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.

1976–2000 of 2769

  • LowFDA (Drugs)·D-0962-2015·2015-04-29

    Nomax Recalls GLOSTRIPS Ophthalmic Strips for Packaging Degradation

    Nomax Inc. is recalling GLOSTRIPS ophthalmic strips because packaging degradation may affect the uniformity of the rose bengal dosage.

    Product
    GLOSTRIPS — GLOSTRIPS (ROSE BENGAL SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0963-2015·2015-04-29

    Nomax Recalls Fluorescein Sodium Ophthalmic Strips for Content Uniformity Issues

    Nomax Inc is recalling Fluorescein Sodium Ophthalmic Strips because packaging degradation may affect dosage uniformity. The recall covers 62,691 cartons distributed in the US and internationally.

    Product
    Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode (01)00317478404019; packaged in 100-count strips per carton, (NDC 17478-404-01), UPC 3 17478 40401 9, Manufactured for: Akorn, Inc., Lake Forest, IL 60045.; and
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1411-2015·2015-04-22

    Biomet 3i Recalls Discolored OSSEOTITE Dental Implants

    Biomet 3i is recalling 620 OSSEOTITE dental implants that were discolored due to contact with residual machine fluid.

    Product
    OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0487-2015·2015-04-22

    Apotex Recalls Bromfenac Ophthalmic Solution Due to CGMP Deviations

    Apotex Inc. is recalling 33,795 bottles of Bromfenac Ophthalmic Solution 0.09% because an excipient was not re-tested at the appropriate date.

    Product
    Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0489-2015·2015-04-22

    Cardinal Health Recalls Potassium Chloride Tablets Due to Incorrect Package Insert

    Cardinal Health is recalling specific lots of potassium chloride extended-release tablets because they were packaged with the wrong package insert.

    Product
    Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manufactured by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 for Sandoz, Inc., Princeton, NJ 08540 Repackaged by Cardinal Health Zanesvil
    Category
    Drug
    Distribution
    1 state
  • LowUSDA FSIS·065-2015·2015-04-20

    Michigan Brand Recalls Smoked Turkey and Beef for Labeling Error

    Michigan Brand, Inc. is recalling approximately 737 pounds of smoked turkey and beef products because the labels failed to list sodium nitrite as an ingredient.

    Product
    Michigan Brand, Inc. — Recall Notification Report 065-2015 (Turkey and Beef)
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0435-2015·2015-04-15

    Mylan Recalls Fexofenadine HCl Tablets Due to Impurity Failures

    Mylan Pharmaceuticals is recalling specific lots of Fexofenadine HCl 60 mg tablets because they failed impurity specifications. The recall covers 13,856 bottles distributed nationwide.

    Product
    Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1401-2015·2015-04-15

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Cards Due to Labeling Error

    Biomerieux Inc is recalling Vitek 2 AST-P635 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended organism.

    Product
    Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1333-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial(0.5ml) for feces test 4. Swab for Nasal test.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1402-2015·2015-04-15

    Biomerieux Recalls Vitek 2 AST-P640 Cards Due to Labeling Error

    Biomerieux Inc is recalling Vitek 2 AST-P640 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended use organism.

    Product
    Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D00432-2015·2015-04-15

    Qualitest Recalls Promethazine VC With Codeine Syrup Due to Impurity

    Qualitest Pharmaceuticals is recalling Promethazine VC with Codeine Syrup because a stability lot failed impurity specifications.

    Product
    PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1403-2015·2015-04-15

    Biomerieux Recalls Vitek 2 AST-P641 Cards Due to Labeling Error

    Biomerieux Inc is recalling Vitek 2 AST-P641 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended use organism.

    Product
    Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
    Category
    Medical Device
    Distribution
    0 states
  • LowUSDA FSIS·058-2015·2015-04-10

    Cargill Recalls Ground Beef Patties Due To Possible Foreign Matter Contamination

    Cargill Meat Solutions is recalling approximately 8,294 pounds of ground beef patties that may be contaminated with blue string. The products were shipped to Connecticut and Maryland.

    Product
    Cargill Meat Solutions Corporation — Cargill Recalls Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-1785-2015·2015-04-08

    French Broad Chocolates Recalls Bubbie's Almond Bar Due to Cacao Moth

    French Broad Luscious Chocolates is recalling Bubbie's Almond Bars because of the presence of a cacao moth in the almonds.

    Product
    French Broad Chocolates, Bubbie's Almond Bar, 60g (2.1 oz) bar, with aluminum foil with polyester ribbon & paper outer wrapper
    Category
    Food
    Distribution
    7 states
  • LowFDA (Food)·F-1805-2015·2015-04-08

    Cheryl's Bunny Head Cookies Recalled for Incorrect Packaging Film

    Cheryl's is recalling Buttercream Frosted Cut-Out Bunny Head Cookies because they were packed in film lacking the ingredient cocoa.

