The Recall Desk

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.

14551–14575 of 53092

  • HighFDA (Drugs)·D-0171-2023·2023-02-01

    Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution Specification

    Ascend Laboratories is recalling 2,628 bottles of Metoprolol Succinate Extended-Release Tablets (50 mg) nationwide due to failed dissolution specification. The tablets may not dissolve properly, preventing proper medication absorption.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0185-2023·2023-02-01

    Dutasteride Injectable Recalled for Lack of Sterility Assurance

    Pharmacy Innovations is recalling Dutasteride 0.1% injectable vials nationwide due to FDA-identified insanitary facility conditions that compromised sterility assurance. Patients should consult their healthcare provider about this prescription medication.

    Product
    Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0228-2023·2023-02-01

    Multiple injectable medications recalled for sterility assurance concerns

    Pharmacy Innovations recalls multiple injectable medications nationwide due to insanitary facility conditions compromising sterility assurance. FDA inspection revealed conditions creating risk to medication safety.

    Product
    PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT (1ML) 10MCG/30MG/2MG/ML INJECTABLE PE1/PAPAV/PHENT 10MCG/18MG/1MG/ML (1ML VIAL)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0205-2023·2023-02-01

    Pharmacy Innovations Recalls Estradiol Ophthalmic Solution Due to Sterility Concerns

    Pharmacy Innovations is recalling Estradiol 0.05% ophthalmic solution nationwide due to insanitary facility conditions that compromised sterility assurance. The FDA discovered the conditions during inspection.

    Product
    Estradiol 0.05% OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0215-2023·2023-02-01

    Injectable hydroxocobalamin vials recalled due to sterility concerns

    Pharmacy Innovations is recalling hydroxocobalamin-PF injectable vials (1mg/ml) distributed nationwide because FDA inspection found insanitary conditions at the manufacturing facility that could compromise product sterility.

    Product
    HYDROXOCOBALAMIN-PF- 1MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0201-2023·2023-02-01

    Dexamethasone Injectable and Ophthalmic Products Recalled for Sterility Concerns

    Pharmacy Innovations is recalling Dexamethasone injectable and ophthalmic solution products nationwide due to lack of sterility assurance. FDA inspection revealed insanitary conditions at the manufacturing facility.

    Product
    DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE; DEXAMETHASONE-PF- 0.1% (1ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0235-2023·2023-02-01

    FDA Recalls Scopolamine Ophthalmic Solution for Sterility Assurance Issues

    Pharmacy Innovations recalled Scopolamine Hydrobromide 0.25% ophthalmic solution nationwide due to FDA inspection findings of insanitary facility conditions that compromise sterility assurance.

    Product
    SCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0226-2023·2023-02-01

    FDA Recalls Papaverine/Phentolamine Injectable Vials Due to Sterility Concerns

    Pharmacy Innovations has recalled papaverine/phentolamine injectable vials in multiple concentrations due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.

    Product
    PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/1MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/2MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/3MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/5MG/ML (1ML…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0197-2023·2023-02-01

    Ceftazidime Injectable Recalled for Lack of Sterility Assurance

    Pharmacy Innovations is recalling Ceftazidime Intravitreal injectable nationwide due to lack of sterility assurance identified during FDA inspection of the manufacturing facility.

    Product
    Ceftazidime Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0193-2023·2023-02-01

    Pharmacy Innovations Apomorphine Injectable Recalled for Sterility Assurance Failure

    Pharmacy Innovations is recalling Apomorphine HCL 2MG/ML injectable vials nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.

    Product
    Apomorphine HCL 2MG/ML (10ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0220-2023·2023-02-01

    Injectable vitamin formulations recalled due to facility sterility concerns

    Pharmacy Innovations is recalling three injectable vitamin formulations due to insanitary facility conditions identified during FDA inspection that may affect product sterility.

    Product
    METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/METHYLCOBAL 15MG/50MG/100MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/RIBOFLA/NIACINAMIDE/PYRIDOX/ASCORBIC ACID…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2023·2023-02-01

    biokitHSV-2 Rapid Test Recalled for Potential False Positive Results

    The biokitHSV-2 Rapid Test has been recalled due to the potential for false positive results. The recall affects approximately 2,393 test kits distributed across NY, CA, IN, NC, and VA.

