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.

6626–6650 of 21595

  • ModerateFDA (Food)·F-1157-2020·2020-08-19

    Uncommon Canning Recalls Strongbrew CBD Cold Brew Coffee for Storage Issues

    Uncommon Canning LLC is recalling 5,754 cans of Strongbrew CBD Infused Cold Brew Coffee because the product was not stored under refrigeration prior to shipment.

    Product
    Strongbrew CBD Infused Cold Brew Coffee, 12oz can, KEEP REFRIGERATED, UPC: 71203869615
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2801-2020·2020-08-19

    Arrow Single Shot Epidural Anesthesia Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling specific lots of Single Shot Epidural Anesthesia Kits because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.

    Product
    Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2751-2020·2020-08-12

    Randox Lipase Assay Reagent Recalled for Imprecision in Quality Control and Patient Samples

    Randox Laboratories is recalling specific batches of Lipase Colorimetric Reagent due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2753-2020·2020-08-12

    Randox Lipase Assay Substrate Recalled for Imprecision in Quality Control

    Randox Laboratories is recalling specific batches of Lipase R2 Substrate due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1488-2020·2020-08-12

    Vilvet Pharmaceuticals Recalls VILEVEV MB Urinary Antiseptic Due to cGMP Deviations

    Vilvet Pharmaceuticals is voluntarily recalling 1,716 bottles of VILEVEV MB Urinary Antiseptic due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate), Rx Only, 90 Tablets per Bottle, Manufactured for: Vilvet Pharmaceuticals, Inc., Chester Springs, PA 19425
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1487-2020·2020-08-12

    Vilvet Pharmaceuticals Recalls VILAMIT MB Due to cGMP Deviations

    Vilvet Pharmaceuticals is recalling 11,640 bottles of VILAMIT MB capsules due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and nationwide.

    Product
    VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate), Rx Only, 100 Capsules per Bottle, Manufactured for: Vilvet Pharmaceuticals Inc., Chester Springs, PA 18425, NDC 71186-002-35.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2749-2020·2020-08-12

    Teleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Compromise

    Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.

    Product
    Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2744-2020·2020-08-12

    Sutter Swyng Non-Stick Bipolar Forceps Recalled for Incorrect Package Insert Labeling

    Sutter Medizintechnik GmbH is recalling 1,337 units of Sutter Swyng non-stick bipolar forceps because the package insert incorrectly displays the Ethylene Oxide sterilization symbol instead of the irradiation symbol.

    Product
    Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2746-2020·2020-08-12

    Smith & Nephew Recalls SUTUREFIX ULTRA Suture Due to Packaging Error

    Smith & Nephew is recalling 868 units of SUTUREFIX ULTRA Suture because a packaging error caused an XL drill to be included instead of the correct S drill.

    Product
    SUTUREFIX ULTRA Suture, Product number 72203855
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2747-2020·2020-08-12

    Siemens DCA Vantage Barcode Scanner Recalled for Data Integrity Issues

    Siemens Healthcare is recalling 1,800 DCA Vantage Handheld Barcode Scanners because they may fail to verify check digits or incorrectly process barcodes, potentially leading to data errors.

    Product
    DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2752-2020·2020-08-12

    Randox Lipase Assay Buffer Recalled for Imprecision in Quality Control

    Randox Laboratories is recalling specific batches of Lipase Colorimetric R1 Buffer due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1425-2020·2020-08-05

    MasterPharm Recalls Minoxidil/Biotin Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Minoxidil/Biotin 1.25mg/5mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2709-2020·2020-08-05

    TTDEYE Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Diamonds Starlight colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1440-2020·2020-08-05

    MasterPharm Recalls Tadalafil 7 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Tadalafil 7 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Tadalafil 7 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2739-2020·2020-08-05

    Synthes Recalls MatrixMIDFACE Screws Due to Incorrect Size Marking

    Synthes Produktions GmbH is recalling 41 units of MatrixMIDFACE Screws because the body clip was etched with the wrong size number.

    Product
    MatrixMIDFACE 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-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-1436-2020·2020-08-05

    MasterPharm Recalls Tadalafil 12 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Tadalafil 12 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Tadalafil 12 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-1430-2020·2020-08-05

    MasterPharm Recalls Progesterone Tablets Due to Processing Control Deficiencies

    MasterPharm LLC is recalling specific lots of Progesterone 150 mg tablets because they lack assurance of conformity to specifications.

    Product
    Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1437-2020·2020-08-05

    MasterPharm Recalls Tadalafil 18 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Tadalafil 18 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2702-2020·2020-08-05

    Smith & Nephew T-F1X0 RCG Drill Pac Recalled for Missing Sleeve

    Smith & Nephew is recalling T-F1X0 RCG Drill Pacs because some sterile packages contain only one sleeve instead of two, preventing the device from performing as intended for the second bone tunnel.

    Product
    Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1423-2020·2020-08-05

    MasterPharm Recalls Formula 82F Minoxidil Tretinoin Fluocinolone Acetonide Finasteride

    MasterPharm LLC is recalling 462 units of Formula 82F topical solution due to a lack of processing controls that compromised product specifications.

    Product
    Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15 mL) bottle MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1419-2020·2020-08-05

    MasterPharm Recalls D-Biotin 300 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling D-Biotin 300 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    D-Biotin 300 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-1443-2020·2020-08-05

    MasterPharm Recalls Yohimbine HCL Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Yohimbine HCL 5.4mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Yohimbine HCL 5.4mg 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-1441-2020·2020-08-05

    MasterPharm Recalls Testosterone/Anastrozole Pellets Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Testosterone/Anastrozole Pellets 100/6 mg due to a lack of processing controls that ensures conformity to specifications.

    Product
    Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419 (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1034-2020·2020-08-05

    Built Brands Recalls Banana Nut Bread Chocolate Covered Protein Bars

    Built Brands LLC is recalling 333,420 Banana Nut Bread Chocolate covered protein bars because they may be moldy prior to the end of the stated shelf life.

    Product
    Banana Nut Bread 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