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.

1326–1350 of 2769

  • LowFDA (Drugs)·D-0678-2017·2017-05-03

    Novartis Recalls Isopto Carpine Eye Drops for Impurity Failures

    Novartis Pharmaceuticals is recalling specific lots of Isopto Carpine eye drops due to failed impurities and degradation specifications.

    Product
    Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0675-2017·2017-04-26

    InnovaGel Recalls Subpotent Dye Free Allergy Softgel Gelatin Capsules

    InnovaGel is voluntarily recalling Dye Free Allergy Softgel Gelatin Capsules because they are subpotent. The affected product was distributed in New York.

    Product
    Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0067P, NDC 6897080284
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0673-2017·2017-04-26

    Valeant Recalls CLENZIderm M.D. Acne Treatment Kits Due to Discoloration

    Valeant Pharmaceuticals is voluntarily recalling 5,647 units of CLENZIderm M.D. Acne Treatment Systems nationwide due to product discoloration.

    Product
    CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals No
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0672-2017·2017-04-26

    Valeant Recalls CLENZIderm M.D. Pore Therapy Salicylic Acid Acne Treatment

    Valeant Pharmaceuticals is voluntarily recalling CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment due to discoloration.

    Product
    CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0669-2017·2017-04-19

    Jubilant Cadista Recalls Bupropion Hydrochloride Tablets for Impurity Issues

    Jubilant Cadista Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets due to high levels of a degradation product.

    Product
    BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmace
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1767-2017·2017-04-19

    Smiths Medical CADD Administration Set Recalled for Incorrect Filter Size Illustration

    Smiths Medical is recalling CADD Administration Sets because the illustration on the Instructions for Use incorrectly depicts the filter size as 2.0 microns instead of the actual 0.2 microns.

    Product
    CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
    Category
    Medical Device
    Distribution
    43 states
  • LowFDA (Drugs)·D-0671-2017·2017-04-19

    Jubilant Cadista Recalls Bupropion Hydrochloride Tablets for Impurity Failure

    Jubilant Cadista Pharmaceuticals is recalling Bupropion Hydrochloride Extended-release Tablets because high levels of a degradation product were detected.

    Product
    BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmace
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0651-2017·2017-04-19

    West-Ward Recalls Doxercalciferol Capsules Due to Illegible Print

    West-Ward Columbus, Inc. is recalling Doxercalciferol Capsules 0.5mcg because capsules were found with illegible print during an internal inspection.

    Product
    Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla Limited Kurkumbh, Maharashtra, India, Manufactured for West-Ward, Pharmaceuticals, Corp., Eatontown, NJ -- NDC 0054-0338-19
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1720-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Norwegian SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0649-2017·2017-04-12

    Dr. Reddy's Recalls Rivastigmine Tartrate Capsules Due to Cross-Contamination

    Dr. Reddy's is recalling Rivastigmine Tartrate Capsules because testing detected a peak for Ranitidine, indicating cross-contamination with other products.

    Product
    RIVASTIGMINE TARTRATE — RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0636-2017·2017-04-12

    G & W Laboratories Recalls Ciclopirox Olamine Cream Due to Outdated Insert

    G & W Laboratories is recalling 230,700 tubes of Ciclopirox Olamine Cream because some lots were packaged with an out-of-date package insert.

    Product
    CICLOPIROX OLAMINE — CICLOPIROX OLAMINE (CICLOPIROX OLAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1725-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Korean SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0630-2017·2017-04-12

    Alvogen Recalls Nifedipine Extended-Release Tablets Due to Cross-Contamination

    Alvogen, Inc. is recalling Nifedipine Extended-Release Tablets, 60 mg, due to cross-contamination with sorafenib powder found in the manufacturing facility's inlet air duct.

    Product
    Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0633-2017·2017-04-12

    Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination

    Alvogen is recalling specific lots of Adalat CC (nifedipine) extended-release tablets due to cross-contamination with sorafenib powder.

    Product
    Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0623-2017·2017-04-05

    Hetero USA Recalls Montelukast Sodium Tablets Due to Discoloration

    Hetero USA Inc. is recalling 65,664 bottles of Montelukast sodium tablets due to a complaint of blue spots and powder inside a sealed bottle.

    Product
    MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1685-2017·2017-04-05

    Focus Diagnostics Legionella IFA Recalled for Regulatory Status Error

    Focus Diagnostics is recalling Legionella IFA devices because the company discovered the product is not 510(k) exempt. The recall affects 196 units distributed to three testing laboratories.

    Product
    Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1698-2017·2017-04-05

    AGFA DX-D100 X-Ray System Recalled for Missing Allen Wrench Storage Instructions

    AGFA Healthcare Corp. is recalling 308 DX-D100 Digital Radiography X-Ray Systems because the user manual did not specify where to store the Allen wrench used for manual movement.

    Product
    AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
    Category
    Medical Device
    Distribution
    35 states
  • LowFDA (Food)·F-1738-2017·2017-04-05

    Give and Go Mini Pecan Tarts Recalled for Dried Weevil Larvae

    Give and Go Prepared Foods is recalling Mini Pecan Tarts because dried weevil larvae may be present in the product.

    Product
    The Bakery Mini Pecan Tarts Part Platter NET WT 16x 16.2 OZ (460g) item number 08535
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1735-2017·2017-04-05

    Give and Go Recalls Pecan Tarts Due to Potential Weevil Larvae

    Give and Go Prepared Foods is recalling specific pecan tart products because dried weevil larvae may be present.

    Product
    Two-Bite Pecan Tart 9.2 oz (261g) item number 02023; NL Two-Bite Pecan Tarts 24 x 9.2 oz (261g) item number 02046; Sweet P's Bake Shop Pecan Tarts NET WT 9.2 oz (261g) item number 13076
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1634-2017·2017-03-29

    Jugos La Morovena Fruit Punch Recalled for Missing Phenylalanine Warning

    Jugos y Agua La Morovena Inc. is recalling 100 gallons of Fruit Punch juice because the labels lack the required phenylalanine warning for individuals with phenylketonuria.

    Product
    Jugos La Morove¿a, Fruit Punch,Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0607-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling Quillivant XR extended-release oral suspension because it failed to meet dissolution specifications at 12 months. The recall affects 28,938 units distributed nationwide.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-19
    Category
    Drug
    Distribution
    Distributed nationwide