    Product
    Cheryl's Buttercream Frosted Cut-Out BUNNY HEAD COOKIES, Net Wt 1.5oz (43g), Cheryl's Westerville, Ohio 43082 www.Cheryls.com ALLERGEN STATEMENT: Contains Wheat, Soy, Milk and Eggs. Produced in a plant that also handles peanuts and tree nuts.
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-1294-2015·2015-03-25

    LeMaitre Vascular TCI System Recalled for Incorrect Expiration Date Labeling

    LeMaitre Vascular is recalling 54 units of the Tumescent Catheter Inversion System because they were mislabeled with an incorrect expiration date.

    Product
    LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Drugs)·D-0412-2015·2015-03-25

    Mylan Recalls Doxorubicin Vials Due to Potential Mispackaging

    Mylan Institutional LLC is recalling 936 vials of Doxorubicin Hydrochloride Injection because they may have been mispackaged with Ifosfamide Injection.

    Product
    DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1289-2015·2015-03-25

    Siemens N Latex IgM Reagent Recalled for Proficiency Testing Failures

    Siemens Healthcare Diagnostics is recalling specific lots of N Latex IgM reagents because they failed proficiency testing, resulting in low recovery rates for serum samples.

    Product
    N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the eval
    Category
    Medical Device
    Distribution
    7 states
  • LowUSDA FSIS·052-2015·2015-03-25

    Viz Cattle Recalls Flap Meat Beef for Missing Ingredient Labeling

    Viz Cattle is recalling 62,841 pounds of flap meat beef because the product labels lack an ingredient statement. No undeclared allergens or adverse reactions have been reported.

    Product
    Recall Notification Report 052-2015 (Flap Meat Beef)
    Category
    Food
    Distribution
    1 state
  • LowUSDA FSIS·051-2015·2015-03-23

    Stock Yards Meat Packing Recalls Mislabeled Roast Beef Product

    Stock Yards Meat Packing Co. is recalling approximately 2,149 pounds of roast beef mistakenly labeled as corned beef. The product was shipped to businesses in Arizona and California.

    Product
    Stock Yards Meat Packing Co., Inc. Recalls Roast Beef Product Due to Misbranding
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-1408-2015·2015-03-18

    Keystone Food Products Recalls Veggie Sticks and Straws Due to Labeling Error

    Keystone Food Products is recalling specific brands of veggie sticks and straws because the sodium content listed on the label is incorrect.

    Product
    Weis Veggie Sticks Net Wt. 6 oz. Packed For Weis Markets, Inc. Sunbury, PA 17801 With code dates: 10 Dec 2014 thru 7 Apr 2015 Natures Place Veggie Straws Net Wt. 6 oz Distributed By: DZA Brands, LLC, Salisbury NC 28147/Scarborough, ME 04074 With code dates: 6 Jan 2015
    Category
    Food
    Distribution
    8 states
  • LowFDA (Devices)·Z-1264-2015·2015-03-18

    Richard-Allan Scientific Recalls Mislabelled CYTO-STAIN R Stain Bottles

    Richard-Allan Scientific is recalling 132 gallons of CYTO-STAIN R Stain because the bottles were incorrectly labeled as CYTO-STAIN G, although the contents are correct.

    Product
    Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0407-2015·2015-03-18

    Micro Labs Recalls Simvastatin Tablets Due to Impurity Failure

    Micro Labs USA Inc. is recalling specific lots of Simvastatin Tablets, 20mg, because the product failed a known impurity specification.

    Product
    Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1407-2015·2015-03-18

    Keystone Food Products Recalls Veggie Chips for Incorrect Sodium Labeling

    Keystone Food Products Inc. is recalling specific brands of veggie chips because the sodium content on the label is incorrect. The product contains approximately 290 mg of sodium per serving, not the 55 mg claimed.

    Product
    Weis Veggie Chips Net Wt. 6 oz. Packed For Weis Markets, Inc. Sunbury, PA 17801 With code dates: 10 Dec 2014 thru 7 Apr 2015 Natures Place Veggie chips Net Wt. 6 oz Distributed By: DZA Brands, LLC, Salisbury NC 28147/Scarborough, ME 04074 With code dates: 15 Dec 2014 t
    Category
    Food
    Distribution
    8 states
  • LowUSDA FSIS·047-2015·2015-03-17

    Alewel's Country Meats Recalls Buffalo Jerky Due to Misbranding

    Alewel's Country Meats is recalling approximately 134 pounds of Buffalo Jerky because the product was produced using the wrong inspection legend.

    Product
    Alewel's Country Meats — Recall Notification Report 047-2015 (Buffalo Jerky)
    Category
    Food
    Distribution
    1 state