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.

1726–1750 of 2741

  • LowFDA (Drugs)·D-0821-2016·2016-04-20

    Impax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling

    Impax Laboratories is recalling 42,239 bottles of Fenofibrate Capsules (Micronized) 200 mg because some bottles have incorrect or missing lot and expiration dates.

    Product
    Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0809-2016·2016-04-13

    Bio-pharm Recalls Ranitidine Syrup Due to Elevated Impurity Levels

    Bio-pharm, Inc. is recalling Ranitidine Syrup because routine stability testing detected elevated impurity levels.

    Product
    Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1013-2016·2016-04-13

    Immuno-Dynamics Recalls Colostrum Powder for Incorrect Allergen Labeling

    Immuno-Dynamics, Inc. is recalling PerCoBa and Synertek colostrum powder because the labels state 'contains dairy' instead of 'contains milk.'

    Product
    Colostrum Powder, Dietary Supplement, Allergen statement: contains dairy. Colostrum (bovine) packaged in the following sizes and brand names: 1. PerCoBa Extra Edge Net Weight 150 grams, UPC 90576-00099. 3,000 mg Colostrum (bovine) per 2 teaspoons. Immuno-Dynamics, Inc.…
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0801-2016·2016-04-13

    Virtus Pharmaceuticals Recalls Prenatal Supplement Due to Leaking Capsules

    Virtus Pharmaceuticals is recalling prenatal/postnatal folic acid supplements because the capsules may leak. The recall covers 688 bottles distributed nationwide.

    Product
    VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0811-2016·2016-04-13

    Apace KY LLC Recalls Minocycline Capsules Due to Mislabeled Lot Numbers

    Apace KY LLC is recalling 291 cartons of Minocycline Hydrochloride Capsules because individual blisters are mislabeled with an incorrect lot number.

    Product
    Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1319-2016·2016-04-13

    Richard-Allan Scientific Recalls Type 3 Paraffin Due to Mislabeling

    Richard-Allan Scientific is recalling Type 3 Paraffin because customers found Type 6 Paraffin inside the boxes. The product is used for histology tissue processing.

    Product
    Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and…
    Category
    Medical Device
    Distribution
    12 states
  • LowFDA (Devices)·Z-1285-2016·2016-04-06

    Ossur Recalls Knee Shields and Medical Devices Due to Packaging Defect

    Ossur Americas is recalling various medical devices, including knee shields and walkers, because the packaging is defective.

    Product
    Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in motocross activities.
    Category
    Medical Device
    Distribution
    48 states
  • LowFDA (Drugs)·D-0783-2016·2016-04-06

    Praxair Recalls Medical Air Cylinders Due to Odor Complaint

    Praxair Inc. is recalling 382 cylinders of medical air nationwide after a customer reported an odor when turning on a cylinder.

    Product
    UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0800-2016·2016-04-06

    Pfizer Recalls Robitussin Peak Cold Liquid Due to Labeling Error

    Pfizer is recalling 63,636 bottles of Robitussin Peak Cold Liquid nationwide due to a label mix-up. Consumers should stop using the product and return it to the point of purchase.

    Product
    Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1177-2016·2016-03-23

    Volk Optical Recalls G-4 Gonio Lenses Due to Incorrect Lot Number

    Volk Optical Inc is recalling G-4 Small Ring Gonio Lenses because the incorrect lot number was engraved on the product.

    Product
    Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0776-2016·2016-03-23

    Medical Park Homecare Recalls Compressed Oxygen Cylinders Due to Gauge Issues

    Medical Park Homecare is recalling compressed oxygen cylinders filled using out-of-date gauges. The recall involves M6, D, and E tanks distributed in Oklahoma.

    Product
    Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0773-2016·2016-03-23

    Teva Recalls Nabumetone Tablets Due to Missing Labels and Leaflets

    Teva Pharmaceuticals USA is recalling 576 bottles of Nabumetone 750 mg tablets because they lack required leaflets and approved labels.

    Product
    NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0778-2016·2016-03-23

    Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags

    Pharmedium Services, LLC is recalling specific lots of repinephrine bitartrate injection bags due to subpotency and discoloration confirmed by FDA analysis.

    Product
    NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1173-2016·2016-03-23

    Collagen Matrix Recalls ZCORE Porcine Xenograft Syringes for Malfunction

    Collagen Matrix Inc is recalling 200 units of ZCORE Porcine Xenograft Particulate in Syringe because the syringes were not working properly.

    Product
    ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0775-2016·2016-03-23

    Virt-Nate Prenatal Supplement Recalled for Incorrect Tablet Imprinting

    Virtus Pharmaceuticals is recalling Virt-Nate Prenatal/Postnatal supplements because some bottles contain tablets with the wrong identification code.

    Product
    Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1048-2016·2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Service Manual Error

    GE Medical Systems is recalling 25 CT and PET CT scanner systems because their service manuals contain an incorrect torque value.

    Product
    LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole…
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-1052-2016·2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Manual Error

    GE Medical Systems is recalling specific CT and PET CT scanners because service manuals contained an incorrect torque value.

    Product
    LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body…
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Drugs)·D-0770-2016·2016-03-16

    FDA Recalls Atorvastatin Calcium 80 mg Due to Impurity Failures

    Golden State Medical Supply Inc. is recalling specific lots of Atorvastatin Calcium 80 mg tablets because they failed impurity and degradation specifications.

    Product
    Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0769-2016·2016-03-16

    Atorvastatin Calcium 40 mg Recalled for Impurity Failures

    Golden State Medical Supply Inc. is recalling Atorvastatin Calcium 40 mg tablets due to failed impurities and degradation specifications.

    Product
    Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1053-2016·2016-03-16

    GE Medical Systems Recalls CT and PET Scanners for Incorrect Torque Values

    GE Medical Systems is recalling 104 CT and PET/CT scanners worldwide because service manuals contained incorrect torque values.

    Product
    LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body…
    Category
    Medical Device
    Distribution
    4 states