    Product
    biokitHSV-2 Rapid Test, REF: 300028001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0186-2023·2023-02-01

    Injectable chlorpheniramine/hyoscyamine recalled for sterility assurance failure

    Pharmacy Innovations has recalled Chlorpheniramine/Hyoscyamine injectable medication nationwide due to insanitary facility conditions identified during FDA inspection that compromise product sterility.

    Product
    Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0213-2023·2023-02-01

    Injectable drug product recalled due to sterility assurance failure

    Pharmacy Innovations is recalling injectable glycerin/lidocaine/epinephrine products nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.

    Product
    GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 48.7%(W/V)/0.67%/0.00067% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2023·2023-02-01

    FUSION Dual Pump Packs recalled for weld defect affecting surgery

    FUSION Dual Pump Packs are being recalled for weld defects that may impair vacuum delivery during eye surgery, risking surgical delays and corneal swelling. No injuries have been reported.

    Product
    FUSION Dual Pump Packs, REF: OPO73
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Drugs)·D-0217-2023·2023-02-01

    LEVEMIR insulin injection recalled for lack of sterility assurance

    LEVEMIR injectable insulin is being recalled nationwide due to insanitary facility conditions that compromise sterility assurance. FDA inspection identified conditions that may affect product safety.

    Product
    LEVEMIR-STS- 100U/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0210-2023·2023-02-01

    Glutathione Injectable and Inhalation Products Recalled Due to Sterility Assurance Failure

    Pharmacy Innovations is recalling multiple glutathione products due to insanitary facility conditions that compromise sterility assurance. The recall affects inhalation and injectable formulations distributed nationwide.

    Product
    GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0312-2023·2023-02-01

    Alsultan Sweets Mixed Baklava Recalled for Undeclared Milk and Wheat

    Alsultan Sweets Mixed Baklava is being recalled because the product contains undeclared milk and wheat allergens. Consumers with allergies should not consume this product.

    Product
    Alsultan Sweets Mixed Baklava 12.3oz (350 grams) UPC: 629700099929/750 grams UPC: 629700099912
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0225-2023·2023-02-01

    Injectable NADH Recalled for Sterility Concerns at Manufacturing Facility

    Pharmacy Innovations is recalling NADH 10MG/ML injectable vials distributed nationwide due to lack of assurance of sterility. FDA inspection revealed insanitary conditions at the facility.

    Product
    NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0200-2023·2023-02-01

    Pharmacy Innovations Cyclosporine Eye Drops Recalled for Sterility Defect

    Pharmacy Innovations is recalling Cyclosporine ophthalmic solutions (0.1%, 0.2%, 1%, 2%, and corn-oil-based 1%) due to lack of sterility assurance. FDA inspection found insanitary facility conditions.

    Product
    Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%; Cyclosporine (A) - Corn oil - 1% Oph solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2023·2023-02-01

    Ophthalmic solution recalled for lack of sterility assurance

    Pharmacy Innovations recalls a polyhexamethylene biguanide eye-drop solution nationwide due to insanitary manufacturing conditions. No illnesses have been reported.

    Product
    POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0320-2023·2023-02-01

    Chef Select Garlic Baguettes recalled for undeclared wheat and milk allergens

    Lidl US TRADING is recalling Chef Select 2 Garlic Baguettes (175 g) because they contain undeclared wheat and milk allergens. The product was distributed to stores in VA, MD, NC, GA, SC, PA, NJ, DE, NY, and Washington D.C.

    Product
    Chef Select 2 Garlic Baguettes filled With Garlic Butter 175 g Barcode: 4056489447559
    Category
    Food
    Distribution
    10 states
  • HighNHTSA·23V040000·2023-02-01

    2021 Volkswagen ID.4 Software Defect May Cause Loss of Drive Power

    Volkswagen is recalling 2021 ID.4 vehicles because a software defect in the battery management system may cause loss of drive power, increasing the risk of a crash. Free software updates will be provided by dealers.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0212-2023·2023-02-01

    Injectable Glycerin Sterile Recalled for Lack of Sterility Assurance

    Pharmacy Innovations is recalling Glycerin Sterile 99% Injectable (2ML and 5ML vials) nationwide. FDA inspection revealed insanitary facility conditions that compromise the product's sterility assurance.

    Product
    GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide