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.

1726–1750 of 21710

  • ModerateFDA (Food)·H-0594-2025·2025-09-24

    Quercetin tablets recalled over unapproved drug claims and misbranding on label

    Hi-Tech Pharmaceuticals Quercetin, 120 tablets, lot C1612, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.

    Product
    HI-TECH PHARMACEUTICALS QUERCETIN STRENGTHENS IMMUNE SYSTEM SUPPORTS RESPIRATORY HEALTH SUPPORTS CARDIOVASCULAR HEALTH 120 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02491 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Food)·H-0590-2025·2025-09-24

    Joint supplement recalled over unapproved drug claims on the label

    Hi-Tech Pharmaceuticals Joint-RX dietary supplement, 90 count, lot 503110607, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.

    Product
    HI-TECH PHARMACEUTICALS JOINT-RX DIETARY SUPPLEMENT 600mc Helps Rebuild Cartilage & Ease Pain Revolutionary Joint Support System 90CT UPC 8 57084 00035 4 Hi-Tech Pharmaceuticals, Inc. 6015-B Unity Dr Norcross, GA 30071
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-2585-2025·2025-09-24

    Blood gas EG6+ cartridges recalled for lacking updated premarket clearance

    i-STAT EG6+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 547,250 units are affected.

    Product
    i-STAT EG6+ cartridge. List Number: 03P77-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2584-2025·2025-09-24

    Blood gas EG7+ cartridges recalled for lacking updated premarket clearance

    i-STAT EG7+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 6,115,950 units are affected.

    Product
    i-STAT EG7+ cartridge. List Number: 03P76-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2560-2025·2025-09-24

    Lactate slides in 18-slide cartridges recalled over calibration failures delaying results

    VITROS Chemistry Products LAC Slides, catalog 8150112, from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,320 units are affected.

    Product
    VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0598-2025·2025-09-24

    Taurine powder recalled over unapproved drug claims and misbranding

    PrimeNutrition Taurine, 8.12 oz, lot 710581618, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.

    Product
    PRIMENUTRITION TAURINE MENTAL & ATHLETIC PERFORMANCE 125 SERVINGS SUPPORTS ENERGY PRODUCTION PROTEN ANTIOXIDANT PROPERTIES SUPPORTS HEALTHY BLOOD SUGAR LEVELS NET WT. 8.12OZ (250g) DIETARY SUPPLEMENT UPC 6 89466 70601 7 Manufactured by: Prime Nutrition 6015-B Unity Drive…
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-2582-2025·2025-09-24

    Blood gas cartridges recalled for lacking clearance covering updated measurement ranges

    i-STAT CG4+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting the updated lactate sample type and pH and PO2 measurement ranges. 9,067,050 units are affected.

    Product
    i-STAT CG4+ cartridge (white). List Number: 03P85-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2577-2025·2025-09-24

    Twelve millimetre distraction pins recalled over unvalidated shelf life labeling

    Frontier Devices 12 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated. 160 units are affected.

    Product
    Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2580-2025·2025-09-24

    Distraction pins in double packs recalled over unvalidated shelf life labeling

    Frontier Devices 14 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated.

    Product
    Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2576-2025·2025-09-24

    Distraction pins in single packs recalled over shelf life that was not validated

    Frontier Devices 12 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 3,790 units are affected.

    Product
    Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·25V629000·2025-09-19

    Altec certification labels may list an incorrect axle weight rating

    Altec is recalling certain 2022-2025 Aerial Device, Forestry Body, Service Body and Digger Derrick vehicles because the Gross Axle Weight Rating on the certification label may be incorrect.

