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.

2101–2125 of 2769

  • LowFDA (Devices)·Z-0208-2015·2014-11-19

    CooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date

    CooperSurgical is recalling 6 units of MILEX Pessary Kits due to incorrect expiration dates printed on the packaging.

    Product
    CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary
    Category
    Medical Device
    Distribution
    13 states
  • LowFDA (Drugs)·D-0246-2015·2014-11-19

    Micro Labs Recalls Simvastatin Tablets Due to Impurity Specification Failure

    Micro Labs USA Inc. is recalling 1,008 bottles of Simvastatin Tablets, 10 mg, because the product failed impurity content specifications.

    Product
    Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-0212-2015·2014-11-19

    Siemens IMMULITE Calcitonin Control Module Recalled for Typographical Error

    Siemens Healthcare Diagnostics is recalling the IMMULITE Calcitonin Control Module due to a typographical error in the expiration date on the instructions for use.

    Product
    IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems Analyzers  for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-0207-2015·2014-11-19

    CooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date

    CooperSurgical is recalling 17 MILEX Pessary Kits because the packaging displays an incorrect expiration date.

    Product
    CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary inc
    Category
    Medical Device
    Distribution
    13 states
  • LowFDA (Drugs)·D-0239-2015·2014-11-12

    Physicians Total Care Recalls Loratadine Tablets Due to Chipped or Broken Pieces

    Physicians Total Care is recalling specific lots of Loratadine 24 HR-OTC 10 mg tablets because they may contain chipped or broken pieces.

    Product
    Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0242-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling specific lots of Candesartan Cilexetil Tablets because they failed impurity and degradation specifications.

    Product
    Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0244-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 32 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0235-2015·2014-11-12

    Pfizer Recalls TORISEL Kits Due to Diluent Crystallization

    Pfizer is recalling 16,000 TORISEL kits because impurities in the diluent may cause crystals to form after cold storage. The TORISEL drug vials are not affected.

    Product
    TORISEL — TORISEL (TEMSIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0238-2015·2014-11-12

    Nanophase Recalls Z-COTE HP 1 Zinc Oxide Powder Due to Manufacturing Error

    Nanophase Technologies is recalling Z-COTE HP 1 Transparent Zinc Oxide powder because an incorrect amount of raw material was added during manufacturing.

    Product
    Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET: 22 KG, Packaged in double plastic liners in a single fiber carton, FOR MANUFACTURING, PROCESSING OR REPACKING, BASF Corporation, Florham Park, NJ
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0243-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 16 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0051-2015·2014-11-05

    Valeant Recalls APLENZIN Tablets Due to Missing Package Insert

    Valeant Pharmaceuticals is recalling 20,499 bottles of APLENZIN (bupropion hydrobromide) 174 mg tablets because the package insert is incorrect or missing.

    Product
    APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0138-2015·2014-11-05

    Coloplast Recalls Mislabeled Biatain Super Non-Adhesive Wound Dressing Lot

    Coloplast is recalling one lot of Biatain Super Non-Adhesive wound dressings due to mislabeling. The affected units were distributed to Missouri and Rhode Island.

    Product
    Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used through
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-0053-2015·2014-11-05

    Valeant Recalls APLENZIN Tablets Due to Missing Package Insert

    Valeant Pharmaceuticals is recalling APLENZIN (bupropion hydrobromide) extended-release tablets because the package insert is incorrect or missing.

    Product
    APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0080-2015·2014-11-05

    Keystone Laboratories Recalls Long Aid Curl Activator Gel Due to Cloudy Appearance

    Keystone Laboratories is recalling Long Aid Curl Activator Gel because the product has a cloudy appearance. The recall covers 39,498 units distributed to several US states and the Bahamas.

    Product
    LONG AID Curl Activator Gel, NET WT. 16.4 OZ. (464.9g), KEYSTONE LABORATORIES, 1103 KANSAS STREET, MEMPHIS, TN 38106, UPC 070596003655
    Category
    Consumer Product
    Distribution
    10 states
  • LowFDA (Drugs)·D-0052-2015·2014-11-05

    Valeant Recalls APLENZIN Tablets Due to Missing Package Insert

    Valeant Pharmaceuticals is recalling APLENZIN extended-release tablets because the package insert is incorrect or missing. Consumers should contact their healthcare provider.

    Product
    APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE bottle (NDC 0024-5811-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0079-2015·2014-10-29

    Wild'erb Herbal Tea Recalled for Potential Illegal Sassafras Ingredient

    Ohio Valley Herbal Products is recalling Wild'erb Herbal Tea because it may contain sassafras leaves, an ingredient deemed illegal by the Ohio Department of Agriculture.

    Product
    Wild'erb Herbal Tea 1.2 oz. and 4 oz. paper bags, tea contained less than 5% sassafras leaves.
    Category
    Food
    Distribution
    6 states
  • LowFDA (Drugs)·D-0043-2015·2014-10-29

    American Health Packaging Recalls Subpotent Methylprednisolone Tablets

    American Health Packaging is recalling 2,005 cartons of Methylprednisolone 4 mg tablets because they failed to meet potency standards at a 6-month stability time point.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0076-2015·2014-10-22

    Arrow International Recalls Central Venous Catheter Kits Due to Labeling Error

    Arrow International is recalling 65 Multi-Lumen Central Venous Catheterization Kits because the outer shipping box displays an incorrect expiration date. The kits inside are correctly labeled and pose no risk to patients.

    Product
    Multi-Lumen Central Venous Catheterization Kit
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Drugs)·D-0019-2015·2014-10-22

    Valeant Recalls Vasotec Tablets Due to Incorrect Package Insert Labeling

    Valeant Pharmaceuticals is recalling 205,853 bottles of Vasotec (enalapril maleate) tablets because they were packaged with the incorrect version of the package insert.

    Product
    VASOTEC — VASOTEC (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0018-2015·2014-10-22

    Vaseretic Tablets Recalled for Incorrect Package Insert Version

    Valeant Pharmaceuticals is recalling Vaseretic tablets because they were packaged with the incorrect version of the package insert.

    Product
    VASERETIC — VASERETIC (ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0013-2015·2014-10-15

    Gilead Recalls Truvada Tablets Due to Silicone Rubber Particulates

    Gilead Sciences is recalling Truvada tablets because they contain small red silicone rubber particulates. The recall affects 10,317 bottles distributed nationwide.

    Product
    TRUVADA — TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0015-2015·2014-10-15

    Richard-Allan Scientific Recalls Bio-Tite Specimen Containers Due to Concentration Issues

    Richard-Allan Scientific is recalling Bio-Tite Specimen Containers because the NBF concentration may be outside specifications.

    Product
    Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0013-2015·2014-10-15

    Richard-Allan Scientific Recalls Specimen Transportation System Due to Concentration Issues

    Richard-Allan Scientific is recalling 285 cases of its Specimen Transportation System because the NBF concentrations may not meet specifications.

    Product
    Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide