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.

8426–8450 of 88183

  • ModerateFDA (Devices)·Z-1541-2025·2025-04-16

    Stryker Blueprint Mixed Reality Instrument Kit Recall for Total Shoulder Arthroplasty

    Stryker is recalling the Blueprint Mixed Reality Instrument Kit for Total Shoulder Arthroplasty due to an elevated rate of complaints about software and instrumentation malfunctions that prevent the system from meeting its intended use.

    Product
    stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1539-2025·2025-04-16

    Stryker Blueprint Mixed Reality Glenoid Box Lid system functionality issues

    Stryker is recalling the Blueprint Mixed Reality Glenoid Box Lid and related instrumentation kits due to elevated complaint rates. The product experiences software and instrumentation issues that prevent it from meeting its intended use.

    Product
    stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0344-2025·2025-04-16

    Clindamycin Hydrochloride Capsules Recalled for Manufacturing Practice Deviations

    Glenmark Pharmaceuticals Inc. USA is recalling Clindamycin Hydrochloride Capsules, USP 300mg due to CGMP deviations. The product has been distributed nationwide.

    Product
    CLINDAMYCIN HYDROCHLORIDE — CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1531-2025·2025-04-16

    Wayson Hydrocolloid Bandages recalled due to sterility concerns

    Medline Industries is recalling Wayson Hydrocolloid Bandages because the sterility of the devices may be compromised. Affected products include multiple models distributed nationwide and internationally.

    Product
    Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2; 3) MJ BNDG HYDROCOLLOID FINGER TOE 8CT, Model Number: MJ76126V2; 4) WALMART,BANDAGE,HYDROCOLLOID,HEEL,6CT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0339-2025·2025-04-16

    Rosuvastatin Calcium Tablets Recalled Nationwide Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Rosuvastatin Calcium 40mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lot numbers expiring February through June 2026.

    Product
    ROSUVASTATIN CALCIUM — ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0334-2025·2025-04-16

    Teriflunomide Tablets 14mg Recalled for CGMP Manufacturing Deviations

    Glenmark Pharmaceuticals Inc. is voluntarily recalling Teriflunomide 14mg tablets (Lot #17232462, expiring Nov-25) distributed nationwide due to current good manufacturing practice (CGMP) deviations discovered during production.

    Product
    TERIFLUNOMIDE — TERIFLUNOMIDE (TERIFLUNOMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1542-2025·2025-04-16

    Stryker HoloBlueprint Application Medical Device Software Functionality Recall

    Stryker is recalling the HoloBlueprint Application (Catalog Number MRUE001) for Total Shoulder Arthroplasty due to software and instrumentation malfunctions that prevent the system from meeting its intended use.

    Product
    stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1551-2025·2025-04-16

    Siemens Atellica CH Revised C Reactive Protein Assay Software Flagging Issue

    Siemens Healthcare Diagnostics is recalling the Atellica CH Revised C Reactive Protein assay due to incorrect software flagging that may produce erroneous results.

    Product
    Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1540-2025·2025-04-16

    Stryker Blueprint Mixed Reality Depth Stop Pin Total Shoulder Arthroplasty Recalled

    Stryker is recalling the Blueprint Mixed Reality Depth Stop Pin (Catalog Number MRUE206) due to elevated complaints of software and instrumentation malfunctions that prevent intended use. The recall affects 474 units distributed in multiple US states and internationally.

    Product
    stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0328-2025·2025-04-16

    Metformin Hydrochloride Extended-Release Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is recalling Metformin Hydrochloride Extended-Release Tablets 1000mg due to manufacturing practice deviations. The recall affects 90-count bottles distributed nationwide and is voluntary.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0332-2025·2025-04-16

    Saxagliptin 5mg Tablets Recalled for Manufacturing Practice Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Saxagliptin 5mg tablets nationwide due to CGMP deviations. Affected lot numbers are 17232460 and 17241194.

