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.

1151–1175 of 2769

  • LowFDA (Drugs)·D-0110-2018·2017-12-27

    Osmotica Recalls Subpotent Methylphenidate Hydrochloride Extended-Release Tablets

    Osmotica Pharmaceutical Corp is voluntarily recalling 10,064 bottles of subpotent Methylphenidate Hydrochloride Extended-Release Tablets nationwide.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0108-2018·2017-12-20

    Teva Recalls Penicillin V Potassium Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling specific bottles of Penicillin V Potassium oral solution because they failed impurity and degradation specifications.

    Product
    PENICILLIN V POTASSIUM — PENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0198-2018·2017-12-13

    BD Phoenix AP Instrument Recalled for Potential Robot Arm Movement

    Becton Dickinson & Co. is recalling seven BD Phoenix AP instruments due to a potential for unexpected robot arm movement.

    Product
    BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-0590-2018·2017-12-13

    C.R. Bard Recalls Arctic Sun ArcticGel Pads Due to Labeling Error

    C.R. Bard is recalling 128 units of Arctic Sun ArcticGel Pads - Medium because the product box displays an incorrect reference number.

    Product
    Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-0432-2018·2017-12-06

    Ian's Gluten Free Italian Breadcrumbs Recalled for Potential Beetle Exposure

    Elevation Brands is recalling Ian's Gluten Free Italian Breadcrumbs because raw materials may have been exposed to beetles. No insects were found in the finished product.

    Product
    Ian's Gluten Free Italian Breadcrumbs, UPC# 7-49512-77660-6
    Category
    Food
    Distribution
    6 states
  • LowFDA (Food)·F-0388-2018·2017-12-06

    Maple Hill Creamery Recalls Fresh Mozzarella Due to Visible Spoilage

    Maple Hill Creamery is recalling Fiore Di Latte Fresh Mozzarella because the product showed visible spoilage before the end of its shelf life.

    Product
    Maple Hill Creamery, Fiore Di Latte Fresh Mozzarella; 8-oz. (227g); UPC: 855088005474
    Category
    Food
    Distribution
    3 states
  • LowFDA (Drugs)·D-0094-2018·2017-11-29

    West-Ward Recalls Dexamethasone Sodium Phosphate Injection Due to Impurity

    West-Ward Pharmaceuticals is recalling Dexamethasone Sodium Phosphate Injection due to high levels of a related compound impurity.

    Product
    DEXAMETHASONE SODIUM PHOSPHATE — DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0093-2018·2017-11-29

    West-Ward Recalls Dexamethasone Sodium Phosphate Injection Due to Impurities

    West-Ward Pharmaceuticals is recalling specific lots of Dexamethasone Sodium Phosphate Injection because of high out-of-specification results for a related compound.

    Product
    DEXAMETHASONE SODIUM PHOSPHATE — DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0095-2018·2017-11-22

    Arthrex iBalance UKA Knee Implant Recalled for Incorrect Patient Labeling

    Arthrex is recalling 20 units of iBalance UKA knee implants due to incorrect part numbers and sizes printed on the patient label.

    Product
    iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from p
    Category
    Medical Device
    Distribution
    12 states
  • LowFDA (Drugs)·D-0074-2018·2017-11-22

    Amerisource Recalls Enalapril Maleate Tablets Due to Stability Failures

    Amerisource Health Services is recalling Enalapril Maleate Tablets, 5 mg, because the product failed stability specifications.

    Product
    Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0077-2018·2017-11-22

    Allergan Recalls Combigan Eye Drops Due to Failed Impurity Specifications

    Allergan is recalling 715,041 bottles of Combigan ophthalmic solution because the product failed impurities and degradation specifications.

    Product
    COMBIGAN — COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0075-2018·2017-11-22

    Genzyme Recalls Clolar Injection Due to Missing Package Insert

    Genzyme Corporation is recalling Clolar (clofarabine) injection vials because the package insert is incorrect or missing.

    Product
    Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0130-2018·2017-11-15

    San Gennaro Foods Recalls Frieda's Variety Pack Due to Ink Contact

    San Gennaro Foods is recalling Frieda's Variety Pack pasta sauces because date coding ink was printed on the food contact surface of the packaging.

