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.

976–1000 of 3531

  • ModerateFDA (Devices)·Z-1086-2024·2024-02-21

    Quidel Sofia 2 Flu + SARS Test Kits Recalled for Incorrect Expiration Dates

    Quidel Corporation is recalling one lot of Sofia 2 Flu + SARS Antigen FIA diagnostic test kits due to incorrect expiration dates on packaging. Kits labeled to expire April 30 and May 31, 2025 actually expire September 12, 2024.

    Product
    The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0324-2024·2024-02-21

    HydrALAZINE Hydrochloride Tablets Recalled for Out-of-Specification Impurities

    HydrALAZINE Hydrochloride Tablets Lot T04680 are recalled for out-of-specification impurities found during routine testing. No illnesses have been reported, but the product poses a remote risk of reversible effects.

    Product
    HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0314-2024·2024-02-14

    Prescription Drug Febuxostat Recalled Due to Manufacturing Practice Violations

    Amerisource Health Services LLC is recalling approximately 1,932 cartons of Febuxostat (40 mg tablets) nationwide due to deviations from current good manufacturing practices. The firm initiated the recall voluntarily on January 25, 2024.

    Product
    FEBUXOSTAT — FEBUXOSTAT (FEBUXOSTAT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1004-2024·2024-02-14

    Olympus Paparella-Type Vent Tube Recall: Missing Expiration Date on Inner Packaging

    Olympus Corporation of the Americas is recalling one lot of Paparella-Type Vent Tubes due to missing expiration date on the inner package, though the date is present on the outer packaging.

    Product
    Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0837-2024·2024-02-14

    Galbani Domestic Mascarpone recalled due to improper storage temperature

    Galbani Domestic Mascarpone (1/5# cases) distributed in Ohio, New York, and Pennsylvania is recalled due to improper temperature storage. The temperature control failure could affect product spoilage and potentially support pathogen growth.

    Product
    GALBANI DOMESTIC MASCARPONE 1/5# SUPC/ITEM # 19641
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0998-2024·2024-02-14

    Sperm separation media kits recalled for incorrect component lot

    Fujifilm is recalling sperm separation media kits because the lower layer component may not match the documented lot. The kits may contain an older component with a different shelf life, which could affect product performance.

    Product
    Sperm separation media are used to separate motile sperm from other constituents of semen.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Drugs)·D-0320-2024·2024-02-14

    Hydralazine Hydrochloride Tablets Recalled Due to Failed Purity Tests

    Amerisource Health Services is recalling HydrALAZINE Hydrochloride Tablets (10 mg) due to failed impurity specifications discovered during 6-month stability testing.

    Product
    HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0859-2024·2024-02-14

    Phosphatidyl Serine Softgels Recalled for Understated Ingredient Concentration

    Now Foods has recalled Phosphatidyl Serine 300mg softgels due to lower actual ingredient content than labeled. The recall affects 12,051 bottles distributed nationwide and internationally.

    Product
    Protocol for Life Balance, Phosphatidyl Serine 300mg softgels, 50 count bottle, UPC 707359123922. NOW Foods, Phosphatidyl Serine 300mg softgels, 50 count bottle, UPC 733739023926.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0856-2024·2024-02-14

    Popcorn Pre-Pop Recalled Due to Undeclared Yellow #5 Dye

    County Fair Foods is recalling 42,000 bags of Popcorn Pre-Pop nationwide due to undeclared Yellow #5 dye. The voluntary recall was initiated because Yellow #5 was not declared on the product label.

    Product
    Popcorn Pre-Pop in 8oz Polypropylene bag packaged 20 bags to a case
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0312-2024·2024-02-14

    FDA Recalls Glimepiride Tablets for Misprint on Tablet

    Dr. Reddy's Laboratories is recalling Glimepiride 1mg tablets due to a misprint on the tablet. The recall affects 59,336 bottles distributed nationwide.

    Product
    GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0313-2024·2024-02-14

    Prescription Glimepiride Tablets Recalled Due to Tablet Misprint

    Dr. Reddy's Laboratories is recalling Glimepiride 1mg tablets nationwide due to a printing defect on the tablet. The voluntary recall affects 14,425 bottles.

    Product
    GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0821-2024·2024-02-14

    President Goat Cheese Recalled Due to Improper Storage Temperature

    Greco Sidari is recalling President Goat Cheese (1375 cases) distributed in Ohio, New York, and Pennsylvania between November 26, 2023 and January 5, 2024 due to improper storage temperature that could support pathogen growth.

