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.

2451–2475 of 2769

  • LowFDA (Drugs)·D-574-2013·2013-06-12

    Novartis Recalls Target Up & Up Athlete's Foot Cream for Labeling Issues

    Novartis is recalling Target Up & Up athlete's foot cream because the lot and expiration dates on the tubes may not be legible.

    Product
    Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-577-2013·2013-06-12

    Novartis Recalls Voltaren Gel Due to Illegible Lot and Expiration Dates

    Novartis Consumer Health is recalling Voltaren Gel because lot and expiration dates on the tubes may be illegible. The FDA classifies this as a Class III recall.

    Product
    Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1504-2013·2013-06-12

    Golden Flower Dried Ginger Recalled for Agriculture Law Violations

    Prosperity Resources International is recalling Golden Flower Dried Ginger in New York State due to violations of the Agriculture and Markets Law.

    Product
    Golden Flower Dried Ginger Net Wt. 6 oz (170g). Packed By: S&Y Co., LTD. No 12 Yuenjiang Road, Gaoming City Guangdong, China. Distributed by: Prosperity Resources Int'l., Inc. USA. Product of China.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-573-2013·2013-06-12

    Novartis Lamisil AT Cream Recalled for Illegible Lot and Expiration Dates

    Novartis is recalling Lamisil AT Cream because the lot and expiration dates on the tubes may be illegible. The recall covers 12-gm and 30-gm tubes distributed nationwide, in Puerto Rico, and in Panama.

    Product
    Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC c
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1478-2013·2013-06-12

    Bion Enterprises IgM Conjugate Recalled for Incorrect Expiration Date Labeling

    Bion Enterprises is recalling 201 units of IgM Conjugate because the labeled expiration date is one year too long.

    Product
    Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-498-2013·2013-06-05

    Aurobindo Recalls Lisinopril Tablets Due to Labeling Error

    Aurobindo Pharma USA Inc is recalling specific lots of Lisinopril 30 mg tablets because the label displays the incorrect strength on the side panel.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1455-2013·2013-06-05

    Meijer Fruit Cups Recalled for Nutrition Labeling Errors

    Meijer Distribution is recalling diced pears, peaches, and mandarin oranges in fruit juice 8 oz cups because the nutrition facts panel reflects the wrong serving size.

    Product
    Meijer Diced Peaches in Fruit Juice 8oz cup
    Category
    Food
    Distribution
    5 states
  • LowFDA (Food)·F-1454-2013·2013-06-05

    Meijer Diced Pears Recalled for Nutrition Labeling Error

    Meijer Distribution is recalling Diced Pears in Fruit Juice 8oz cups because the nutrition facts label reflects the wrong serving size.

    Product
    Meijer Diced Pears in Fruit Juice 8oz cup
    Category
    Food
    Distribution
    5 states
  • LowFDA (Devices)·Z-1429-2013·2013-06-05

    Intuitive Surgical da Vinci Si Surgeon Console Labeling Clarification

    Intuitive Surgical is clarifying labeling and operating procedures for the da Vinci Si Surgeon Console to ensure accurate control of endoscopic instruments.

    Product
    da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1412-2013·2013-06-05

    Spinal Solutions Recalls 40 mm Rods Due to Missing Surgical Instructions

    Spinal Solutions is recalling 63 units of 40 mm Rods because directions for use and surgical techniques were not provided to every physician.

    Product
    40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has cr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1381-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Documentation Issues

    Orthopedic Alliance LLC is recalling 30 units of loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated, ¿48mm U2 Acetabular cup, Ti beads porous coated, ¿50mm U2 Acetabular cup, Ti beads porous coated, ¿52mm U2 Acetabular cup, Ti beads po
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1456-2013·2013-06-05

    Meijer Fruit Cups Recalled for Nutrition Labeling Errors

    Meijer Distribution is recalling specific fruit cups because the serving size was updated but the nutrition facts were not.

    Product
    Meijer Mandarin Oranges in Fruit Juice 8oz cup
    Category
    Food
    Distribution
    5 states
  • LowFDA (Devices)·Z-1426-2013·2013-06-05

    Intuitive Surgical Recalls Unapproved da Vinci Thyroidectomy Promotional Literature

    Intuitive Surgical is recalling promotional literature for the da Vinci Surgical System's thyroidectomy indication because the use was not approved with a 510(k) change.

    Product
    Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (op
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1344-2013·2013-05-29

    Alere Recalls Cardinal Health hCG Cassette Rapid Test Due to Packaging Error

    Alere San Diego is recalling 2,167 Cardinal Health hCG Cassette Rapid Test kits because they were incorrectly packaged in boxes for a different test type.

    Product
    Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-419-2013·2013-05-29

    Rite Aid Tussin Cough Syrup Recalled for Precipitate Presence

    Aaron Industries is recalling Rite Aid brand Tussin Cough & Cold Mucus Relief CF due to the presence of white precipitate, identified as the active ingredient guaifenesin.

    Product
    Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-420-2013·2013-05-29

    Novartis Recalls Lamisil AT Antifungal Cream Due to Illegible Labeling

    Novartis Consumer Health is recalling 3,828 tubes of Lamisil AT antifungal cream because the lot and expiration dates may be illegible.

    Product
    Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1337-2013·2013-05-29

    Ortho-Clinical Diagnostics Recalls VITROS CK-MB Calibrators Due to Invalid Results

    Ortho-Clinical Diagnostics is recalling VITROS CK-MB Calibrators because internal testing found that improperly stored units generated invalid calibrations.

    Product
    VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-452-2013·2013-05-29

    Mylan Recalls Budesonide Capsules Due to Dissolution Testing Failures

    Mylan Institutional, Inc. is recalling 1,621 boxes of Budesonide Capsules, 3 mg, because routine stability testing showed out-of-specification dissolution results.

    Product
    Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, ND
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1179-2013·2013-05-29

    Chicago X-Ray Systems Recalls IntraOs 70 X-Ray Systems for Labeling Defects

    Chicago X-Ray Systems is recalling 1,960 IntraOs 70 intra-oral x-ray systems because they have missing or incomplete labels and user manual information.

    Product
    Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1303-2013·2013-05-22

    Curity I.V. Start Kit Recalled Due to Supplier Component Issue

    Covidien is recalling Curity I.V. Start Kits because a supplier recalled a povidone-iodine applicator used in the kits.

    Product
    Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1331-2013·2013-05-22

    DePuy LifeLiner Gloves Recalled for Mispackaging

    DePuy Orthopaedics is recalling LifeLiner Stick and Cut Resistant Gloves because right-handed packages contained left-handed gloves.

    Product
    DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1336-2013·2013-05-22

    ACUVUE ADVANCE Contact Lenses Recalled for Incomplete Sealing

    Johnson & Johnson Vision Care is recalling ACUVUE ADVANCE contact lenses because a limited number of packages may not have been completely sealed.

    Product
    ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1392-2013·2013-05-22

    Juice Bar Solutions Recalls Add a Scoop Probiotic Due to Labeling Error

    Juice Bar Solutions is recalling 26 containers of Add a Scoop Probiotic because the label claimed the product was GMO-free, but manufacturer paperwork did not support this claim.

    Product
    Add a Scoop by Smoothie Essentials; Probiotic; Supports Digestive Health, dietary supplement; Net Weight: 1 lb (464g) 16 oz. Contains Bacillus Coagulans GBI-30-6086 in a base of Maltdextrin. Gluten Free, GMO Free Manufactured for: Juice Bar Solutions, 38 Maybeck St., Novato
    Category
    Food
    Distribution
    10 states