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.

2301–2325 of 2769

  • LowFDA (Devices)·Z-0531-2014·2014-01-01

    C.L.R. Medicals Recalls Viscocel Intraocular Fluid Devices for Regulatory Deficiencies

    C.L.R. Medicals International is recalling Viscocel and Viscocel Plus intraocular fluid devices due to FDA inspection findings of quality system deficiencies and lack of Premarket Approval.

    Product
    Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0560-2014·2014-01-01

    Edwards Lifesciences Recalls Mislabelled Ergonic Double Acting DeBakey Forceps

    Edwards Lifesciences is recalling three units of Ergonic Double Acting DeBakey Forceps due to incorrect laser etching that misidentified the instrument type.

    Product
    Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-382-2014·2014-01-01

    Teva Recalls Qnasl Nasal Aerosol Due to Potential Clogged Stem Valves

    Teva Pharmaceuticals USA is recalling Qnasl Nasal Aerosol units because some may have clogged stem valves, potentially affecting delivery.

    Product
    Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0490-2014·2013-12-25

    Nephros Dual Stage Ultra Filter Brochure Recalled for Misleading Medical Claims

    Nephros Inc is recalling brochures for its Dual Stage Ultra Filter because the materials promoted the product as a medical device.

    Product
    Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-348-2014·2013-12-25

    Tween Brands Recalls Strawberry Hand Sanitizer Due to Labeling Error

    Tween Brands Inc is recalling 86,701 bottles of Believe in Yourself Strawberry Anti bac Justice hand sanitizer because the label incorrectly states the ethyl alcohol content.

    Product
    Believe in Yourself Strawberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz., Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-350-2014·2013-12-25

    Tween Brands Recalls Shine from Within Blueberry Anti-Bac Justice Due to Label Error

    Tween Brands Inc is recalling 25,078 bottles of Shine from Within Blueberry Anti-Bac Justice because the label incorrectly states the ethyl alcohol content is 62% instead of the actual 20%.

    Product
    Shine from within blueberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-353-2014·2013-12-25

    Tween Brands Recalls Hand Sanitizer Due to Alcohol Content Labeling Error

    Tween Brands Inc is recalling 47,343 bottles of hand sanitizer because the label incorrectly states the ethyl alcohol content is 62% instead of the actual 20%.

    Product
    TODAY IS AWESOME! Justice, Cotton Candy anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-360-2014·2013-12-25

    Tween Brands Recalls Girls Rock Justice Hand Sanitizer Due to Label Error

    Tween Brands Inc is recalling 9,558 bottles of Girls Rock Justice hand sanitizer because the label incorrectly states the ethyl alcohol content is 62% instead of 20%.

    Product
    GIRLS ROCK Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-363-2014·2013-12-25

    Tween Brands Recalls Grape Scented Anti-Bac Due to Labeling Error

    Tween Brands Inc is recalling 15,931 bottles of Grape Scented Anti-Bac because the label incorrectly states the ethyl alcohol content is 62% instead of 20%.

    Product
    YOU CANT HANDLE THIS Justice, GRAPE SCENT ANTI BAC, Ethyl Alcohol Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-365-2014·2013-12-25

    Tween Brands Recalls Cherry Scent Anti Bac Due to Label Error

    Tween Brands Inc is recalling 4,692 bottles of BFF's are COOL! Justice Cherry Scent Anti Bac because the label incorrectly states the ethyl alcohol content is 62% instead of the actual 20%.

    Product
    BFF's are COOL! Justice, CHERRY SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-362-2014·2013-12-25

    Tween Brands Recalls I Love Bacon Justice Hand Sanitizer Due to Label Error

    Tween Brands Inc is recalling 16,471 bottles of I Love Bacon Justice hand sanitizer because the label incorrectly states the ethyl alcohol content is 62% instead of the actual 20%.

    Product
    I LOVE BACON Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-359-2014·2013-12-25

    Tween Brands Recalls Grapefruit Anti Bac Justice Due to Label Error

    Tween Brands Inc is recalling 18,492 bottles of Grapefruit anti bac Justice because the label incorrectly states the ethyl alcohol content is 62% instead of 20%.