    Product
    PRESIDENT GOAT CHEESE 3/1KG SUPC/ITEM # 6159
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0315-2024·2024-02-14

    Medline Antifungal Cream Recalled for False Paraben-Free Labeling

    Medline Remedy Clinical antifungal cream is recalled for labeling that falsely claims to be paraben-free while the product actually contains parabens. About 1,786 tubes nationwide are affected.

    Product
    MEDLINE — MEDLINE (MICONAZOLE NITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1053-2024·2024-02-14

    Bubble Sensor for CARDIOHELP-i system has incorrect device identifier on label

    Maquet Medical Systems is recalling the Bubble Sensor accessory for CARDIOHELP-i extracorporeal life support systems due to an incorrect UDI Device Identifier printed on the product label.

    Product
    Bubble Sensor (REF: 70105.5720)
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0964-2024·2024-02-07

    Blood Culture Bottle Kit Recalled for Expired Component Documentation Issue

    Medline is recalling blood culture bottle kits with mismatched component expiration date documentation, creating risk of using expired components if not verified by users.

    Product
    MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0966-2024·2024-02-07

    Medline Blood Culture Collection Kit Recalled for Undocumented Component Expiration

    Medline is recalling blood culture collection kits because the Bactec component expiration date is not documented on the kit insert. Users who do not check the component directly risk using an expired element.

    Product
    MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0803-2024·2024-02-07

    Solgar Glucosamine Chondroitin Recalled Due to Wrong Product Packaging Error

    Nestle Health Science recalled Solgar Glucosamine Chondroitin (120-tablet bottles) distributed in six states due to a packaging error where Megasorb B-Complex was filled into mislabeled bottles.

    Product
    Solgar, Triple Strength, Shellfish -Free, Glucosamine Chondroitin MSM, 120 Tablets per bottle. Glass Bottle, 12 per Case, Store at room temperature . Product Number -1319
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Food)·F-0802-2024·2024-02-07

    Milk N Cookies Keto Brick recalled for undeclared MCT oil and acacia fiber

    Savage Sports LLC is recalling Milk N Cookies Keto Brick due to undeclared MCT oil and acacia fiber in the formulation. Approximately 7,461 units distributed via the company's website are affected.

    Product
    Milk N Cookies Keto Brick / 1 Brick, 145g 5.1 oz
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0969-2024·2024-02-07

    Medline Blood Culture Tray Adult recalled for incomplete component labeling

    Medline recalls Adult Blood Culture Trays due to incomplete documentation of Bactec component expiration dates on kit inserts. Users should verify the component expiration date before use.

    Product
    MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2024·2024-02-07

    Medline Blood Culture Kits recalled for inaccurate expiration dating

    Medline recalls Blood Culture Kits because kit inserts fail to reflect the expiration date of included Bactec components. Users could unknowingly use expired components if they don't independently check the Bactec label.

    Product
    MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0866-2024·2024-02-07

    Surgical needle holders distributed with incorrect product labels

    Aesculap Inc is recalling 53 JACOBSON DUROGRIP TC micro needle holders that were shipped with incorrect product labels, which may cause delays during surgical procedures.

    Product
    MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0287-2024·2024-02-07

    Hydrogen Peroxide Oral Rinse Recalled for Manufacturing Deviations

    Den-Mat Holdings recalls Hydrogen Peroxide Oral Rinse products nationwide due to manufacturing deviations that may result in products not conforming to labeled specifications.

    Product
    Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0868-2024·2024-02-07

    TERUMO HydroPearl embolization microspheres recalled for manufacturing process deviation

    MICROVENTION is recalling TERUMO HydroPearl Compressible Microspheres because manufacturing and quality processes were not followed during production. The recall affects 22 units distributed in seven U.S. states.

    Product
    TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0837-2024·2024-02-07

    FDA Recalls Terragene Bionova PCD Device Due to Instructions Discrepancy

    Terragene S.A. is recalling Terragene Bionova PCD (Model PCD222-C) medical devices nationwide due to a discrepancy between FDA-cleared instructions for use and the actual instructions distributed with the products.

    Product
    Terragene Bionova PCD (PCD222-C)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·24106·2024-02-01

    Glass Little Wanderer Snow Globes Recalled for Laceration Hazard

    The Museum of Modern Art is recalling about 1,915 glass Little Wanderer snow globes sold at MoMA Design Stores because they can crack or fracture, posing a laceration hazard. No injuries have been reported.

    Product
    Snow globes (Little Wanderer)
    Category
    Consumer Product
    Distribution
    Distributed nationwide