The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

651–675 of 2738

  • LowFDA (Drugs)·D-0167-2020·2019-11-06

    Arbor Pharmaceuticals Recalls Testosterone Cypionate Injection Due to Labeling Error

    Arbor Pharmaceuticals is recalling specific lots of Testosterone Cypionate Injection because shipper cartons were mislabeled, potentially causing confusion with different vial sizes.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0161-2020·2019-11-06

    Sandoz Recalls Bimatoprost Ophthalmic Solution Due to Missing Package Insert

    Sandoz Inc is recalling Bimatoprost Ophthalmic Solution 0.03% because the package insert is incorrect or missing. The recall covers 346,929 bottles distributed nationwide.

    Product
    BIMATOPROST — BIMATOPROST (BIMATOPROST)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0079-2020·2019-11-06

    Jack Daniels Tennessee Whiskey Cake Recalled for Potential Mold

    The Great Spirits Baking Company is recalling Jack Daniels Tennessee Whiskey Cake due to potential mold growth before the best-by date.

    Product
    Jack Daniels Tennessee Whiskey Cake - Chocolate - Net Wt 8 OZ (227 g), UPC: 854621004349
    Category
    Food
    Distribution
    6 states
  • LowFDA (Devices)·Z-0231-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0225-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0230-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0154-2020·2019-11-06

    Nephron Recalls Succinylcholine Chloride Injection Due to Incorrect Labeling

    Nephron Pharmaceuticals is recalling 19,390 syringes of Succinylcholine Chloride Injection because of incorrect or missing lot and expiration dates.

    Product
    PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0166-2020·2019-11-06

    AuroMedics Recalls Ranitidine Tablets Due to Empty Bottles

    AuroMedics Pharma LLC is recalling one lot of Ranitidine Tablets USP, 150 mg, because some bottles were found to be empty.

    Product
    Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0162-2020·2019-11-06

    Sandoz Recalls Neomycin and Polymyxin B Ophthalmic Suspension for Labeling Error

    Sandoz Inc. is recalling 346,929 bottles of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension due to incorrect or missing package inserts.

    Product
    NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE — NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0061-2020·2019-10-30

    Source Naturals Brain Charge Recalled for Labeling Errors

    Threshold Enterprises Ltd is recalling Source Naturals Brain Charge dietary supplements because the label claims for two ingredients were lower than the actual product formulation.

    Product
    Source Naturals Dietary Supplement Brain Charge Advanced Cognitive Support 30 tablets, 60 tablets Manufactured for: Source Natural, Inc. PO Box 2118 Santa Cruz, CA 95062 Item Code: SN2613, SN2614 Item UPC: 021078026136, 021078026143
    Category
    Food
    Distribution
    30 states
  • LowFDA (Devices)·Z-0162-2020·2019-10-30

    Xintec OptiLITE Laser Fiber Assembly Recall Due to Programming Error

    Xintec Corp is recalling 45 OptiLITE laser fiber assemblies because they were programmed incorrectly. The devices will produce an error and prevent laser use.

    Product
    OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0192-2020·2019-10-30

    Arrow AGB+ Multi-Lumen CVC Kit Recalled for Incorrect Lidstock Labeling

    Arrow International Inc is recalling 745 units of the AGB+ Multi-Lumen CVC Kit because the lidstock label incorrectly lists the product code and catheter length.

    Product
    Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0152-2020·2019-10-23

    Roche Diagnostics Recalls cobas Integra Albumin Gen.2 Test Kits

    Roche Diagnostics is recalling cobas Integra Albumin Gen.2 test kits due to low quality control recovery and invalid calibration.

    Product
    Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0142-2020·2019-10-23

    KVK-Tech Recalls Methylphenidate Hydrochloride Oral Solution Due to Foreign Particles

    KVK-Tech is recalling 384 bottles of Methylphenidate Hydrochloride Oral Solution because of the presence of fiber particles.

    Product
    Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0153-2020·2019-10-23

    Roche Cobas c Bilirubin Total Gen.3 Recalled for Quality Control Issues

    Roche Diagnostics is recalling 2,304 units of the Cobas c Bilirubin Total Gen.3 in vitro test due to low quality control recovery and invalid calibration.

    Product
    Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0131-2020·2019-10-16

    Teva Recalls Matzim LA Tablets Due to GMP Deviation

    Teva Pharmaceuticals USA is recalling 5,849 bottles of Matzim LA (Diltiazem Hydrochloride) 240 mg tablets because the lot was not intended for commercial distribution.

    Product
    MATZIM LA — MATZIM LA (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-0138-2020·2019-10-16

    Guerbet Recalls Sodium Chloride Syringes Due to RFID Formatting Error

    Guerbet LLC is recalling 3,140 prefilled sodium chloride syringes because an RFID formatting error prevents the Optivantage injector from administering the product.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2253-2019·2019-10-09

    Frito-Lay Recalls Tostitos Salsa Con Queso Due to Glass Jar Defect

    Frito-Lay is recalling 95,412 jars of Tostitos Medium Salsa Con Queso because a defect in the glass jar packaging could affect the vacuum seal and cause potential spoilage.

    Product
    Tostitos Medium Salsa Con Queso 23 oz. packaged in a clear glass jar UPC 2840006740
    Category
    Food
    Distribution
    0 states
  • LowFDA (Food)·F-2254-2019·2019-10-09

    Frito-Lay Recalls Tostitos Queso Dip Due to Glass Jar Defect

    Frito-Lay is recalling Tostitos Medium Queso Blanco Dip because a defect in the glass jar packaging could affect the vacuum seal and cause potential spoilage.

    Product
    Tostitos Medium Queso Blanco Dip 23 oz. packaged in clear glass jar UPC 28400 66872
    Category
    Food
    Distribution
    0 states
  • LowFDA (Drugs)·D-0066-2020·2019-10-09

    Labetalol HCl syringes are recalled due to lack of sterility assurance

    The FDA is recalling 6,405 units of Labetalol HCl single-dose syringes because there was insufficient assurance of sterility during production. No illnesses or injuries have been reported.

    Product
    Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2255-2019·2019-10-09

    Frito-Lay Recalls Tostitos Salsa Due to Glass Jar Packaging Defect

    Frito-Lay is recalling Tostitos Medium Chunky Salsa in glass jars because a packaging defect may affect the vacuum seal and cause spoilage.

    Product
    Tostitos Medium Chunky Salsa 24 oz. packaged in clear glass jar UPC 28400 03282
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-0029-2020·2019-10-09

    CooperSurgical Embryology Heated Plate Recall Due to Touchpad Malfunction

    CooperSurgical is recalling 60 Embryology Heated Plates within the RI Witness system because the touchpad may not work properly after cleaning.

    Product
    Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2764-2019·2019-10-09

    ELITech Viva-ProE Systems Recalled for Software Malfunction

    ELITech Group B.V. is recalling 89 Viva-ProE Systems because a software malfunction causes the devices to become inoperable.

    Product
    Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2555-2019·2019-10-02

    Arrow International Recalls Central Venous Access Kits Due to Incorrect Banner Card

    Arrow International Inc is recalling 520 units of ARROW+gard Blue PSI Kit Cath-Gard central venous access devices because they may contain the incorrect banner card.

    Product
    8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue¿ permits venous access and catheter introduction to the central circulation. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide