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.

1226–1250 of 21710

  • ModerateFDA (Food)·H-0344-2026·2025-12-31

    Chaga mushroom supplement recalled over unapproved drug claims and misbranding

    A New Life Herbs is recalling 144 bottles of Chaga Mushroom Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.

    Product
    Chaga Mushroom Herbal Supplement, 1:5 Alcohol Double Extract, Supports a healthy immune system with anti-cancer properties; packaged in a 2 oz. glass dropper bottle, UPC 284588087831
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·H-0331-2026·2025-12-31

    Frozen French style puff pastry recalled over partially hydrogenated oils

    Karabetian Import and Distribution is recalling Zimi Puff Pastry French Style over partially hydrogenated oils in foods exported to the US.

    Product
    Product: Zimi Puff Pastry French Style (frozen) Package Size and quantity per case: 700 g paper carton - 12/case UPC: 5201592020017. Frozen.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·H-0341-2026·2025-12-31

    Baby Allergy herbal supplement recalled over unapproved drug claims and misbranding

    A New Life Herbs is recalling 23 bottles of Baby Allergy Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.

    Product
    Baby Allergy Herbal Supplement, Contains: Echinacea Purpurea, Oregon Grape Root, Dandelion & Burdock Root, Fenugreek, Ginger Root in vegetable glycerin; packaged in a 2 oz. glass dropper bottle, UPC 249953949282
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0995-2026·2025-12-31

    Transjugular liver access sets recalled over products manufactured out of specification

    Cook Incorporated is recalling 23 Rosch-Uchida Transjugular Liver Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.

    Product
    R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0993-2026·2025-12-31

    Check-Flo introducers recalled over products manufactured out of specification

    Cook Incorporated is recalling 7,952 Flexor Check-Flo Introducers and Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.

    Product
    Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFANL0-HC; 6) KCFW-12.0-35-45-RB-HFANL1-HC; 7)…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0332-2026·2025-12-31

    Ready to eat frozen kunefe recalled over partially hydrogenated oils

    Karabetian Import and Distribution is recalling Zimi Kunefe Ready to Eat over partially hydrogenated oils in foods exported to the US.

    Product
    Product: Zimi Kunefe Ready to eat (Frozen) Package Size and quantity per case: 380 g paper carton/tray - 9/case UPC: 5201592015822
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·H-0346-2026·2025-12-31

    Organic ginger root capsules recalled over unapproved drug claims and misbranding

    A New Life Herbs is recalling 48 bags of Organic Ginger Root Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.

    Product
    Organic Ginger Root Herbal Supplement, Natural anti-inflammatory properties, supports gut, increases circulation, 50 capsules/560 mg, packaged in a plastic bag
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·H-0345-2026·2025-12-31

    Mullein ear drops recalled over unapproved drug claims and missing supplement facts

    A New Life Herbs is recalling 22 bottles of Ear Drops Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.

    Product
    Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and antibiotic properties, packaged in a 0.5 oz. plastic dropper bottle
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0949-2026·2025-12-24

    Calf implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 35 AART Calf Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105…
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-0233-2026·2025-12-24

    Carbocaine dental cartridges recalled over cracked and broken containers

    Novocol Pharmaceutical of Canada is recalling 40 cartons of Cook-Waite Carbocaine 3% mepivacaine injection over a defective container with cracked or broken cartridges.

    Product
    CARBOCAINE — CARBOCAINE (MEPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0946-2026·2025-12-24

    Chin implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 29 AART Chin Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104…
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0945-2026·2025-12-24

    Gluteal implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 118 AART Gluteal Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103…
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0957-2026·2025-12-24

    Bone fixation screws recalled over a labeling error on one lot

    Smith & Nephew is recalling 168 BIOSURE HA Screws, 6mm x 20mm, due to a labeling error on the affected lot.

    Product
    BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0234-2026·2025-12-24

    Phentolamine mesylate injection recalled over cracked and broken cartridges

    Novocol Pharmaceutical of Canada is recalling 1,636 cartons of OraVerse (Phentolamine Mesylate) Injection over a defective container with cracked or broken cartridges.

    Product
    ORAVERSE — ORAVERSE (PHENTOLAMINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0238-2026·2025-12-24

    Cisatracurium 20 mg multiple-dose vials recalled after subpotent assay results

    Somerset Therapeutics is recalling 71,310 vials of Cisatracurium Besylate Injection, 20 mg/10 mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0935-2026·2025-12-24

    Ultrasound reporting software recalled over incomplete patient history information

    GE Healthcare is recalling 1,221 ViewPoint 6 systems because the Patient History tab in software versions 6.15.3 and 6.15.4 may not include complete patient medical history information.

    Product
    GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0232-2026·2025-12-24

    Benco mepivacaine cartridges recalled over cracked and broken containers

    Novocol Pharmaceutical of Canada is recalling Mepivacaine HCl 3% injection distributed by Benco Dental over a defective container with cracked or broken cartridges.

    Product
    MEPIVACAINE — MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0236-2026·2025-12-24

    Cisatracurium 10 mg vials recalled after subpotent stability assay results

    Somerset Therapeutics is recalling 52,340 vials of Cisatracurium Besylate Injection, 10 mg/5 mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2026·2025-12-24

    Children's mouthguards recalled for distribution without FDA premarket clearance

    Myofunctional Research Company USA is recalling 436 Myosa for Kids devices because the firm mistakenly distributed the product within the US without FDA premarket clearance or approval.

    Product
    Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0948-2026·2025-12-24

    Pectoral implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 41 AART Pectoral Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2…
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0942-2026·2025-12-24

    Sputum transfer reagent sets recalled because liquification cannot be guaranteed

    Copan Italia is recalling 122,850 units of 1ml DTT reagent supplied with a sputum transfer device because treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

    Product
    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0947-2026·2025-12-24

    Malar facial implants recalled over specification deviations and missing clearance

    DSAART is recalling 2 AART Malar Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0944-2026·2025-12-24

    Silicone carving implants recalled over specification deviations and missing clearance

    DSAART is recalling 369 AART Silicone Carving Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone…
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0943-2026·2025-12-24

    Respiratory specimen reagent recalled because fluidification cannot be guaranteed

    Copan Italia is recalling 122,850 units of 1ml DTT liquid reagent because treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

    Product
    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0240-2026·2025-12-24

    Ciclopirox shampoo recalled after failing impurity specifications at eighteen months

    Sun Pharma/Taro is recalling 17,664 units of Ciclopirox Shampoo 1% after out of specification impurity and degradation results at the 18-month timepoint.

    Product
    Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
    Category
    Drug
    Distribution
    Distributed nationwide