    Product
    Grapefruit anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Tocopheryl Acetate,*** Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-379-2014·2013-12-25

    Fresenius Kabi Recalls Folic Acid Injection Vials for Impurity Failures

    Fresenius Kabi USA is recalling folic acid injection vials due to failed impurity and degradation specifications at 14 and 15 months.

    Product
    FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-358-2014·2013-12-25

    Tween Brands Recalls Lemon Anti Bac Justice Due to Label Error

    Tween Brands Inc is recalling 27,590 bottles of Lemon Anti Bac Justice because the label incorrectly states the ethyl alcohol content is 62% instead of 20%.

    Product
    Lemon anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-354-2014·2013-12-25

    Tween Brands Recalls Anti-Bacterial Hand Sanitizer Due to Labeling Error

    Tween Brands Inc is recalling 58,054 bottles of LIFE IS SWEET! Justice hand sanitizer because the label incorrectly states the ethyl alcohol content is 62% instead of the actual 20%.

    Product
    LIFE IS SWEET! Justice, Vanilla Scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-352-2014·2013-12-25

    Tween Brands Recalls Justice Anti-Bacterial Hand Sanitizer Due to Labeling Error

    Tween Brands Inc is recalling 65,332 bottles of Justice Chocolate anti-bacterial hand sanitizer because the label incorrectly states the ethyl alcohol content is 62% instead of 20%.

    Product
    FOLLOW YOUR DREAMS! Justice, Chocolate anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0528-2014·2013-12-25

    Remel Recalls Oxoid Ciprofloxacin Test Discs Due to Labeling Error

    Remel Inc is recalling Oxoid Ciprofloxacin test discs because boxes labeled CIP5 may contain AMP5 cartridges.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-357-2014·2013-12-25

    Tween Brands Recalls Peach Anti-Bac Hand Sanitizer Due to Label Error

    Tween Brands Inc is recalling 23,231 bottles of Peach anti-bac hand sanitizer because the label incorrectly states the ethyl alcohol content is 62% instead of the actual 20%.

    Product
    I love to shop Justice, Peach anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-361-2014·2013-12-25

    Tween Brands Recalls Cotton Candy Scented Hand Sanitizer Due to Labeling Error

    Tween Brands Inc is recalling 20,167 bottles of 'I MUSTACHE YOU TO BE MY BFF' hand sanitizer because the label incorrectly states the ethyl alcohol content is 62% instead of the actual 20%.

    Product
    I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-356-2014·2013-12-25

    Tween Brands Recalls Grape Anti-Bac Hand Sanitizer Due to Label Error

    Tween Brands Inc is recalling 21,201 bottles of I love sleep overs Justice, Grape anti bac hand sanitizer because the label incorrectly states the ethyl alcohol content is 62% instead of 20%.

    Product
    I love sleep overs Justice, Grape anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0488-2014·2013-12-25

    Nephros SafeShower and SafeSpout Water Filters Recalled for Marketing Violations

    Nephros Inc. is recalling SafeShower and SafeSpout water filters because promotional materials marketed them as medical devices.

    Product
    1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeSho
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-355-2014·2013-12-25

    Tween Brands Recalls Watermelon Hand Sanitizer Due to Label Error

    Tween Brands Inc is recalling 47,051 bottles of 'I love my BFF Justice' Watermelon anti-bac hand sanitizer because the label incorrectly states the ethyl alcohol content is 62% when it is actually 20%.

    Product
    I love my BFF Justice, Watermelon anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0819-2014·2013-12-18

    Cakes & More Delight's Recalls Sugar-Free Vanilla Cakes for Missing Warning

    Cakes & More Delight's is recalling sugar-free vanilla cakes because they contain aspartame but lack the required phenylketonuria warning.

    Product
    Sugar free cake: Vanilla flavor. Package size: 4 oz, 12 oz; Sliced Sugar-free cake: Vanilla flavor 16 oz.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-347-2014·2013-12-18

    Taro Recalls Subpotent Ciclopirox Shampoo 1% Prescription Bottles

    Taro Pharmaceuticals is recalling 850 bottles of Ciclopirox Shampoo 1% because the product is subpotent. The recall is voluntary and nationwide.

    Product
    CICLOPIROX — CICLOPIROX (CICLOPIROX)
    Category
    Drug
    Distribution
    Distributed nationwide