    Product
    ALTEC — ALTEC DIGGER DERRICK, FORESTRY BODY, AERIAL DEVICE, SERVICE BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0624-2025·2025-09-17

    Major Pharmaceuticals antibiotic cartons recalled over micro-organism on packaging coil

    Sulfamethoxazole and Trimethoprim double strength unit dose cartons from Major Pharmaceuticals are recalled because a micro-organism was found on a lot of packaging coil. No micro-organism was detected on any tablets.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0573-2025·2025-09-17

    WINN-50 dietary supplement recalled after testing subpotent for vitamin B12

    Anabolic Research WINN-50, 90 capsules, lot 2307149, is recalled nationwide because degradation of an ingredient left the product subpotent for vitamin B12. 1,566 bottles are affected.

    Product
    Anabolic Research WINN-50 (vanazolol). Dietary Supplement. 90 Capsules. UPC 8 51840-00707 6. Manafactured For: Anabolic Research, 6942 FM 1960 E. #346, Humble, TX 77346-2706.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0629-2025·2025-09-17

    Neuroquell products recalled over current good manufacturing practice violations

    Neuroquell and Neuroquell Plus, 0.22 fl oz, distributed by Claire Ellen Products, are recalled for cGMP violations. 72 containers sold via the internet are affected.

    Product
    Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0622-2025·2025-09-17

    First aid iodine antiseptic recalled over broken or leaking bottles

    Iodo Blanco Iodides First Aid Antiseptic, iodine 2%, lot 230619, is recalled because of a defective container: broken or leaking bottles. 3,900 bottles distributed in Florida are affected.

    Product
    Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distributed by: Essential Products, www.essentialproductsusa.com, NDC: 70242-109-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2552-2025·2025-09-17

    Measles IgM test kits recalled for lacking premarket approval or clearance

    ReQuest Measles IgM ELISA kits, catalog number 01-190M, are recalled because the test kit lacks premarket approval or clearance. 376 kits are affected.

    Product
    Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2555-2025·2025-09-17

    Intervertebral fusion implants recalled over incorrect width printed on side labels

    PILLAR SA Ti sterile 37 mm intervertebral body fusion devices are recalled because the outer and inner label side flaps state an incorrect width of 33 mm. 3 units are affected.

    Product
    PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2551-2025·2025-09-17

    Preventive maintenance kit recalled over loosely tightened desiccant tube end caps

    The Preventive Maintenance Kit ICEFX, batch 108159110, is recalled because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. One unit is affected.

    Product
    Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0625-2025·2025-09-17

    Cardinal Health antibiotic tablets recalled over micro-organism on packaging coil

    Sulfamethoxazole and Trimethoprim double strength tablets distributed by Cardinal Health are recalled because a micro-organism was found on a lot of packaging coil. No micro-organism was detected on any tablets.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0626-2025·2025-09-17

    Ciprofloxacin and dexamethasone otic suspension recalled following temperature abuse

    Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, lot VNF35A, distributed by Sandoz, is recalled because of temperature abuse. 1,680 bottles went to a single consignee in California.

    Product
    CIPROFLOXACIN AND DEXAMETHASONE — CIPROFLOXACIN AND DEXAMETHASONE (CIPROFLOXACIN AND DEXAMETHASONE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2537-2025·2025-09-17

    Surgical matrix patches recalled for labeling correction on wound dehiscence management

    CorNeat EverPatch permanent tissue-integrating surgical matrices are the subject of a retroactive labeling correction, following complaints, to include prevention and management of wound dehiscence.

    Product
    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2550-2025·2025-09-17

    Cryoablation systems recalled over desiccant tube caps that were not tightened

    ICEfx Cryoablation Systems are recalled because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. 18 units are affected.

    Product
    ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0579-2025·2025-09-17

    Bulk mint chip ice cream recalled after elevated coliform counts found

    Hershey's Ice Cream Green Mint Chip bulk 3-gallon cans, lot 25223M, are recalled after routine testing found elevated coliform counts. 81 cans are affected.

    Product
    Hershey s Ice Cream, Green Mint Chip (GMC) Bulk, 3 gallons, 1 unit , bulk can- a cardboard tub with metal rings and cardboard lid
    Category
    Food
    Distribution
    7 states