    Product
    SAXAGLIPTIN — SAXAGLIPTIN (SAXAGLIPTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0350-2025·2025-04-16

    Pravastatin Sodium Tablets Recalled Due to Manufacturing Practice Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Pravastatin Sodium 80mg tablets due to Current Good Manufacturing Practice deviations. The nationwide recall affects specific lot numbers and remains ongoing.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0323-2025·2025-04-16

    Glenmark Rufinamide Tablets Recalled for Manufacturing Process Deviations

    Glenmark Pharmaceuticals is recalling Rufinamide 200mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects certain lot numbers with July 2025 expiration dates.

    Product
    RUFINAMIDE — RUFINAMIDE (RUFINAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0326-2025·2025-04-16

    Fluphenazine Hydrochloride Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fluphenazine Hydrochloride Tablets, 10mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects one lot distributed nationwide.

    Product
    FLUPHENAZINE HYDROCHLORIDE — FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0697-2025·2025-04-16

    Cabot Creamery Extra Creamy Premium Butter Recalled for Coliform Contamination

    Cabot Creamery 8oz Extra Creamy Premium Sea Salted Butter is recalled due to contamination with elevated levels of coliform. The affected product was distributed in Vermont, New York, Pennsylvania, Maine, Connecticut, New Hampshire, and Arkansas.

    Product
    Cabot Creamery 8oz Extra Creamy Premium Butter, Sea Salted. Packaged as (2) 4oz sticks in cardboard shells; UPC: 0 78354 62038 0
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0338-2025·2025-04-16

    Prochlorperazine Maleate Tablets Recalled for Manufacturing Process Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Prochlorperazine Maleate 10mg tablets (NDC# 68462-890-01) distributed nationwide due to manufacturing process deviations. No illnesses or injuries have been reported.

    Product
    Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0330-2025·2025-04-16

    Glenmark Lacosamide 100mg Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals is recalling Lacosamide 100mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated this voluntary recall on March 13, 2025.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1535-2025·2025-04-16

    Stryker Blueprint Mixed Reality Glenoid Digitizer Software Functioning Issues

    Stryker is recalling the Blueprint Mixed Reality Glenoid Digitizer due to elevated complaint rates affecting system functionality. The device cannot reliably meet its intended use in total shoulder arthroplasty procedures.

    Product
    stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0345-2025·2025-04-16

    FDA Recalls Saxagliptin Tablets Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Saxagliptin 2.5mg tablets nationwide due to manufacturing quality issues. The firm initiated this voluntary recall on March 13, 2025.

    Product
    SAXAGLIPTIN — SAXAGLIPTIN (SAXAGLIPTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0320-2025·2025-04-16

    Gabapentin 600mg Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc. is voluntarily recalling Gabapentin 600mg tablets (500-count bottles) nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0322-2025·2025-04-16

    Frovatriptan Succinate tablets recalled due to manufacturing deviations

    Glenmark Pharmaceuticals Inc., USA is recalling Frovatriptan Succinate 2.5mg tablets nationwide due to current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this as a Class II recall.

    Product
    FROVATRIPTAN SUCCINATE — FROVATRIPTAN SUCCINATE (FROVATRIPTAN SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0333-2025·2025-04-16

    Solifenacin Succinate Tablets Recalled Due to Manufacturing Deviations

    Glenmark Pharmaceuticals Inc., USA is recalling Solifenacin Succinate 5mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and affects 30-count and 90-count bottles distributed across the U.S.

    Product
    SOLIFENACIN SUCCINATE — SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0311-2025·2025-04-16

    Gabapentin Capsules Recalled for Cross Contamination

    Sun Pharmaceutical Industries is recalling Gabapentin Capsules, USP 300 mg, due to cross contamination. The recall affects approximately 12,876 bottles distributed nationwide.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0312-2025·2025-04-16

    Gabapentin Capsules 400 mg Recalled for Cross Contamination

    Sun Pharmaceutical Industries Inc. is recalling Gabapentin Capsules 400 mg due to cross contamination. The recall affects 852 bottles distributed nationwide.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide