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.

2351–2375 of 2769

  • LowFDA (Drugs)·D-66373-001·2013-10-16

    Sandoz Recalls Hydroxychloroquine Tablets Due to Illegible Logo

    Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets because the logo on some tablets is illegible.

    Product
    Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2305-2013·2013-10-09

    Atrium Flixene IFG Vascular Grafts Recalled for Label Adhesion Issue

    Atrium Medical Corporation is recalling Flixene IFG Vascular Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2316-2013·2013-10-09

    Atrium Medical Recalls Advanta SST Grafts Due to Label Adhesion Issue

    Atrium Medical Corporation is recalling Advanta SST Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1067-2013·2013-10-09

    Osmotica Recalls Venlafaxine Extended Release Tablets for Dissolution Failure

    Osmotica Pharmaceutical Corp. is recalling specific lots of Venlafaxine extended release tablets because they failed to meet dissolution specifications at 18 months.

    Product
    Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1965-2013·2013-10-09

    Green Mountain Coffee Recalls Tully's House Blend K-Cup Packs

    Green Mountain Coffee Roasters is recalling Tully's House Blend K-Cup packs because regular caffeinated units were packaged in decaffeinated retail boxes.

    Product
    Tullys¿ House Blend Coffee 12-ct K-Cup¿ packs; Product Code: 8802 (Case of 6 - 12 count retail boxes) UPC: 10099555088028
    Category
    Food
    Distribution
    5 states
  • LowFDA (Food)·F-1934-2013·2013-10-02

    Healthmaxx Global Recalls MAX Nitric Oxide Enhance Due to Mislabeling

    Healthmaxx Global Inc. is voluntarily recalling MAX Brand Nitric Oxide Enhance dietary supplements because the label does not match the actual product or ingredients.

    Product
    MAX Brand Nitric Oxide Enhance, 90 Count Capsules Product labeling reads in part:"MAX Nitric Oxide Enhance***DIETARY SUPPLEMENT 90 Capsules***0 65176 55958 5***Manufactured in FDA Approved Facility for:HealthMax Products Co. Altadena, CA 91001***".
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-1942-2013·2013-10-02

    Healthmaxx Global Recalls Max LUNG AID Dietary Supplement Due to Mislabeling

    Healthmaxx Global Inc. is voluntarily recalling Max LUNG AID Extra Strength dietary supplements because the label does not match the actual product or ingredients.

    Product
    Max LUNG AID Extra Strength 100 capsules Dietary Supplement Product labeling reads in part:"*DIETARY SUPPLEMENT 100 capsules***Manufactured for:HealthMax Products Inc. Altadena, CA 91001***".UPC 0 65176 26289 8
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-1940-2013·2013-10-02

    Healthmaxx Recalls MAX Brand CoQ-10 Capsules Due to Mislabeling

    Healthmaxx Global Inc. is voluntarily recalling MAX Brand CoQ-10 capsules because the label does not match the actual product or ingredients contained.

    Product
    MAX Brand CoQ-10, 780mg, 300 Count Capsules. Product labeling reads in part:"MAX CoQ-10 80 mg***DIETARY SUPPLEMENT 300 Capsules***6 65176 25166 5***Manufactured in FDA Approved Facility for:HealthMax Products Inc. Altadena, CA 91001***".
    Category
    Food
    Distribution
    3 states
  • LowFDA (Devices)·Z-2255-2013·2013-09-25

    King LT-D Oropharyngeal Airways Recalled for Packaging Labeling Error

    King Systems Corp. is recalling King LT-D Oropharyngeal Airways because size 5 units were packaged in pouches labeled as size 2.5.

    Product
    King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach conten
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1061-2013·2013-09-25

    Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Defective Seals

    Watson Laboratories is recalling 875 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets because defective bottles may have improperly seated tamper-evident seals.

    Product
    Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1906-2013·2013-09-25

    Novartis Recalls Benefiber Fiber Supplement Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling 419,040 units of Benefiber chewable tablets because the lot number and expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Benefiber, Fiber Supplement, Assorted Fruit, Sugar Free, 100ct chewable tablets. Novartis Consumer Health, Inc, Parsippany, NJ.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1904-2013·2013-09-25

    Novartis Recalls Benefiber Fiber Supplement Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling specific lots of Benefiber Orange Creme Chewables because the lot number and expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Benefiber, Fiber Supplement, Orange Creme Chewables, Sugar Free, 36ct and 100ct chewable tablet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1903-2013·2013-09-25

    Novartis Recalls Benefiber Wild Berry Chewables Due to Illegible Labeling

    Novartis Consumer Health is recalling specific lots of Benefiber Wild Berry Chewables because the lot number and expiration date may be illegible on the outer packaging.

    Product
    Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable tablets bottle. Novartis Consumer Health, Inc, Parsippany, NJ.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1905-2013·2013-09-25

    Novartis Recalls Benefiber Fiber Supplement Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Benefiber fiber supplement bottles because the lot number and expiration date may be illegible on the outer packaging.

    Product
    Benefiber, Fiber Supplement, 72ct and 114 caplet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1907-2013·2013-09-25

    Novartis Recalls Benefibre Orange Creme Chewables Due to Illegible Labeling

    Novartis Consumer Health is recalling specific lots of Benefibre Orange Creme Chewables because the lot number and expiration date may be illegible on the packaging.

    Product
    Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. Foreign labeling: Novartis Consumer Health Canada Inc, Mississauga, ON.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2121-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Panels Recalled for Misreads

    Siemens is recalling Microscan Synergies Plus Negative panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels &#38; MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative ba
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2165-2013·2013-09-18

    Baxa Vial Adapter Recall for Incorrect Expiry Date

    Baxter Healthcare is voluntarily recalling one lot of Baxa Vial Adapters due to an incorrect expiry date.

    Product
    Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Food)·F-1872-2013·2013-09-11

    Greenland Trading Recalls El Basham Apricot Paste for Missing English Labeling

    Greenland Trading Corp is recalling El Basham Apricot Dried Paste because the product does not declare its identity in English. The recall covers 100 cases distributed to five states.

    Product
    El Basham Weight 400 g Ingredients: Natural Apricot Juice, Glucose, Sugar, Oil. Made by: For the Owner of the Trade Mark ABU Ode h Bros Co. Amok St. Aman -Jordan Tel +962 6 4914961 Fax +962 6 4907878 Remaining information is in Arabic.
    Category
    Food
    Distribution
    5 states
  • LowFDA (Food)·F-1869-2013·2013-09-11

    La Terra Fina Spinach Artichoke Dip Recalled for Labeling Error

    La Terra Fina is recalling one lot of Spinach Artichoke and Parmesan Dip because the label displays the ingredient and nutrition information for Caramelized Onion Dip.

    Product
    Chunky Spinach Artichoke and Parmesan Dip: Gluten Free, Trans Fat Free. Net WT. 10 oz., (.625 lb,284g Made with real cream cheese. Plastic square tub La Terra Fina Union City, CA 94587
    Category
    Food
    Distribution
    4 states
  • LowFDA (Devices)·Z-2131-2013·2013-09-11

    Copan WASP Instrument Recalled for Software Upgrade to Prevent Table Rotation

    Copan Italia is recalling 63 WASP instruments to upgrade software and eliminate a very low risk of the broth table rotating while the door is open.

    Product
    WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Food)·F-1875-2013·2013-09-11

    Justin's Nut Butter Recalled for Foreign Metallic Fragments

    Justin's Nut Butter is voluntarily recalling specific lots of Maple Almond Butter and Chocolate Hazelnut Butter due to the presence of foreign metallic fragments.

    Product
    Chocolate Hazelnut Butter 16oz Jar (Unit UPC 894455000490, Case UPC 894455000612)
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2081-2013·2013-09-04

    Remel Recalls Oxoid Nitrofurantoin Antimicrobial Susceptibility Test Discs

    Remel Inc is recalling specific lots of Oxoid Nitrofurantoin test discs because they may provide false susceptibility results.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test me
    Category
    Medical Device
    Distribution
    17 states
  • LowFDA (Devices)·Z-2096-2013·2013-09-04

    Celera OLA Buffer Recalled for Incorrect Concentration Units

    Celera Corporation is recalling OLA Buffer for Laboratory Use because the package insert listed the wrong concentration units.

    Product
    OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 50003300; Store at d - 15¿C. Product Usage: General Purpose Reagent for laboratory use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1860-2013·2013-09-04

    Nature's Earthly Choice Organic Quinoa Recalled for Sand and Grit

    Global Juices & Fruits LLC is recalling Nature's Earthly Choice Organic Quinoa because it may contain sand and grit.

    Product
    Nature's Earthly Choice Organic Quinoa Distributed by Nature's Earthly Choice Eagle, ID 83616 Product of Bolivia a) Net Wt 2 lbs. - UPC 897034002267 b) Net Wt 4 lbs.- UPC 897034002021 packaged in re-sealable bags
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-896-2013·2013-08-28

    Stayma Recalls Duet DHA 400 ec Due to Subpotent Beta Carotene

    Stayma Consulting Service is recalling specific lots of Duet DHA 400 ec because the beta carotene (Vitamin A) content is subpotent.

    Product
    Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-809-30) and Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331
    Category
    Drug
    Distribution
    Distributed nationwide