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.

17001–17025 of 53124

  • HighFDA (Drugs)·D-0996-2022·2022-06-15

    Topex Benzocaine Topical Anesthetic Recalled for Temperature-Abuse Manufacturing Deviation

    McKesson Medical-Surgical is recalling Topex benzocaine 20% topical anesthetic gel due to cGMP deviations involving temperature abuse during manufacturing. The recall affects 24 bottles distributed nationwide.

    Product
    Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer: DS Healthcare, NDC 0699-5116-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0991-2022·2022-06-15

    Walgreens Earache Drops recalled for microbial contamination of non-sterile product

    Walgreens Earache Drops are recalled due to microbial contamination in the non-sterile product. Consumers should stop using the product and consult a healthcare provider if they experience any adverse effects.

    Product
    WALGREENS EARACHE DROPS — WALGREENS EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1110-2022·2022-06-15

    FDA Recalls Metoprolol Tablets Due to Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Metoprolol 50 mg tablets nationwide due to temperature abuse during manufacturing that may compromise medication stability. Patients should contact their pharmacist or physician.

    Product
    Metoprolol tablets 50 mg, 100-count botte, Rx only, MFG: Sun Pharmaceuticals, NDC 57664-0477-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1246-2022·2022-06-15

    Siemens Artis Icono Angiography Systems Pose Electric Shock Risk

    Siemens Artis icono angiography systems may pose electric shock risk if protective grounding is interrupted. Affected units sold nationwide; users should verify equipment grounding integrity.

    Product
    Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1026-2022·2022-06-15

    Apraclonidine ophthalmic solution recalled for temperature-abuse manufacturing defect

    McKesson Medical-Surgical is recalling 21 bottles of Apraclonidine 0.5% ophthalmic solution due to cGMP deviations involving temperature abuse during manufacturing. The temperature exposure may reduce drug efficacy.

    Product
    APRACLONIDINE — APRACLONIDINE (APRACLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1300-2022·2022-06-15

    Frigo Mozzarella Cheese recalled for undeclared milk allergen

    Frigo Low Moisture Mozzarella Cheese is being recalled because milk is not declared on the label. Consumers with milk allergies may be affected.

    Product
    Frigo Part-Skim Low Moisture Part Skim Mozzarella Cheese Net Wt. 2lb. (907g) Saputo Cheese USA, Inc. Lincolnshire, IL 60069 UPC: 041716131138
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1035-2022·2022-06-15

    Ophthalmic Drug Isopto Atropine Recalled Due to Manufacturing Temperature Deviation

    McKesson Medical-Surgical is recalling 13 bottles of Isopto Atropine 1% ophthalmic solution due to temperature-abuse violations of manufacturing standards that may have affected product sterility.

    Product
    ISOPTO ATROPINE — ISOPTO ATROPINE (ATROPINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2022·2022-06-15

    Siemens Artis icono Angiography Systems: Risk of Electric Shock from Grounding Failure

    Siemens is recalling 51 Artis icono biplane angiography systems due to a potential grounding failure that could allow electric shock if someone contacts metallic parts during use.

    Product
    Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2022·2022-06-15

    MedMinder Medication Dispenser Emergency Alert Function No Longer Operational

    MedMinder Medication Dispensers will no longer connect to the emergency alert system for all models. The device's emergency communication capability has been discontinued for approximately 2,701 units nationwide.

    Product
    MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to communicate with emergency call center.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1229-2022·2022-06-15

    Elite Mini Mix Chocolate recalled for potential Salmonella contamination

    Elite Mini Mix Chocolate products are being recalled for potential Salmonella contamination. The FDA Class I recall affects all lots distributed nationwide.

    Product
    ELITE MINI MIX CHOCOLATE UPC:77245111303 NET WT. 14.11 (400 g). Mixed Bag ELITE MINI MIX CHOCOLATE BAR UPC:815871012959 NET WT. 13.75oz (390 g). Mixed bag.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1042-2022·2022-06-15

    FDA Recalls Olanzapine Tablets Due to Temperature Abuse in Manufacturing

    McKesson Medical-Surgical is recalling Olanzapine Orally Disintegrating Tablets 10 mg nationwide due to temperature abuse during manufacturing that may have affected product stability. Patients should consult their healthcare provider about their medication.

    Product
    Olanzapine Orally Disintegrating Tablets, USP 10 mg, 30-count box unit dose tablets (3 blister cards each containing 10 tablets), Rx only, MFG: PAR PHARMA, NDC 49884-321-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1029-2022·2022-06-15

    Ciprofloxacin eye drops recalled due to manufacturing temperature deviations

    McKesson is recalling Ciprofloxacin Ophthalmic Solution 0.3% nationwide due to temperature deviations during manufacturing. The FDA classifies this as a Class II recall.

    Product
    Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc., NDC 61314-0656-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1044-2022·2022-06-15

    Prescription ciprofloxacin eye drops recalled for temperature abuse manufacturing deviation

    McKesson Medical-Surgical is recalling Ciprofloxacin Hydrochloride 0.3% ophthalmic solution nationwide due to temperature abuse, a cGMP violation that may compromise product integrity.

