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.

2726–2750 of 2769

  • LowFDA (Devices)·Z-2030-2012·2012-07-25

    Sigma Recalls Infusion Pump Master Drug Library Editor Software

    Sigma issued a safety alert for the SIGMASpectrum Infusion Pump Master Drug Library Editor software because it may create drug libraries that do not reflect common clinical practices.

    Product
    SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1423-2012·2012-07-25

    Bayer Recalls Midol Complete Due to Labeling Mismatch

    Bayer is recalling 119,412 cartons of Midol Complete because the blister strip label does not match the carton regarding the maximum daily dose.

    Product
    MIDOL COMPLETE — MIDOL COMPLETE (MIDOL COMPLETE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1424-2012·2012-07-25

    Bayer Recalls Midol Complete Due to Labeling Mismatch

    Bayer Healthcare is recalling 48,528 cartons of Midol Complete because the maximum daily dose stated on the blister strip does not match the carton label.

    Product
    MIDOL COMPLETE — MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1411-2012·2012-07-18

    Qualitest Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities

    Vintage Pharmaceuticals is recalling 54,431 bottles of Hydrocortisone and Acetic Acid Otic Solution because impurity levels exceeded specifications.

    Product
    HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1998-2012·2012-07-18

    PSC Industries Recalls Surgical Forceps Due to Labeling Errors

    PSC Industries is recalling 40 units of Model #20-1360K surgical forceps because of typos in the inner packaging labels. The errors did not affect the part or lot numbers.

    Product
    Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords -
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1925-2012·2012-07-18

    Maquet FLOW-i Anesthesia System Recalled for Technical Alarm Issue

    Maquet is recalling 284 FLOW-i Anesthesia Systems because a technical alarm may be generated if the MAN/AUTO switch is not fully engaged.

    Product
    FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1729-2012·2012-07-18

    FDA Recalls Eroxil Tablets Containing Unapproved Synthetic Botanical Ingredients

    H & L Jerch Sales, Inc. is recalling Eroxil tablets nationwide because they contain synthetic equivalents of spermine and/or spermidine, which are not approved for use in dietary supplements.

    Product
    Product Name: Eroxil bottles of 30 tablets taken orally Nokomis Research Inc #6
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1730-2012·2012-07-18

    Erosyn tablets recalled for unapproved synthetic botanical ingredients

    H & L Jerch Sales is recalling Erosyn tablets because they contain synthetic equivalents of botanical constituents that have not been approved for use in dietary supplements.

    Product
    Erosyn bottles of 30 tablets taken orally Nokomis Research Inc Bell Lifestyle Products #7
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1732-2012·2012-07-18

    FDA Recalls Middle-Age Energy Booster Tablets Due to Unapproved Ingredients

    H & L Jerch Sales, Inc. is recalling 1,981 bottles of Middle-Age Energy Booster tablets nationwide because they contain unapproved synthetic botanical ingredients.

    Product
    Middle-Age Energy Booster bottles of 60 tablets taken orally Nokomis Research Inc Bell Lifestyle Products #65
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1996-2012·2012-07-18

    PSC Industries Recalls Bayonet Forceps Due to Incorrect Expiration Date

    PSC Industries is recalling 80 units of Bayonet Forceps because the outer carton lists an incorrect sterile expiration date, though the individual pouch labels are correct.

    Product
    Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Ol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1991-2012·2012-07-18

    PSC Industries Recalls Button Switchpens Due to Labeling Errors

    PSC Industries is recalling Button Switchpens because the packaging labels incorrectly state the devices include a holster. The recall covers 725 units distributed nationwide.

    Product
    Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1994-2012·2012-07-18

    PSC Industries Recalls Bipolar Bayonet Forceps Due to Packaging Labeling Error

    PSC Industries is recalling 7 units of Bipolar Bayonet Forceps because the manufacturer symbol was incorrectly replaced by the expiry symbol on the packaging.

    Product
    Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1990-2012·2012-07-18

    PSC Industries Recalls Button Switch Pen Electrodes Due to Labeling Errors

    PSC Industries is recalling 50 units of Button Switch Pen Electrodes due to a labeling error where the manufacturer symbol replaced the expiration date symbol.

    Product
    Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1404-2012·2012-07-11

    Imodium Multi-Symptom Relief Caplets Recalled for Defective Containers

    McNeil Consumer Healthcare is recalling Imodium Multi-Symptom Relief Caplets due to defective containers and damaged blister units.

    Product
    Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1639-2012·2012-07-11

    Dannon Mixed Berry Yogurt Recalled for Routine Coliform Testing

    The Dannon Company Inc is recalling 1,350 cases of Dannon Fruit on the Bottom Mixed Berry yogurt due to routine testing showing the presence of Coliforms.

    Product
    Dannon Fruit on the Bottom, Mixed Berry flavor. 6oz form fill seal cup yogurt with predominantly blue labelling.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Devices)·Z-1943-2012·2012-07-11

    Integra Recalls Single Shot Epidural Trays Missing Injectable Components

    Integra LifeSciences is recalling one lot of Single Shot Epidural Trays because they were shipped without required injectable components.

    Product
    Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical pro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1399-2012·2012-07-11

    Watson Loxapine Capsules Recalled for Outdated Patient Outsert

    Watson Laboratories is recalling 8,254 bottles of Loxapine Capsules 5mg because an outdated patient outsert was used during packaging.

    Product
    Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1638-2012·2012-07-11

    Dannon Fruit on the Bottom Yogurt Recalled for Coliforms

    The Dannon Company is recalling specific lots of Fruit on the Bottom Raspberry yogurt due to routine testing that detected coliforms.

    Product
    Dannon Fruit on the Bottom, Raspberry flavor. 6oz form fill seal cup yogurt with predominantly blue labelling.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Drugs)·D-1403-2012·2012-07-11

    Watson Recalls Loxapine Succinate Capsules Due to Outdated Patient Outsert

    Watson Laboratories is recalling 7,262 bottles of Loxapine Succinate Capsules because an outdated patient outsert was used during packaging.

    Product
    Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1406-2012·2012-07-11

    Health Plus Super Colon Cleanse Recalled for Labeling Error

    Health Plus Incorporated is recalling Super Colon Cleanse capsules because the Drug Facts label incorrectly describes the active ingredient per dose instead of per capsule.

    Product
    Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1405-2012·2012-07-11

    Ranbaxy Recalls Subpotent Balnetar Therapeutic Tar Bath Coal Tar Product

    Ranbaxy Inc. is recalling Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5%, because the product failed to meet specifications for coal tar content.

    Product
    Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1402-2012·2012-07-11

    Watson Recalls Loxapine Capsules Due to Outdated Patient Outsert

    Watson Laboratories is recalling 18,902 bottles of Loxapine 50mg capsules because an outdated patient outsert was used during packaging.

    Product
    LOXAPINE — LOXAPINE (LOXAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1460-2012·2012-06-27

    FDA Removes Korean Shellfish Shippers from Interstate List

    The FDA removed all Korean certified shippers of molluscan shellfish from the Interstate Shellfish Shippers List because the Korean Shellfish Sanitation Program no longer meets required sanitation controls.

    Product
    Granadaisa whole Oysters, Net WT. 8 oz (225 grams); Packed For King Seafoods Inc. PO BOX 107, Mount Holly, NJ USA 08060 Product of Korea Farm Raised, UPC 719882002049.
    Category
    Food
    Distribution
    3 states