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.

951–975 of 2769

  • LowFDA (Food)·F-1768-2018·2018-08-15

    Kraft Heinz Recalls Asian Style Sesame Ginger Dressing Due to Spoilage

    Kraft Heinz is recalling 19,560 cases of Food Network Kitchen Inspirations Asian Style Sesame Ginger Dressing due to premature spoilage caused by lactic acid producing bacteria.

    Product
    Food Network Kitchen Inspirations Asian Style Sesame Ginger Dressing. 12 oz glass bottle, 6 bottles per case Shelf Stable and Refrigerate After Opening UPC 0021000068876
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1047-2018·2018-08-15

    Right Value Drug Stores Recalls Testosterone Pellets Due to Labeling Error

    Right Value Drug Stores is recalling 4,800 Testosterone 200 mg Pellets because the label contains an incorrect expiration date.

    Product
    Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1035-2018·2018-08-15

    Baxter Recalls Levofloxacin Injection Due to High Potency Levels

    Baxter Healthcare is recalling specific lots of Levofloxacin Injection in 5% Dextrose because the solution concentration was higher than specified.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2598-2018·2018-08-08

    BD FACS Universal Loader Recalled for Insufficient Locking Mechanism

    Becton, Dickinson and Company is recalling 8 BD FACS Universal Loader devices because the solenoid plunger tip is too short to lock securely during use.

    Product
    BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It c
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Drugs)·D-1031-2018·2018-08-08

    Renaissance Lakewood Recalls Fluconazole Injection Bags Due to Stability Failures

    Renaissance Lakewood, LLC is recalling 3,000 bags of Fluconazole Injection due to elevated sodium chloride and water vapor levels.

    Product
    Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2574-2018·2018-08-08

    Diamedix EBV Test Kit Recalled for Gel-Like Contaminant

    Diamedix Corporation is recalling 147 units of the Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit due to a gel-like contaminant that may affect product performance.

    Product
    Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-2573-2018·2018-08-08

    Diamedix Is-Mumps IgG Test Kit Recalled for Gel-Like Contaminant

    Diamedix Corporation is recalling 505 units of the Is-Mumps IgG Enzyme Immunoassay Test Kit because a gel-like contaminant may affect product performance.

    Product
    Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Drugs)·D-1032-2018·2018-08-08

    Fluconazole Injection Recalled for Elevated Water Vapor Levels

    Renaissance Lakewood, LLC is recalling Fluconazole Injection bags due to elevated water vapor levels. The recall covers 3,664 bags distributed nationwide and in Puerto Rico.

    Product
    Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1050-2018·2018-08-08

    Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Stability Test Failure

    Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because an out-of-specification result was found in a stability study. The product was distributed throughout the United States.

    Product
    MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
    Category
    Drug
    Distribution
    0 states
  • LowUSDA FSIS·067-2018·2018-08-06

    StoneRidge Pork and Beef Bologna Recalled for Misbranding

    StoneRidge Wholesale Division LLC is recalling approximately 656 pounds of pork and beef bologna products because they contain undeclared sodium nitrite and sodium erythorbate.

    Product
    StoneRidge Wholesale Division LLC — Recall Notification Report 067-2018 (Pork and Beef Bologna Products)
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1664-2018·2018-08-01

    Orca Bay Foods Recalls Decomposed Wild Mahi-Mahi Loins

    Orca Bay Foods LLC is recalling 17 cases of decomposed wild-caught mahi-mahi loins sold in Florida, North Carolina, and Maryland.

    Product
    Consumer Packaging: WELLSLEY FARM WILD CAUGHT MAHI-MAHI LOINS, UPC: 8 88670 00983 3, plastic 2lb retail bag, Keep Frozen. Master Carton: BJ s Wholesale Club Wild Mahi Mahi Loins Skinless Bone Out 16/2Lb. VP Bags. NET WT. 32 LB. Item Code: 32272, UPC: 0 29714 32727 2. Product
    Category
    Food
    Distribution
    3 states
  • LowFDA (Devices)·Z-2529-2018·2018-08-01

    Nobel Biocare Multi-Unit Abutment Recalled for Missing Label Information

    Nobel Biocare is recalling 74 units of Multi-Unit Abutments because the product labels are missing the lot number, expiration date, and other required information.

    Product
    Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0980-2018·2018-08-01

    Major Pharmaceuticals Recalls Enalapril Maleate Tablets Due to Impurities

    Major Pharmaceuticals is recalling 5,933 cartons of Enalapril Maleate Tablets, 5 mg, due to out-of-specification degradation products.

    Product
    Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0992-2018·2018-08-01

    Aidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product

    Aidarex Pharmaceuticals is recalling 25 bottles of Enalapril Maleate 5mg due to out-of-specification degradation results during stability testing.

    Product
    Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0990-2018·2018-08-01

    Aidarex Recalls Enalapril Maleate 2.5mg Due to Stability Issues

    Aidarex Pharmaceuticals is recalling 11 bottles of Enalapril Maleate 2.5mg because out-of-specification degradation products were found during stability testing.

    Product
    Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2551-2018·2018-08-01

    ImplantDirect Dental Implants Recalled for Incorrect Vial Label Part Number

    Implant Direct Sybron Manufacturing is recalling 124 units of ImplantDirect dental implants because the main vial label lists an incorrect part number, although the cap label is correct.

    Product
    ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
    Category
    Medical Device
    Distribution
    16 states
  • LowFDA (Devices)·Z-2384-2018·2018-07-18

    Arrow International Recalls VPS TipTracker Stylet Accessory Due to Labeling Issues

    Arrow International Inc. is recalling 2,070 units of the VPS TipTracker Stylet Accessory because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    Product
    VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0915-2018·2018-07-18

    American Health Packaging Recalls Enalapril Maleate Tablets Due to Impurities

    American Health Packaging is recalling specific lots of Enalapril Maleate Tablets USP, 5 mg, due to out-of-specification results for a degradation product.

    Product
    Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0913-2018·2018-07-18

    Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures

    Wockhardt Limited is recalling specific batches of Enalapril Maleate Tablets USP because they failed impurity and degradation specifications.

    Product
    Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0978-2018·2018-07-18

    Mylan Recalls Subpotent Triamterene and Hydrochlorothiazide Tablets Nationwide

    Mylan Pharmaceuticals is voluntarily recalling 28,436 bottles of Triamterene and Hydrochlorothiazide Tablets because the medication was found to be subpotent.

    Product
    Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0907-2018·2018-07-11

    Equate ClearLAX Recalled for Unfiled NDC Numbers on Labeling

    Lupin Somerset is recalling Equate ClearLAX laxative bottles due to unfiled NDC numbers on the labels. This is a Class III recall with no reported health risks.

    Product
    Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0893-2018·2018-07-11

    Qualgen Recalls Testosterone Pellets Due to Incorrect Lot and Expiration Dates

    Qualgen, LLC is recalling Testosterone 200 mg Pellets because the vials have incorrect or missing lot and expiration dates.

    Product
    TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2333-2018·2018-07-11

    Ecolab Microtek Rolled Probe Cover Recalled for Incorrect Instructions

    Ecolab Inc. is recalling 65 cases of Microtek Rolled Probe Covers because the products were shipped with incorrect instructions for use.

    Product
    ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluid
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Drugs)·D-0892-2018·2018-07-11

    Qualgen Recalls Estradiol Pellets Due to Incorrect or Missing Lot and Expiration Dates

    Qualgen, LLC is recalling Estradiol 20mg Pellets because the vials have incorrect or missing lot and expiration dates.

    Product
    ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01
    Category
    Drug
    Distribution
    Distributed nationwide