    Product
    CIPROFLOXACIN HYDROCHLORIDE — CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1122-2022·2022-06-15

    Paracentesis Tray with Lidocaine Recalled for Temperature Abuse

    McKesson Medical-Surgical is recalling Paracentesis/Thoracentesis Trays that were subjected to temperature abuse during distribution, which may compromise the sterility and efficacy of the included Lidocaine Hydrochloride. No illnesses have been reported.

    Product
    Paracentesis/Thoracentises Tray (10/cs) Rx CRFPED, Lidocaine Hydrochloride USP, 1%, 5mL, Rx only, MFG: Becton Dickinson
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1016-2022·2022-06-15

    Firmagon Degarelix Injection Recalled for Temperature Abuse During Distribution

    McKesson Medical-Surgical is recalling 15 boxes of Firmagon degarelix injection due to temperature abuse during distribution. The temperature exposure may compromise the pharmaceutical's stability and safety.

    Product
    Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8403-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0998-2022·2022-06-15

    Bupivacaine Hydrochloride Injection Recalled for Temperature Storage Deviations

    McKesson Medical-Surgical is recalling Bupivacaine Hydrochloride Injection due to temperature abuse during storage that may have compromised product sterility. The recall affects 224 cartons distributed nationwide.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1154-2022·2022-06-15

    Dietary supplement gummies recalled for potential undeclared gluten

    Supple Bears Quercetin Bromelain Gummies are recalled because they are labeled as gluten-free but may contain gluten. Consumers with celiac disease or gluten sensitivity should not use this product.

    Product
    SUPPLE BEARS QUERCETIN BROMELAIN GUMMIES + Vitamin C & Zinc 60 DIETARY SUPPLEMENTS NO SOY, NO GLUTEN, NO EGGS, NO DIARY, NO NUTS, NO GELATIN, NO ARTIFICIAL COLOR, FLAVOR OR SWEETENER, NO PRESERVATIVES. Dist. & Sold Exclusively By: SuppleBears 14311 Reese Blvd STE Huntersville…
    Category
    Food
    Distribution
    8 states
  • HighFDA (Drugs)·D-0989-2022·2022-06-15

    Homeopathic Ear Drops Recalled Due to Microbial Contamination Risk

    EAR CARE EARACHE DROPS are being recalled nationwide due to potential microbial contamination. Rite Aid is recalling 16,374 bottles of the homeopathic otic product.

    Product
    EAR CARE EARACHE DROPS — EAR CARE EARACHE DROPS (ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFUR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1178-2022·2022-06-15

    Milk chocolate bar recalled nationwide for potential Salmonella contamination

    Elite Popping Rocks Milk Chocolate Bar (UPC 815871010337) is being recalled nationwide due to potential Salmonella contamination. All lots are affected.

    Product
    ELITE POPPING ROCKS MILK CHOCOLATE BAR UPC:815871010337 Net Wt. 3.53 oz (100g). Red packaging.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1004-2022·2022-06-15

    Lidocaine Patch 5% Recalled for Temperature Exposure During Distribution

    McKesson Medical-Surgical is recalling Lidocaine Patch 5% due to temperature abuse during storage and distribution. Affected patches may not function properly. Patients should consult their healthcare provider.

    Product
    Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceuticals, NDC 42858-0118-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2022·2022-06-15

    Reliance Synergy Washer/Disinfector fire hazard due to electrical contactor malfunction

    Steris Corporation is recalling Reliance Synergy Washer/Disinfector units due to a malfunctioning electrical contactor that can cause heating elements to overheat, creating a fire risk. Affected units may generate smoke and fire in the drying chamber.

    Product
    Reliance Synergy Washer/Disinfector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1071-2022·2022-06-15

    MethyLPREDNISolone Acetate Injectable Suspension Recall Due to Temperature Abuse

    McKesson Medical-Surgical is recalling MethyLPREDNISolone Acetate Injectable Suspension due to temperature abuse during storage that may compromise sterility and efficacy. The recall affects 65 vials distributed nationwide.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension, USP, 200mg/5mL (40 mg/mL), 5 mL multi-dose vial, Rx only, MFG: Teva Pharma USA, NDC 0703-0043-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0994-2022·2022-06-15

    FDA Class II Recall: Miochol E Intraocular Solution Due to Temperature Exposure

    McKesson is recalling Miochol E intraocular solution due to temperature abuse during distribution. The product should not be used if received between June 1 and September 30, 2021.

    Product
    MIOCHOL E — MIOCHOL E (ACETYLCHOLINE CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1034-2022·2022-06-15

    FDA Recalls BSS Sterile Irrigating Solution for Manufacturing Temperature Deviations

    McKesson Medical-Surgical is recalling BSS sterile irrigating solution nationwide due to cGMP deviations involving temperature abuse during manufacturing. The recall affects prescription-only ophthalmic solutions.

    Product
    BSS — BSS (BALANCED SALT SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide