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.

1226–1250 of 2769

  • LowUSDA FSIS·086-2017·2017-08-01

    JBS USA Recalls Ground Beef Due to Styrofoam Contamination

    JBS USA is recalling approximately 4,922 pounds of ground chuck beef produced on July 15, 2017, due to possible contamination with shredded Styrofoam packaging.

    Product
    JBS Prepared Foods-Tupelo Facility — JBS USA Inc. Recalls Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0980-2017·2017-07-26

    Hospira Recalls Argatroban Injection Due to Impurity Specification Failure

    Hospira is recalling 701 vials of Argatroban Injection because a denitroquinoline-related impurity exceeded specifications during testing.

    Product
    Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0982-2017·2017-07-26

    Shionogi Recalls PONSTEL Capsules Due to Failed Dissolution Specifications

    Shionogi Inc. is recalling 455 bottles of PONSTEL capsules because stability testing showed low dissolution results.

    Product
    PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0983-2017·2017-07-26

    Teva Recalls Buprenorphine and Naloxone Tablets Due to Impurities

    Teva Pharmaceuticals is recalling specific lots of Buprenorphine and Naloxone Sublingual Tablets because they failed impurity specifications.

    Product
    Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0998-2017·2017-07-26

    Obagi-C Rx Night Cream Recalled for Missing Safety Information

    Valeant Pharmaceuticals is recalling 844 bottles of Obagi-C Rx System C-Therapy Night Cream because the bottles are missing the product insert and outer carton containing safety instructions.

    Product
    Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0981-2017·2017-07-26

    Shionogi Recalls Mefenamic Acid Capsules for Dissolution Failures

    Shionogi Inc. is recalling Mefenamic Acid 250mg capsules because stability testing showed low dissolution results.

    Product
    Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2725-2017·2017-07-19

    AMS Diagnostics Recalls Medica ISE Module Calibrant A Due to Physical Defects

    AMS Diagnostics is recalling 9 units of Medica ISE Module Calibrant A because the lot was not functioning properly and did not exhibit correct physical properties.

    Product
    Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowNHTSA·17V445000·2017-07-14

    Forest River Recalls 2017 Rockwood Travel Trailers for VIN Label Error

    Forest River is recalling 2017 Rockwood travel trailers because an incorrect check digit on the VIN label may hinder vehicle registration and safety recall tracking.

    Product
    FOREST RIVER — FOREST RIVER ROCKWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0936-2017·2017-07-12

    PharMEDium Recalls Bupivacaine Pumps Due to Incorrect Labeling

    PharMEDium Services is recalling seven Bupivacaine HCl ON-Q pumps because of incorrect or missing lot and expiration dates.

    Product
    Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-023-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0935-2017·2017-07-12

    PharMEDium Recalls Bupivacaine Pumps Due to Incorrect Labeling

    PharMEDium Services is recalling two Bupivacaine HCl ON-Q pumps due to incorrect or missing lot and expiration date labeling.

    Product
    Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0934-2017·2017-07-12

    PharMEDium Recalls Ropivacaine HCl Injection Due to Labeling Errors

    PharMEDium Services, LLC is recalling 21 pumps of Ropivacaine HCl 0.2% injection due to incorrect or missing lot and expiration dates.

    Product
    Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-100-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0933-2017·2017-07-12

    PharMEDium Recalls Ropivacaine Pumps Due to Incorrect Lot and Expiration Dates

    PharMEDium Services, LLC is recalling 10 Ropivacaine HCl 0.2% ON-Q pumps nationwide due to incorrect or missing lot and expiration dates.

    Product
    Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2659-2017·2017-07-12

    Encore Medical Recalls 3DKnee Tibial Inserts Due to Mis-Packaging

    Encore Medical is recalling 3DKnee Tibial Inserts because a size 6 left box contained a size 8 right insert.

    Product
    3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0931-2017·2017-07-12

    PharMEDium Recalls Ropivacaine Pumps Due to Labeling Errors

    PharMEDium Services is recalling 22 Ropivacaine HCl pumps nationwide because of incorrect or missing lot and expiration dates.

    Product
    Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0930-2017·2017-07-12

    PharMEDium Recalls Ropivacaine Pumps Due to Incorrect Labeling

    PharMEDium Services is recalling 79 Ropivacaine HCl IV pumps because of incorrect or missing lot and expiration dates.

    Product
    Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-256-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0932-2017·2017-07-12

    PharMEDium Recalls Ropivacaine Pumps Due to Labeling Errors

    PharMEDium Services is recalling 147 Ropivacaine HCl IV pumps nationwide because of incorrect or missing lot and expiration dates.

    Product
    Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2631-2017·2017-07-05

    Medtest CRP Calibrator and Standard Sets Recalled for Unit Mislabeling

    Medtest Holdings is recalling Pointe Scientific CRP calibrator and standard sets because vial labels incorrectly list units as mg/dl instead of mg/L.

    Product
    Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manuf
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-2623-2017·2017-07-05

    CryoLife BioGlue Surgical Adhesive Recalled for Incorrect Lot Labeling

    CryoLife, Inc. is recalling 705 boxes of BioGlue Surgical Adhesive because 9 boxes had incorrect lot numbers on their courtesy labels.

    Product
    BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0928-2017·2017-07-05

    BuPROPion HCL Tablets Recalled for Moisture Content Failures

    Mckesson Packaging Services is recalling BuPROPion HCL Tablets, 75 mg, due to out-of-specification moisture content.

    Product
    BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2650-2017·2017-07-05

    Medtest Liquid Creatine Kinase Reagent Set Recalled for Labeling Mismatch

    Medtest Holdings is recalling Pointe Scientific Liquid Creatine Kinase Reagent Sets because the product insert does not match the approved premarket notification.

    Product
    Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2627-2017·2017-07-05

    Euro Diagnostica Recalls DIASTAT ANA Kits Due to Incorrect Expiration Date

    Euro Diagnostica AB is recalling 501 units of DIASTAT ANA kits because the packaging displayed the original expiration date instead of the shortened one.

    Product
    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), S
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Drugs)·D-0925-2017·2017-07-05

    L. Perrigo Recalls Walgreens Cold and Flu Combo Packs Due to Label Error

    L. Perrigo is recalling 1,998 Walgreens Daytime and Nighttime Cold & Flu combo packs in Illinois because the packaging sleeve incorrectly identifies the contents as Day-Night Cold and Flu instead of Day-Night Cough Liquid.

    Product
    Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0926-2017·2017-07-05

    Gaviscon Chewable Tablets Recalled for High Magnesium Levels

    Sanofi-Aventis is recalling Gaviscon chewable tablets due to high out-of-specification magnesium levels. The recall covers 2,980 bottles distributed in the US, Puerto Rico, and the UK.

    Product
    Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.
    Category
    Drug
    Distribution
    Distributed nationwide