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.

626–650 of 2766

  • LowFDA (Drugs)·D-0322-2020·2019-11-20

    Sato Pharmaceutical Recalls Subpotent Zentrip Meclizine Hydrochloride Strips

    Sato Pharmaceutical Inc. is voluntarily recalling Zentrip (meclizine Hydrochloride) 25 mg strips because the medication is subpotent. The recall covers 21,864 units distributed nationwide.

    Product
    Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0325-2020·2019-11-20

    Sato Pharmaceutical Recalls Subpotent Motion Sickness Strips Nationwide

    Sato Pharmaceutical Inc. is recalling 39,504 units of Motion Sickness Strips because the medication may contain less than the labeled amount of meclizine hydrochloride.

    Product
    Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0098-2020·2019-11-13

    La Samaritana Tomato Tortillas Recalled for Undeclared Red Dye

    Productos La Samaritana is recalling specific lots of tomato tortillas because they contain FD&C Red #40, which is not declared on the label.

    Product
    Selecto Wraps de Tomate, Tomato Wraps Econo Healthy Wraps, Soft Flour Tortillas, Tomate La Samaritana Tortillas, (Harina de Trigo) Tomate
    Category
    Food
    Distribution
    0 states
  • LowFDA (Food)·F-0099-2020·2019-11-13

    La Samaritana Tortillas Recalled for Failure to Declare FD&C Red #40

    Productos La Samaritana, Inc. is recalling specific lots of La Samaritana Tortillas because they contain FD&C Red #40, which was not declared on the label.

    Product
    La Samaritana Tortillas (Harina de Trigo) 8/12-12" Reg Rojo
    Category
    Food
    Distribution
    0 states
  • LowFDA (Drugs)·D-0303-2020·2019-11-13

    Sato Pharmaceutical Recalls Sankaijo Botanical Laxative Tablets

    Sato Pharmaceutical Inc. is recalling Sankaijo Botanical Laxative tablets because the sennosides content is lower than the labeled claim.

    Product
    SANKAIJO — SANKAIJO (DOCUSATE SODIUM, SENNOSIDES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0304-2020·2019-11-13

    Lupin Recalls Cephalexin Oral Suspension Due to Foreign Substance

    Lupin Pharmaceuticals is recalling Cephalexin for Oral Suspension bottles because a dead ant was identified as a foreign substance.

    Product
    Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0297-2020·2019-11-13

    Helena Laboratories Recalls SPIFE Alkaline Hemoglobin Kits Due to Incorrect Instructions

    Helena Laboratories is recalling 899 SPIFE Alkaline Hemoglobin Kits because they contain incorrect instruction inserts referencing unavailable electrode parameters.

    Product
    SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
    Category
    Medical Device
    Distribution
    22 states
  • LowFDA (Food)·F-0125-2020·2019-11-13

    Dr. Pepper 24-Pack Cans Recalled for Undeclared Aspartame

    Epic Enterprises is recalling Dr. Pepper 24-pack cans in Connecticut, Maine, and Rhode Island because they contain undeclared aspartame.

    Product
    Dr. Pepper 24 pack of 12 FL OZ Cans (288 FL OZ) in cardboard cases: Produced under the authority of Dr. Pepper/Seven Up, Inc., 5301 Legacy Drive, Plano, TX 75024; Best Before: JUN 29 20; Case UPC: 078000082104; Can UPC: 07831504
    Category
    Food
    Distribution
    3 states
  • 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-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 (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-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-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 (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 (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-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 (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-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 (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 (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