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.

8351–8375 of 88183

  • ModerateFDA (Devices)·Z-1587-2025·2025-04-23

    Medline Convenience Kits Rhinoplasty Pack Potential Weak Seals Recall

    Medline Industries is recalling Rhinoplasty Pack convenience kits (Model DYNJ84116A, Lot 24IBH580) due to potential open or weak seals on breather pouches used for packaging. Compromised packaging may affect sterility of the sterile kits.

    Product
    Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1602-2025·2025-04-23

    Sterile convenience kits recalled for potentially weak breather pouch seals

    Medline Industries is recalling sterile convenience kits due to potential open or weak seals on breather pouches used in packaging. Defective seals may compromise product sterility.

    Product
    Refer to RES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0716-2025·2025-04-23

    Golden Crop Candy Recalled for Undeclared Food Color Additives

    Blooming Import Inc. is recalling Golden Crop Candy (10 oz. wrapped candies) because it contains undeclared and unallowed food color additives: Blue 1, Red 40, and Acid Red 18.

    Product
    Golden Crop Candy (10 oz. (283g) wrapped candies)
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1567-2025·2025-04-23

    Welch Allyn DuraShock Aneroid Gauge Sets Reusable Blood Pressure Cuff Recall

    Baxter Healthcare Corporation is recalling certain Welch Allyn DuraShock Aneroid Gauge Sets with reusable blood pressure cuffs due to undeclared natural rubber band in the packaging. This poses a risk to individuals with rubber allergies.

    Product
    Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0715-2025·2025-04-23

    Tortilla Chips Recalled Due to Undeclared Yellow #5 Dye

    La Mexicana Tortilla Factory is recalling Tortilla Chip Green 4 cut products due to undeclared Yellow #5, an FDA-certified colorant that poses a risk to consumers with dye sensitivities or allergies.

    Product
    Tortilla Chip Green 4 cut packed 5lbs per bag; 6 bags per box
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0717-2025·2025-04-23

    Golden Crop Candy contains undeclared food color additives

    Blooming Import Inc. is recalling Golden Crop Candy (8 oz unwrapped) due to undeclared and unallowed color additives: Blue 1, Red 40, and Acid Red 18.

    Product
    Golden Crop Candy (8 oz. (227g) un-wrapped candies)
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0364-2025·2025-04-23

    Ciprofloxacin Ophthalmic Solution Recalled for Defective Container Cap

    Direct Rx is recalling Ciprofloxacin Ophthalmic Solution 0.3% because the cap spike may lodge in the bottle nozzle, preventing the medication from being dispensed.

    Product
    CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
    Category
    Drug
    Distribution
    5 states
  • LowFDA (Food)·F-0705-2025·2025-04-23

    Dried Seedless Plum Candy Recalled Due to Undeclared Cyclamates

    BaiWei ShanZhuang Dried Seedless Plum Candy is being recalled because it contains cyclamates, which are not declared on the label. The product was distributed across multiple states.

    Product
    BaiWei ShanZhuang, Dried Seedless Plum Candy, 9.16 oz. (260g), plastic bags, 30 bags per case.
    Category
    Food
    Distribution
    11 states
  • LowFDA (Food)·F-0703-2025·2025-04-23

    Farmer House Preserve Olive Strips recalled for undeclared cyclamates

    Lins Waha International Corp is recalling Farmer House Preserve Olive Strips due to the presence of cyclamates, which are not permitted food additives in the United States.

    Product
    Farmer House Preserve Olive Strips
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-1458-2025·2025-04-16

    Medline Heart Basin Procedure Kits with Aortic Cannula Recalled

    Medline medical procedure kits containing Medtronic Aortic Root Cannula are recalled due to potential excess material in the male luer connectors on the aortic cannula.

    Product
    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0360-2025·2025-04-16

    Proactiv Skin Smoothing Exfoliator recalled for benzene contamination

    Alchemee, LLC is recalling Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%) due to the presence of benzene, a known chemical contaminant.

    Product
    Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b) 0.33 OZ (9.45g), UPC 8 42944 10223 1; Distributed by Alchemee, LLC, Santa Monica, CA 90401,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1457-2025·2025-04-16

    Medline Medical Procedure Kits with Aortic Root Cannula Recalled

    Medline is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to potential excess material in the male lures on the cannula. The recall affects 468 units distributed across nine US states.

    Product
    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0357-2025·2025-04-16

    Haloperidol Decanoate Injection Recalled for Sterility Assurance Failure

    Somerset Therapeutics is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility resulting from bacterial contamination detected during media fill testing. The recall affects 23,960 vials distributed nationwide.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1543-2025·2025-04-16

    Stimulation RC Clinician Programmer Application Software Communication Issue

    The Stimulation RC Clinician Programmer Application (Model A71400) has a software issue that can permanently disable communication with certain implantable neurostimulators when a specific intraoperative programming sequence is used. Approximately 1,493 devices were distributed worldwide.

    Product
    Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0355-2025·2025-04-16

    Haloperidol Decanoate Injection Recalled for Sterility Assurance Defect

    Somerset Therapeutics is recalling 997 vials of Haloperidol Decanoate Injection 50mg/mL nationwide due to lack of assurance of sterility following bacterial contamination detected in a media fill validation test.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1459-2025·2025-04-16

    Medline Medical Procedure Kits with Medtronic Aortic Cannula Recalled

    Medline medical procedure kits containing a Medtronic Aortic Root Cannula are being recalled due to potential excess material in the male lures on the aortic cannula. The kits were distributed in nine US states.

    Product
    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0359-2025·2025-04-16

    Proactiv Emergency Blemish Relief recalled for benzene contamination

    Alchemee LLC is recalling Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%) due to the presence of benzene, a chemical contaminant. The recall affects approximately 38,237 bottles distributed nationwide.

    Product
    Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 10223 1, and also packaged as a twin pack UPC 8 42944 10241 5,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1512-2025·2025-04-16

    Hippo 072 Aspiration System recalled for distal tip detachment risk

    Qapel Medical Inc. is recalling the Hippo 072 Aspiration System and related components because the aspiration catheter distal tip may detach, potentially causing vessel rupture or vasospasm.

    Product
    Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95
    Category
    Medical Device
    Distribution
    29 states
  • SevereFDA (Drugs)·D-0354-2025·2025-04-16

    Methocarbamol Injection USP Recalled Due to Sterility Assurance Concerns

    Somerset Therapeutics is recalling Methocarbamol Injection USP (1,000 mg/10 mL vials) nationwide due to lack of assurance of sterility following bacterial contamination in media fill testing.

    Product
    METHOCARBAMOL — METHOCARBAMOL (METHOCARBAMOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2025·2025-04-16

    Haloperidol Decanoate Injection Recalled for Sterility Assurance Failure

    Somerset Therapeutics is recalling Haloperidol Decanoate Injection 50mg/mL vials nationwide due to lack of assurance of sterility from bacterial contamination detected in media fill testing.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0695-2025·2025-04-16

    Las Ollas Botana Mix snack recalled for undeclared allergens

    Kedake Inc is recalling Las Ollas Botana Mix snack (2lbs bags) due to undeclared sesame, soy, wheat, and food colorings (Yellow No. 5, Yellow No. 6, Red No. 6) that may pose a risk to consumers with allergies.

    Product
    Las Ollas Botana Mix snack, 2lbs, item #1516, # 1056, UPC# 880342001855
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0358-2025·2025-04-16

    Haloperidol Decanoate Injection Recalled Due to Sterility Concerns

    Somerset Therapeutics is recalling Haloperidol Decanoate Injection (100 mg/mL, 1 mL vials) due to lack of assurance of sterility caused by bacterial contamination detected in media fill testing.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1456-2025·2025-04-16

    Medline medical procedure kits with Medtronic Aortic Root Cannula recalled

    Medline Industries is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to a Class I defect. The kits were distributed to healthcare facilities in nine states.

    Product
    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN…
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0361-2025·2025-04-16

    Chlorpromazine Hydrochloride Tablets Recalled Due to Impurity

    Zydus Pharmaceuticals is recalling chlorpromazine hydrochloride 10 mg tablets due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. The recall affects 3,144 bottles distributed nationwide.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0702-2025·2025-04-16

    365 Whole Foods Market Frozen Macaroni and Cheese Recall

    365 Whole Foods Market Small Bites Macaroni & Cheese (8.5 oz) is being recalled because it contains undeclared eggs and pork, which pose a hazard to consumers with allergies.

    Product
    365 Whole Foods Market Small Bites Macaroni & Cheese. Net Wt 8.5 oz (240g) Keep Frozen. UPC 99482499709. Distributed by: Whole Foods Market, Austin, TX
    Category
    Food
    Distribution
    Distributed nationwide