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.

2551–2575 of 2769

  • LowFDA (Drugs)·D-208-2013·2013-03-27

    Novartis Recalls Nupercainal Ointment Due to Illegible Labeling

    Novartis Consumer Health is recalling Nupercainal Ointment because lot numbers and expiration dates may be illegible or missing.

    Product
    Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-210-2013·2013-03-27

    Novartis Recalls Nasal Spray Due to Illegible Lot and Expiration Dates

    Novartis Consumer Health is recalling 4 way Nasal Decongestant Menthol Nasal Spray because lot numbers and expiration dates may be illegible.

    Product
    4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-209-2013·2013-03-27

    Novartis Recalls 4 Way Nasal Spray Due to Illegible Labeling

    Novartis Consumer Health is recalling 4 Way Nasal Spray because lot numbers and expiration dates may be illegible.

    Product
    4 WAY — 4 WAY (PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-207-2013·2013-03-27

    Novartis Recalls Myoflex Cream Due to Illegible Lot and Expiration Dates

    Novartis Consumer Health is recalling Myoflex Pain Relieving Cream because lot numbers and expiration dates may be illegible. The recall covers 2-oz and 4-oz tubes distributed nationwide and in Panama.

    Product
    Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0933-2013·2013-03-20

    Siemens Total Iron Binding Capacity Reagent Cartridge Recall for Labeling Error

    Siemens is recalling Total Iron Binding Capacity reagent cartridges because the stated analytical sensitivity in the instructions is no longer valid.

    Product
    Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1130-2013·2013-03-20

    JMT Trading Recalls Tausi Salted Black Beans Due to Swollen Cans

    JMT Trading Company is recalling Tausi Salted Black Beans from the Philippines after reports of swollen cans. The product was distributed in the CA Bay area and Hawaii.

    Product
    Tausi Salted Black Beans, 180 gram (6.34 oz.) can. Ingredient: Black Beans, Water, Iodized salt, sugar and caramel. Distributed by V8 Commercial Co., Inc., San Juan, Metro Manila. Product of the Philippines. UPC 97399 00109
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-200-2013·2013-03-20

    Fresenius Kabi Recalls Calcium Glucosate Injection Due to Missing Label

    Fresenius Kabi USA LLC is recalling 155,900 vials of Calcium Glucosate Injection, USP, 10% due to missing labels. The recall is nationwide.

    Product
    CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-186-2013·2013-03-13

    Rite Aid Tussin Cough Syrup Recalled for Precipitate Presence

    Aaron Industries is recalling Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF due to the presence of a white precipitate.

    Product
    Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0916-2013·2013-03-13

    Linvatec Recalls D3000 Advantage Drive Systems Due to Incorrect Panel Symbology

    Linvatec Corp. is recalling 31 D3000 Advantage Drive Systems because the front panel contains incorrect symbology, violating IEC60606-01 standards.

    Product
    D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-187-2013·2013-03-13

    Aaron Industries Recalls Select Brand Cough Control CF Max Due to Precipitate

    Aaron Industries Inc is recalling Select Brand Cough Control CF Max bottles due to the presence of a white precipitate, identified as the active ingredient guaifenesin.

    Product
    Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0917-2013·2013-03-13

    ConMed Linvatec Recalls D3000I Surgical Drive Systems Due to Incorrect Symbology

    ConMed Linvatec is recalling 23 D3000I Advantage Drive Systems because the membrane switch panel contains incorrect symbology, violating IEC60606-01 standards.

    Product
    D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0911-2013·2013-03-13

    BD Vacutainer Plus Plasma Separator Tubes Recalled for Deformed Reservoirs

    Becton Dickinson is recalling BD Vacutainer Plus Plasma Separator Tubes due to deformed tube reservoirs reported in two customer complaints.

    Product
    BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for speci
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-182-2013·2013-03-13

    Glenmark Recalls Montelukast Sodium Tablets Due to Chemical Contamination

    Glenmark Generics Inc. is recalling Montelukast Sodium Tablets, 10 mg, due to trace levels of chemical contaminants causing off-odors.

    Product
    Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-189-2013·2013-03-13

    VersaPharm Ethambutol Tablets Recalled for Discoloration

    West-ward Pharmaceutical Corp. is recalling VersaPharm Ethambutol Tablets USP 400 mg because the tablet cores may be discolored.

    Product
    VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11 Manufactured for: VersaPharm Incorporated Marietta, GA
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-185-2013·2013-03-13

    Aaron Industries Recalls Walgreens Wal-Tussin CF Max Due to Precipitate

    Aaron Industries is recalling 6,108 bottles of Walgreens Wal-Tussin CF Max because a white substance, confirmed as the active ingredient guaifenesin, was observed in some bottles.

    Product
    Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-188-2013·2013-03-13

    Aaron Industries Recalls Wal-Mart Equate Tussin CF Due to Precipitate

    Aaron Industries is recalling Wal-Mart Equate Tussin CF bottles containing a white precipitate. The substance is confirmed as guaifenesin, an active ingredient.

    Product
    Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-177-2013·2013-03-06

    Bayer Recalls Bronkaid Dual Action Formula Due to Labeling Errors

    Bayer Healthcare is recalling Bronkaid Dual Action Formula caplets because the carton label is missing a warning or Rx legend and other information.

    Product
    Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0876-2013·2013-03-06

    Ultradent Recalls Mislabelled Avex CX Orthodontic Brackets

    Ultradent Products, Inc. is recalling 124 units of Avex CX orthodontic brackets due to incorrect labeling. The affected products were distributed nationwide in the US.

    Product
    Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-175-2013·2013-03-06

    Actavis Recalls BuPROPion Hydrochloride Tablets Due to Dissolution Failure

    Actavis Pharmaceuticals is recalling 14,856 bottles of buPROPion Hydrochloride Extended-Release Tablets 300 mg because they failed dissolution specifications during stability testing.

    Product
    buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowNHTSA·13V084000·2013-03-05

    Volvo Recalls 2013 S60 and XC60 for Incorrect Certification Labels

    Volvo is recalling 2013 S60 and XC60 vehicles manufactured on January 7, 2013, because their certification labels list the incorrect manufacture year.

    Product
    VOLVO — VOLVO XC60, S60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0825-2013·2013-02-27

    HealthTronics RenalCryo Cryoprobe Recalled for Incorrect Expiration Label

    Healthtronics, Inc. is recalling 50 units of Endocare 3.8mm RenalCryo Cryoprobes because the outer box labels display incorrect expiration dates.

    Product
    HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0811-2013·2013-02-20

    Ultradent Chromaclone PVS Impression Material Recalled for Packaging Error

    Ultradent Products is recalling specific lots of Chromaclone PVS impression material due to incorrect packaging of regular and fast set cartridges.

    Product
    Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
    Category
    Medical Device
    Distribution
    Distributed nationwide