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.

976–1000 of 2741

  • 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…
    Category
    Medical Device
    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-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 (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).…
    Category
    Medical Device
    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-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-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
  • LowFDA (Devices)·Z-2377-2018·2018-07-11

    Medtronic MiniMed Paradigm Veo Insulin Pump Recalled for Arabic Translation Error

    Medtronic is recalling 239,859 MiniMed Paradigm Veo insulin pumps due to an error in the Arabic language translation of the Predictive Alerts setting screen.

    Product
    Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2332-2018·2018-07-11

    Ecolab Microtek Rolled Probe Cover Recalled for Incorrect Instructions

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

    Product
    ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, 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…
    Category
    Medical Device
    Distribution
    6 states
  • 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…
    Category
    Medical Device
    Distribution
    6 states
  • 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
  • LowUSDA FSIS·059-2018·2018-07-06

    Tillamook Country Smoker Recalls Teriyaki Beef Jerky Due to Misbranding

    Tillamook Country Smoker is recalling approximately 102 pounds of teriyaki beef jerky because the products may contain undeclared monosodium glutamate (MSG).

    Product
    Tillamook Country Smoker, LLC — Recall Notification Report 059-2018 (Beef Jerky Products)
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-1592-2018·2018-07-04

    Absonutrix Recalls Vitamin B12 Supplement Lacking Listed Ingredient

    Absonutrix is recalling Lyfetrition Vitamin B12 supplements because the product did not contain the vitamin listed on the label.

    Product
    Lyfetrition Live Life Nutritiously Vitamin B12 2 FL. OZ bottle Supplement Facts Serving Size:***Vitamin B-12 (as Methylcobalamyn) ABSONUTRIX 5500 Adams Farm Lane, Suite 206 Greensboro NC 27407 UPC 7 00443 88822 6
    Category
    Food
    Distribution
    22 states
  • LowFDA (Food)·F-1621-2018·2018-07-04

    McEvoy Ranch Extra Virgin Olive Oil Recalled for Cracking Bottles

    McEvoy of Marin, LLC. is recalling 6,000 bottles of 1-liter McEvoy Ranch 100% Certified Extra Virgin Olive Oil because inconsistent filling caused bottles to crack and break.

    Product
    McEvoy Ranch 100% Certified Extra VirginOlive Oil; Made in California; 1 L, 33,8 FL OZ UPC 6 34832 00291
    Category
    Food
    Distribution
    0 states
  • LowFDA (Drugs)·D-0887-2018·2018-06-27

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

    Dr. Reddy's Laboratories is recalling specific lots of Atorvastatin Calcium tablets because they failed impurity and degradation specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2257-2018·2018-06-27

    Quantimetrix Recalls Dropper Plus Urinalysis Control Kits Due to Lot Error

    Quantimetrix Corporation is recalling 20 kits of Dropper Plus Point-of-Care Urinalysis Dipstick Control because they contained an incorrect lot of Level 1 vials.

    Product
    Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for…
    Category
    Medical Device
    Distribution
    1 state
  • LowUSDA FSIS·054-2018·2018-06-25

    Land O'Frost Recalls 4,944 Pounds of Misbranded Black Forest Ham

    Land O'Frost is recalling 4,944 pounds of Black Forest Ham because the back of the package incorrectly identifies the product as Honey Smoked Turkey Breast.

    Product
    Land O'Frost, Inc. — Recall Notification Report 054-2018 (Ham Products)
    Category
    Food
    Distribution
    5 states
  • LowFDA (Drugs)·D-0877-2018·2018-06-20

    Mylan Recalls Maxzide-25 Tablets Due to Slightly High Potency

    Mylan Pharmaceuticals is recalling 1,620 bottles of Maxzide-25 tablets because routine stability testing showed potency slightly above specification.

    Product
    Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-2140-2018·2018-06-20

    Immunalysis Recalls EDDP Urine Control Set Due to Specification Failure

    Immunalysis is recalling 37 kits of EDDP Urine Control Set 1 because the High control fails to meet specifications, potentially producing inaccurate test results.

    Product
    lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test…
    Category
    Medical Device
    Distribution
    14 states
  • LowFDA (Devices)·Z-2105-2018·2018-06-13

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope is recalling 194 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that triggers a monitor error.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2104-2018·2018-06-13

    Datascope Cardiopulmonary Bypass Tubing Kit Recalled for Cuvette Failure

    Datascope is recalling 19 cardiopulmonary bypass tubing kits due to a potential cuvette failure that causes monitor error messages.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
    Category
    Medical Device
    Distribution
    3 states