edwards Lifesciences is recalling 118,570 units of the TruWave Pressure Monitoring Set due to potential flushing difficulties during setup. The device is used for hemodynamic pressure monitoring.

    Product
    TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX600F (3cc), PXMK1876: x 3 (3 cc), PXMK1940: (3 cc), PXMK2024: (3cc)/77 in (196cm
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-0412-2024·2023-12-06

    FloTrac Pressure Monitoring Sensor Recalled for Setup Flushing Difficulties

    Edwards Lifesciences' FloTrac Sensor with Vamp System is being recalled due to potential flushing difficulties during setup of the pressure monitoring kit. No injuries have been reported.

    Product
    FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Drugs)·D-0127-2024·2023-12-06

    Testosterone Gel Recalled for Out-of-Specification Viscosity

    Teva Pharmaceuticals recalls specific lots of Testosterone Gel 1.62% for failing viscosity specifications. Patients should contact their healthcare provider to discuss the recall and obtain unaffected medication.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0129-2024·2023-12-06

    Paroxetine 20 mg Tablets Recalled for Out-of-Specification Impurity

    Golden State Medical Supply is recalling certain lots of Paroxetine 20 mg tablets nationwide due to an out-of-specification chemical impurity in the product.

    Product
    PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0408-2024·2023-12-06

    Iodine Solution Recalled for Improper Bottle Cap Seal

    EMD Millipore's Lugol's Iodine Solution (Lot 3124) is recalled due to an improper seal between the cap and bottle, which allows iodine vapors to dissipate and reduces the product's potency over time.

    Product
    Lugol s Iodine Solution 500ML, Part Number 624-71
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0120-2024·2023-12-06

    Paroxetine Tablets Recalled Due to Manufacturing Specification Failure

    Apotex Corp. is recalling Paroxetine Hydrochloride 20 mg tablets nationwide due to out-of-specification impurity levels in affected lots. No illnesses have been reported.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0125-2024·2023-12-06

    Compounded Ophthalmic Medication Bottles Mislabeled as Single-Use Syringes

    Fagron Compounding Services is recalling 756 bottles of compounded ophthalmic medication because labels incorrectly identify the container as a 0.5mL single-use syringe instead of a 5mL dropper bottle. No adverse events have been reported.

    Product
    Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, K
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0130-2024·2023-12-06

    Paroxetine 40 mg tablets recalled for out-of-specification impurities

    Golden State Medical Supply Inc. is recalling Paroxetine 40 mg tablets due to failed impurity specifications. A total of 5,626 bottles were distributed nationwide.

    Product
    PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0126-2024·2023-12-06

    VistaPharm Recalls Aminocaproic Acid Oral Solution Due to High Ethylene Glycol

    VistaPharm LLC is recalling Aminocaproic Acid Oral Solution (0.25 grams/mL) distributed nationwide due to high ethylene glycol content from failed manufacturing specifications. Four lot numbers are affected.

    Product
    Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0410-2024·2023-12-06

    Intravascular Pressure Sensor Recalled for Flushing Difficulties During Setup

    Edwards Lifesciences is recalling Acumen IQ intravascular pressure monitoring sensors (6,714 units) due to potential flushing difficulties during setup of the pressure monitoring kit.

    Product
    Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
    Category
    Medical Device
    Distribution
    51 states
  • ModerateCPSC·24032·2023-11-30

    Russound AW70V6 Loudspeakers Recalled for Impact Injury Hazard

    Russound is recalling Model AW70V6 loudspeakers because the front baffle can separate from the rear housing, causing the speaker to fall from its mounted location and create an impact injury hazard. One incident has been reported with no injuries.

    Product
    Russound Loudspeakers Model AW70V6
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24718·2023-11-30

    Supacaz Orbitron Bicycle Pedals Recalled for Fall Hazard

    Specialized Bicycle Components is recalling about 3,000 Supacaz Orbitron pedals because the pedal body can detach from the spindle or the spindle can break, posing a fall hazard. The company has received 21 reports of pedals breaking but no injuries have been reported.

    Product
    Supacaz Orbitron Pedals
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2024·2023-11-29

    Compress Device Short Anchor Plug recalled for potential metal burrs

    Biomet recalls Compress Device Short Anchor Plug devices due to potential metal burrs in transverse holes that may prevent proper drill and pin placement during orthopedic surgery, affecting units distributed worldwide.

    Product
    Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2024·2023-11-29

    Compress Device Short Anchor Plugs recalled due to metal burrs

    Biomet is recalling Compress Device Short Anchor Plugs (14 MM) due to potential metal burrs in transverse holes that may prevent proper insertion during surgery. The defect may extend surgical time.

    Product
    Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0462-2024·2023-11-29

    Frozen Gluten-Free Waffles Recalled for Potential Peanut Contamination

    Treehouse Foods is recalling multiple brands of frozen gluten-free blueberry waffles due to potential peanut contamination. Affected products were distributed in California, Iowa, Illinois, Ohio, and Texas.

    Product
    HEB Central Market Blueberry Buckwheat Gluten Free Waffle, 8.25oz, UPC 004122025365 Giant Eagle Blueberry Gluten Free Waffle, 11.3oz, UPC 030034944940 Topco Full Circle Market Gluten Free Waffles - Blueberry, 11.3oz, UPC 036800486980
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0463-2024·2023-11-29

    Dietary Supplement Recalled for Subpotent Folic Acid Content

    ActiPharma is recalling ACTIRON Dietary Supplement (Lot 13309, Exp. 01/26) distributed in Puerto Rico because FDA testing found the folic acid content did not meet the label claim.

    Product
    ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0114-2024·2023-11-29

    Lisinopril Tablets Recalled for Stray Amlodipine Tablet Contamination

    NCS Healthcare recalled Lisinopril Tablets USP 20 mg nationwide due to potential presence of stray Amlodipine Besylate 10 mg tablets in certain lots. No illnesses have been reported.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0112-2024·2023-11-29

    Prescription esomeprazole magnesium capsules recalled for failed impurity specifications

    Glenmark Pharmaceuticals recalled esomeprazole magnesium 20mg capsules nationwide due to out-of-specification organic impurities detected during stability testing. No illnesses have been reported.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0370-2024·2023-11-29

    Orthopedic Anchor Plugs Recalled for Metal Burrs Preventing Proper Installation

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent drills or pins from passing through, potentially extending surgical procedures.

    Product
    Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0411-2024·2023-11-22

    Shrimp product recall due to undeclared Red #40 food coloring

    ORALE! CAMARON NATURAL shrimp in 2 oz. packages (Lot F-219) is recalled due to undeclared Red #40 food coloring. Approximately 7,584 units were distributed domestically.

    Product
    ORALE! CAMARON NATURAL, NATURAL SHRIMP, NET WT. 2 OZ. 57 g (in paper cartons) (12 packages per case of 2 oz each), PACKED & DISTRIBUTED BY: LISY CORP., INGREDIENTS: Precooked Shrimp and Salt., UPC: 096786203209.
    Category
    Food
    Distribution
    0 states