    Product
    Variety Pack Organic, Pre-cooked just heat & serve, 12/16oz packages, UPC# 0-37842-04159-5 Includes 3 retail units each of Frieda's brand: Sun-Dried Tomato & Garlic, Basil & Garlic, Green Chili & Cilantro, Mushroom & Onion
    Category
    Food
    Distribution
    18 states
  • LowFDA (Food)·F-0142-2018·2017-11-15

    Blue Line Recalls Deep Dish Dough Due to Plastic Pen Fragments

    Blue Line Food Service Distribution is voluntarily recalling specific batches of Deep Dish pre-mix dough because pieces of plastic pen were found in the product.

    Product
    Deep Dish pre mix dough
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0072-2018·2017-11-15

    Doan's Pain Relieving Cream Recalled for Packaging Labeling Mismatch

    Dr. Reddy's is recalling Doan's Pain Relieving Cream because the lot number on the outer packaging does not match the bottle. This is a Class III labeling recall.

    Product
    Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0119-2018·2017-11-15

    San Gennaro Recalls Italian Herb Polenta Due to Unapproved Ink Contact

    San Gennaro Foods is recalling Melissa's Italian Herb Polenta because date coding ink was printed directly on the food contact surface, allowing the unapproved ink to touch the product.

    Product
    Italian Herb Polenta, Melissa's brand, Shelf stable, 12/16 oz packages UPC# 0-45255-11892-6 Ingredients: Water, Organic Cornmeal, Salt, Yeast Extract, Organic Tomato Powder, Organic Onion, Organic Parsley, Organic Oregano, Organic Granulated Onion, Tartaric Acid, Ascorbic Aci
    Category
    Food
    Distribution
    18 states
  • LowFDA (Food)·F-0128-2018·2017-11-15

    San Gennaro Basil Garlic Polenta Recalled for Unapproved Ink Contact

    San Gennaro Foods is recalling Basil Garlic Polenta because date coding ink was printed directly on the food contact surface, allowing the unapproved ink to contact the product.

    Product
    Basil Garlic Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/24 oz packages, UPC# 7-62676-12402-1 Basil Garlic Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/18 oz packages, UPC# 7-62676-15002-0 Basil Garlic Polenta, San Gennaro Canadian
    Category
    Food
    Distribution
    18 states
  • LowFDA (Food)·F-0117-2018·2017-11-15

    Melissa's Sun-Dried Tomato Polenta Recalled for Unapproved Ink Contact

    San Gennaro Foods is recalling Melissa's Sun-Dried Tomato Polenta because date coding ink was printed on the food contact surface, allowing unapproved ink to contact the product.

    Product
    Sun-Dried Tomato Polenta, Melissa's brand, Shelf stable, 12/16 oz package UPC# 0-45255-11848-3 Ingredients: Water, Organic Cornmeal, Organic Sun-Dried Tomatoes, Organic Tomato Powder, Salt, Yeast Extract, Organic Granulated Onion, Tartaric Acid, Ascorbic Acid, Beta Carotene
    Category
    Food
    Distribution
    18 states
  • LowFDA (Food)·F-0126-2018·2017-11-15

    San Gennaro White Polenta Recalled for Unapproved Ink Contact

    San Gennaro Foods is recalling White Polenta because date coding ink was printed directly on the food contact surface, allowing the unapproved ink to touch the product.

    Product
    White Polenta, San Gennaro brand, 12/16oz packages, UPC# 7-62676-17400-2 White Polenta, San Gennaro brand, 6/16oz packages UPC# 7-62676-17400-2 Ingredients: Water, White Corn Meal, Salt, Tartaric Acid
    Category
    Food
    Distribution
    18 states
  • LowFDA (Food)·F-0122-2018·2017-11-15

    Frieda's Mushroom and Onion Organic Polenta Recalled for Unapproved Ink

    San Gennaro Foods is recalling Frieda's Mushroom and Onion Organic Polenta because date coding ink was printed directly on the food contact surface. The ink is not approved for food use.

    Product
    Mushroom and Onion Organic Polenta, Frieda's brand, Pre-cooked just heat & serve, 12/16oz packages, UPC# 0-37842-04155-7 Ingredients: Water, Organic Yellow Corn Meal, Organic Dried Mushrooms (may contain one or more of the following: porcini, chanterelle, shitake, portobello,
    Category
    Food
    Distribution
    18 states
  • LowFDA (Drugs)·D-0056-2018·2017-11-08

    Sanofi Recalls Clofarabine Injection Vials Due to Incorrect Package Insert

    Sanofi-Aventis is recalling 422 vials of Clofarabine injection because the authorized generic product was packaged with the incorrect package insert for the brand name product.

    Product
    Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.
    Category
    Drug
    Distribution
    Distributed nationwide