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.

6676–6700 of 21595

  • ModerateFDA (Drugs)·D-1421-2020·2020-08-05

    MasterPharm Recalls Estriol 8 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Estriol 8 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1433-2020·2020-08-05

    MasterPharm Recalls Progesterone Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling 600 capsules of Progesterone Modified Release 100 mg due to a lack of processing controls that ensures conformity to specifications.

    Product
    Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1445-2020·2020-08-05

    Sun Pharmaceutical Recalls Clonazepam Tablets Due to Cross-Contamination

    Sun Pharmaceutical is recalling Clonazepam Orally Disintegrating Tablets because routine stability testing detected cross-contamination with clozapine.

    Product
    Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2698-2020·2020-08-05

    Synthes Recalls MatrixNEURO Screws Due to Incorrect Body Clip Labeling

    Synthes, Inc. is recalling 104 units of MatrixNEURO 5mm screws because the body clip is etched with '4', incorrectly indicating a 4mm screw, despite correct outer packaging.

    Product
    MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1426-2020·2020-08-05

    MasterPharm Recalls Minoxidil/Biotin/Spironolactone Capsules Due to Processing Controls

    MasterPharm LLC is recalling Minoxidil/Biotin/Spironolactone capsules nationwide due to a lack of processing controls and assurance of conformity to specifications.

    Product
    Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1039-2020·2020-08-05

    Built Brands Recalls Peanut Butter Chocolate Protein Bars for Mold Risk

    Built Brands LLC is recalling 242,400 peanut butter chocolate protein bars because they may be moldy before the expiration date.

    Product
    Peanut Butter Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2693-2020·2020-07-29

    Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty

    Medtronic is recalling Accurian RF Ablation Cannulas because the probes catch on a lip inside the hub, causing insertion difficulty.

    Product
    Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2690-2020·2020-07-29

    Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty

    Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches on a lip inside the hub, causing insertion difficulty.

    Product
    Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2695-2020·2020-07-29

    Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty

    Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches on a lip inside the hub, causing insertion difficulty.

    Product
    Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2691-2020·2020-07-29

    Medtronic Recalls Accurian RF Ablation Cannulas Due to Insertion Difficulty

    Medtronic is recalling Accurian RF Ablation Cannulas because the probes may catch on a lip inside the hub, causing insertion difficulty.

    Product
    Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2694-2020·2020-07-29

    Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty

    Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches on a lip inside the hub, causing insertion difficulty.

    Product
    Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1416-2020·2020-07-29

    Walker Emulsions Hand Sanitizer Recalled for Unapproved Excipient

    Walker Emulsions Inc. is recalling 1-gallon bottles of 60% hand sanitizer because it contains an unapproved excipient, DA-2I Ethanol.

    Product
    Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1417-2020·2020-07-29

    Walker Hand Sanitizer Recalled for Unapproved Excipient

    Walker Emulsions Inc. is recalling Walker Hand Sanitizer because it contains DA-2I Ethanol, an excipient not approved for use in hand sanitizers.

    Product
    Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2692-2020·2020-07-29

    Medtronic Accurian RF Ablation Cannula Recall for Insertion Difficulty

    Medtronic is recalling Accurian RF Ablation Cannulas because the probe may catch on a lip inside the hub, causing insertion difficulty.

    Product
    Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2684-2020·2020-07-29

    Nuvasive NVM5 EMG Module Recalled for Incorrect Component

    NuVasive Inc is recalling 23 NVM5 EMG Modules because they contain an incorrect SSEP harness instead of the correct NVM5 Harness, potentially delaying spinal surgery monitoring.

    Product
    Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2685-2020·2020-07-29

    Smith & Nephew Recalls TRIGEN Intramedullary Nail Sleeves Due to Sterilization Error

    Smith & Nephew is recalling 12 TRIGEN intramedullary nail sleeves because a manufacturing error led to improper re-sterilization of the polyethylene material.

    Product
    TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2672-2020·2020-07-29

    U&I Corp Recalls ANAX 5.5 Poly-Reduction Screws Due to Incorrect Laser Etching

    U&I Corp. is recalling six ANAX 5.5 Poly-Reduction Screws because they were laser etched with the wrong size (6.0x45 instead of 6.0x50).

    Product
    ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2639-2020·2020-07-22

    Neocis Gen 2 Anterior Chairside Splint Recalled for Mislabeled Packaging

    Neocis Inc. is recalling 50 units of Gen 2 Anterior Chairside Splints due to potential mislabeling. The affected products are distributed nationwide.

    Product
    DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1388-2020·2020-07-22

    Akorn Recalls Proparacaine Hydrochloride Ophthalmic Solution Due to Chemical Contamination

    Akorn, Inc. is recalling Proparacaine Hydrochloride Ophthalmic Solution, 0.5%, due to chemical contamination from equipment cleaning residue.

    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2590-2020·2020-07-22

    DJO Nylatex Wraps Recalled for Missing Latex Warning Labels

    DJO, LLC is recalling Nylatex wraps used with Intelect and V-Sonic devices because they lack appropriate latex warning labels.

    Product
    This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2637-2020·2020-07-22

    Neocis Dental Chairside Splints Recalled for Potential Mislabeling

    Neocis Inc. is recalling specific dental chairside splints because they may be mislabeled. The recall covers 70 units distributed nationwide.

    Product
    DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2591-2020·2020-07-22

    Shimadzu Recalls Three Trinias DAP Meters for Tolerance Issues

    Shimadzu Medical Systems is recalling three Trinias DAP Meters because they were found to be outside of tolerance. The devices are used in interventional procedures.

    Product
    Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1045-2020·2020-07-22

    Lamb Weston Recalls WinCo Tater Bites Due to Foreign Material Contamination

    Lamb Weston is recalling WinCo Foods Tater Bites Shaped, Shredded Potatoes because the product may contain foreign material. The recall covers 558 cases distributed in California, Oregon, and Washington.

    Product
    WinCo Foods Tater Bites Shaped, Shredded Potatoes, frozen product. Retail 32 oz. poly bag has UPC 0 70552 30303 4. The master case contains 12/32 oz. bags (net wt. 24 lbs.), identified as WinCo Foods Tater Bites WN420, 1 00 70552 30303 1. The 32 oz. retail package label is
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1389-2020·2020-07-22

    Keryx Recalls Auryxia Tablets Due to Manufacturing Process Deviations

    Keryx Biopharmaceuticals is recalling 59,820 bottles of Auryxia (ferric citrate) tablets because they were not manufactured in conformance with the FDA-approved process.

    Product
    AURYXIA — AURYXIA (FERRIC CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide