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.

826–850 of 2741

  • LowFDA (Drugs)·D-0497-2019·2019-02-27

    Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotent Drug Concerns

    Advanced Pharma Inc. is recalling 12 bags of Oxytocin 10 Units Injectable Solution because the product may contain higher concentrations than labeled.

    Product
    Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0514-2019·2019-02-27

    Mometasone Furoate Cream Recalled for NDC Typographical Error

    ACP Nimble Buyer, Inc. is recalling Mometasone Furoate Cream due to a typographical error in the National Drug Code (NDC) on the label.

    Product
    Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0516-2019·2019-02-27

    Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures

    Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 5 mg, because the product failed to meet dissolution specifications.

    Product
    Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0491-2019·2019-02-20

    Valeant Recalls Diltiazem HCl Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 23,884 bottles of Diltiazem HCl CD capsules because they failed dissolution specifications, potentially affecting drug release.

    Product
    Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0483-2019·2019-02-20

    Akorn Recalls COSOPT Ophthalmic Solution Due to Stability Failures

    Akorn Inc. is recalling 30,794 bottles of COSOPT Ophthalmic Solution because the product failed stability specifications for opalescence.

    Product
    COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0822-2019·2019-02-20

    Luminex Recalls Verigene BC-GP Utility Kits Due to Labeling Error

    Luminex Corporation is recalling Verigene BC-GP Utility Kits because they were incorrectly labeled with Amplification Tray labels.

    Product
    Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0817-2019·2019-02-13

    La Canasta Flour Tortillas Recalled Due to Packaging Ink Contamination

    La Canasta Mexican Food Products is recalling specific lots of flour tortillas because packaging ink is contaminating the product.

    Product
    My Nanas Best Tasting Home Style-Estilo Casero Flour Tortillas Bakery Fresh. 24 oz (680g). Plastic bag
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-0794-2019·2019-02-13

    Ascension Radial Head Implant Recalled for Incorrect Instructions for Use

    Ascension Orthopedics is recalling specific Radial Head Implants because they were packaged with instructions for a different product.

    Product
    Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0792-2019·2019-02-13

    BD FACSLyric Flow Cytometer Recalled Due to Unsupported Operating System Configuration

    Becton, Dickinson and Company is recalling three BD FACSLyric flow cytometers because they were installed with an unsupported Windows 10 operating system configuration.

    Product
    BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0429-2019·2019-02-13

    Lupin Recalls Bimatoprost Ophthalmic Solution Due to Impurity Failures

    Lupin Pharmaceuticals is recalling Bimatoprost Ophthalmic Solution 0.03% because out-of-specification results were observed for individual and total impurities.

    Product
    Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0777-2019·2019-02-06

    Riverpoint Medical Recalls 18G Brachy Grids for Incorrect CE Labeling

    Riverpoint Medical is recalling 443 units of 18G Brachy Grids because they are labeled with a CE mark despite not being approved in the European Union.

    Product
    RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0391-2019·2019-01-30

    Sun Pharmaceutical Recalls Loperamide Hydrochloride Tablets Due to Labeling Error

    Sun Pharmaceutical Industries is recalling 5,040 cartons of Loperamide Hydrochloride 2 mg tablets because the carton front and side panels display conflicting caplet counts.

    Product
    LOPERAMIDE HYDROCHLORIDE — LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0379-2019·2019-01-23

    Bound Tree Medical Recalls Curaplex Epi Safe Kits Due to Labeling Errors

    Bound Tree Medical is recalling 747 Curaplex Epi Safe Kits because they are incorrectly labeled with an expiration date of May 2018 instead of May 2019, and the syringe component lacks 510(k) clearance.

    Product
    Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needle, 2 Alcohol Prep Pads,1 Adhesive Dressing, 1 Insert. Distributed by Sarnova, HC. LLC's family companies: Bound Tree Medical. LLC, Cardio Partners, Inc., Emergency Medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0700-2019·2019-01-16

    Boston Scientific Recalls IntellaTip MiFi Ablation Catheters in Japan

    Boston Scientific is recalling 1,282 IntellaTip MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.

    Product
    IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0699-2019·2019-01-16

    Boston Scientific Recalls Blazer Ablation Catheters Due to Resin Changes

    Boston Scientific is recalling 1,282 Blazer Open-Irrigated Ablation Catheters in Japan because resin sub-supplier changes caused material variations not reflected in internal documentation.

    Product
    Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0701-2019·2019-01-16

    Boston Scientific Recalls IntellaNav Ablation Catheters in Japan

    Boston Scientific is recalling IntellaNav MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.

    Product
    IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0690-2019·2019-01-09

    Ultradent Recalls Enamelast Fluoride Varnish Due to Off-Flavor Complaints

    Ultradent Products, Inc. is recalling specific lots of Enamelast 5% Sodium Fluoride Varnish because the product may have an unpleasant or off flavor.

    Product
    Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0691-2019·2019-01-09

    R&D Systems Recalls Human sTfR ELISA Kits Due to Incorrect Control Card

    R&D Systems is recalling 198 Human sTfR ELISA kits because they were packed with the wrong control data card number.

    Product
    Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0345-2019·2019-01-02

    Amerigen Recalls Temozolomide Capsules for Failed Dissolution Specifications

    Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 180 mg, due to failed dissolution specifications. The FDA classified this as a Class III recall.

    Product
    Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0655-2019·2018-12-26

    Nidek RT-5100 Refractor Recalled for Incomplete Lens Bonding

    Nidek Inc. is recalling 85 RT-5100 Refractors distributed in Florida because the lens bonding was incomplete.

    Product
    RT-5100 Refractor, a component of the Epic-5100 System.
    Category
    Medical Device
    Distribution
    1 state