The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

5876–5900 of 88106

  • HighFDA (Drugs)·D-0074-2026·2025-10-15

    Exosome reconstitution solution recalled across all lots over sterility assurance

    GenoGenix is recalling Elite Stack MSC Exosome Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0019-2026·2025-10-15

    Meal replacement protein powder recalled for undeclared milk across many lots

    New Spirit Naturals is recalling 79 containers of Meal In A Glass protein powder in vanilla, chocolate and strawberry because the product contains undeclared milk.

    Product
    Meal In A Glass protein powder. 1.05 lbs and 4.5 lbs container. UPC: NA Vanilla, Chocolate and Strawberry flavor.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0070-2026·2025-10-15

    Zinc sulfate injection recalled across all lots for sterility assurance concerns

    GenoGenix is recalling Zinc Sulfate for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0013-2026·2025-10-15

    Wheat pellet pasta recalled for missing ingredient list and nutrition panel

    El Rojo Wholesale is recalling 2,904 units of El Rojo Pasta De Harina wheat pellets because the pack has no ingredient list, leaving wheat and Yellow No. 6 undeclared.

    Product
    El Rojo Pasta De Harina, Wheat Pellets. Net Wt 8 oz. (225g) UPC 0 35579-80871 6. Packaged and distributed by: El Rojo Wholesale, Maple Grove, MN 55469.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0130-2026·2025-10-15

    Larger nasal feeding tubes recalled because distal tips may detach

    Applied Medical Technology is recalling 200 NutraGlide 5 F - 8 F nasal feeding tubes whose distal tips may detach at lower than expected forces.

    Product
    NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0039-2026·2025-10-15

    Ocular surgical matrix recalled after complaints of early patch exposure

    CorNeat Vision is recalling 630 CorNeat EverPatch units after reviewed complaints identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

    Product
    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2026·2025-10-15

    Medical imaging servers recalled over security vulnerability affecting patient data

    GE is recalling 7,302 AW Server systems after identifying a security vulnerability that, if exploited, could compromise the confidentiality, integrity and availability of patient data.

    Product
    AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2026·2025-10-15

    Preserved glutathione injection recalled across all lots for sterility assurance

    GenoGenix is recalling Glutathione Preserved for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0043-2026·2025-10-15

    Methylcobalamin B12 injection recalled across all lots over sterility assurance

    GenoGenix is recalling B12 Methylcobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as, manufactured for Synergy Wellness.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0069-2026·2025-10-15

    Vitamin D3 for injection recalled across all lots over sterility assurance

    GenoGenix is recalling Vitamin D3 for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0012-2026·2025-10-15

    Bee pollen jars recalled after detectable pyrrolizidine alkaloids were found

    Sadecki Bartnik is recalling 336 jars of Pylek Kwiatowy bee pollen distributed in Illinois because of detectable pyrrolizidine alkaloids.

    Product
    Sadecki Bartnik Pylek Kwiatowy (Bee Pollen) 200g (7.05oz) glass jar UPC 5 900597 000788
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0081-2026·2025-10-15

    Reconstitution XO solution recalled across all lots over sterility assurance

    GenoGenix is recalling Reconstitution XO Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20%…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0079-2026·2025-10-15

    Proline injection recalled across all lots for lack of sterility assurance

    GenoGenix is recalling Proline for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0068-2026·2025-10-15

    Ultra Burn injection recalled across all lots over lack of sterility

    GenoGenix is recalling Ultra Burn for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0073-2026·2025-10-15

    EDTA for injection recalled across all lots over sterility assurance

    GenoGenix is recalling EDTA for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0051-2026·2025-10-15

    Copper peptide injection recalled across all lots for sterility assurance concerns

    GenoGenix is recalling GHK-Cu (Copper Peptide) for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0016-2026·2025-10-15

    Bulk Madison mix recalled for missing label and four undeclared allergens

    Egress Capital Partners is recalling 3,547 cases of Taproom Gourmet 15 lb bulk Madison Mix because the product has no ingredient label and contains undeclared peanuts, almonds, wheat and soy.

    Product
    Taproom Gourmet brand 15lb bulk "Madison" Mix
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0087-2026·2025-10-15

    Thymosin Beta-4 injection recalled from one lot over sterility assurance

    GenoGenix is recalling Thymosin Beta-4 (TB4) for Injection, 15mg, in all presentations from a single lot for lack of assurance of sterility.

    Product
    Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0086-2026·2025-10-15

    BPC-157 with Thymosin Beta-4 recalled from three lots over sterility

    GenoGenix is recalling combined BPC-157/Thymosin Beta-4 for Injection across three lots for lack of assurance of sterility.

    Product
    BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI).
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0056-2026·2025-10-15

    L-Arginine HCl injection recalled across all lots over sterility assurance

    GenoGenix is recalling L-Arginine HCl for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0025-2026·2025-10-15

    Infant bedtime drops recalled over potential yeast contamination in three lots

    M.O.M Enterprises is recalling 46,752 bottles of Organic Baby Bedtime Drops across three lots for potential yeast contamination.

    Product
    Organic BABY bedtime drops; sleep + immunity blend; Promotes restful sleep with natural herbs & supports immunity with elderberry & vitamin C; LIQUID DIETARY SUPPLEMENT; AGE 4 MONTHS+, NET WT. 2 OZ (60 ML)
    Category
    Food
    Distribution
    33 states