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.

851–875 of 2741

  • LowFDA (Devices)·Z-0642-2019·2018-12-26

    Zimmer Biomet Compress System Surgical Technique Correction Recall

    Zimmer Biomet is correcting the surgical technique for the Compress System to update selection criteria for anti-rotation pin placement.

    Product
    Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0348-2019·2018-12-26

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Failures

    VistaPharm is recalling Nystatin Oral Suspension because it failed impurity specifications. The affected product is distributed nationwide and in Puerto Rico.

    Product
    NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0342-2019·2018-12-26

    CBI Laboratories Recalls Subpotent Options Rx Sunscreen Tubes

    CBI Laboratories is recalling 2,055 tubes of Options Rx Anti-Oxidant Oil-Free Sunscreen because the product failed to meet specifications for active ingredient percentages.

    Product
    Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort Worth, TX 76155
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0601-2019·2018-12-19

    Tosoh Recalls Hemoglobin A1c Control Material Due to Potential Degradation

    Tosoh Bioscience is recalling Hemoglobin A1c Control material due to potential degradation that may cause testing delays.

    Product
    Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0529-2019·2018-12-12

    Helena Laboratories Recalls Gel Alkaline Phosphatase Isoenzyme Control Kits

    Helena Laboratories is recalling 43 Gel Alkaline Phosphatase Isoenzyme Control Kits due to customer complaints of lower enzyme activity.

    Product
    Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0526-2019·2018-12-12

    Neomed NeoConnect Enteral Extension Sets Recalled for Incorrect Expiration Date

    Neomed Inc is recalling NeoConnect Enteral Extension Sets because the sterile pouch labels display an incorrect expiration date of 2016-11-19 instead of 2019-11-09.

    Product
    NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate…
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Drugs)·D-0289-2019·2018-12-12

    Aurobindo Recalls Amlodipine and Olmesartan Medoxomil Tablets Due to Discoloration

    Aurobindo Pharma USA Inc. is recalling Amlodipine and Olmesartan Medoxomil tablets because they were found to be pink instead of the expected cream color.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0516-2019·2018-12-05

    Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance

    Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to confirmed foreign substance contamination.

    Product
    Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0511-2019·2018-12-05

    Numed Multi-Track Angiographic Catheter Recall for Missing Instructions

    Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters because Instructions for Use booklets were not included on the outer pouch.

    Product
    Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0284-2019·2018-12-05

    RemedyRepack Recalls Nitrofurantoin Capsules Due to Cross-Contamination

    RemedyRepack Inc. is recalling specific lots of Nitrofurantoin Monohydrate/Macrocrystals capsules due to potential cross-contamination with unrelated ingredients.

    Product
    Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC 00185-0122-01Repackaged NDC 70518-1087-00, 14 capsules in HDPE 60 cc bottles in cardboard…
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Food)·F-0671-2019·2018-12-05

    Red Bull Energy Drink Recalled for Excess Ingredient Levels

    Red Bull North America Inc. is recalling specific batches of 8.4 fl. oz. Red Bull Energy Drink because they contain three times the specified level of primary ingredients.

    Product
    Red Bull Energy Drink, 8.4 Fl. oz. (250 mL) Ingredient: Carbonated water, Sucrose, Glucose, Citric Acid, Taurine, Sodium Bicarbonate, Magnesium, Carbonate Caffeine, Nicainamide, Calcium Pantothenate, Pyridoxine HCL, Vitamin B12, Natural and artificial Flavors, colors.…
    Category
    Food
    Distribution
    5 states
  • LowFDA (Devices)·Z-0508-2019·2018-12-05

    WOM World of Medicine Recalls PNEUMOCLEAR Heated High-Flow Tube Sets

    WOM World of Medicine AG is recalling PNEUMOCLEAR Heated High-Flow Tube Sets because packaging may be damaged by the tube set prongs.

    Product
    PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0286-2019·2018-11-21

    Takeda Recalls Amitiza Capsules Due to Elevated Impurity Levels

    Takeda is recalling specific lots of Amitiza (lubiprostone) capsules because stability testing found elevated levels of a known impurity.

    Product
    AMITIZA — AMITIZA (LUBIPROSTONE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0414-2019·2018-11-21

    Collagen Matrix Recalls BioMend Extend Due to Potential Packaging Error

    Collagen Matrix, Inc. is recalling 569 units of BioMend Extend synthetic bone grafting material because the product may have been packaged in the wrong box.

    Product
    BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0240-2019·2018-11-21

    Right Value Drug Stores Recalls Progesterone SR 100 mg Capsules for Misbranding

    Right Value Drug Stores, Inc. is recalling 6,580 capsules of Progesterone SR 100 mg due to misbranding. The affected product was distributed in California.

    Product
    Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0104-55
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0243-2019·2018-11-21

    Right Value Drug Stores Recalls Tadalafil SR 12 mg Capsules for Misbranding

    Right Value Drug Stores, Inc. is recalling Tadalafil SR 12 mg capsules distributed in California due to labeling misbranding.

    Product
    Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376 NDC 99999-9969-51
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0279-2019·2018-11-21

    Breckenridge Recalls Megestrol Acetate Oral Suspension for Stability Failures

    Breckenridge Pharmaceutical is recalling Megestrol Acetate Oral Suspension due to out-of-specification particle size results during stability testing.

    Product
    Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0262-2019·2018-11-21

    Sandoz Recalls Nitrofurantoin Capsules Due to Cross-Contamination

    Sandoz Inc. is recalling specific lots of Nitrofurantoin Capsules 100 mg due to cross-contamination with other products.

    Product
    Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0425-2019·2018-11-21

    Kroger Recalls Simple Truth Organic Red Quinoa for Pesticide Non-Compliance

    The Kroger Co is recalling Simple Truth Organic Red Quinoa because the product was not in compliance for pesticide exclusion.

    Product
    simple truth organic Red Quinoa Ingredients: organic red quinoa Distributed by The Kroger Co, Cincinnati, OH UPC1111086333 NET WT 16 oz (1 lb)
    Category
    Food
    Distribution
    7 states
  • LowFDA (Drugs)·D-0241-2019·2018-11-21

    Right Value Drug Stores Recalls Progesterone SR 200 mg Capsules for Misbranding

    Right Value Drug Stores, Inc. is recalling specific lots of Progesterone SR 200 mg Capsules due to misbranding. The affected products were distributed in California.

    Product
    Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0018-74
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0242-2019·2018-11-21

    Right Value Drug Stores Recalls Tadalafil SR 7 mg Capsules for Misbranding

    Right Value Drug Stores, Inc. is recalling Tadalafil SR 7 mg capsules due to misbranding. The affected lots were distributed in California.

    Product
    Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054. NDC 99999-9970-88
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0245-2019·2018-11-21

    RemedyRepack Recalls Metoprolol Tartrate Injection Due to pH Failures

    RemedyRepack Inc. is recalling specific lots of Metoprolol Tartrate Injection because stability testing showed high pH levels that failed specifications.

    Product
    Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
    Category
    Drug
    Distribution
    0 states