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.

2201–2225 of 2769

  • LowFDA (Food)·F-2040-2014·2014-06-25

    Manischewitz Recalls Tam Tams Snack Crackers Due to Rancidity

    The Manischewitz Company is recalling Tam Tams Snack Crackers Original due to rancidity. The recall covers 29,413 units distributed nationwide.

    Product
    Tam Tams Snack Crackers Original Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1785-2014·2014-06-25

    Convatec Recalls Flexi-Seal Fecal Management System for Regulatory and Performance Issues

    Convatec Inc. is recalling the Flexi-Seal Fecal Management System because it lacks FDA 510(k) clearance and its Auto-Valve feature is not performing consistently.

    Product
    Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2038-2014·2014-06-25

    Manischewitz Recalls Tam Tams Snack Crackers Due to Rancidity

    The Manischewitz Company is recalling Tam Tams Snack Crackers Garlic due to rancidity. The recall covers 29,413 units distributed nationwide.

    Product
    Tam Tams Snack Crackers Garlic Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2036-2014·2014-06-25

    Manischewitz Recalls Tam Tams Snack Crackers Due to Rancidity

    The Manischewitz Company is recalling Tam Tams Snack Crackers Unsalted due to rancidity. The recall covers 29,413 cases distributed nationwide.

    Product
    Tam Tams Snack Crackers Unsalted Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1793-2014·2014-06-25

    Gen-Probe Recalls APTIMA Urine Collection Kits Due to Labeling Error

    Gen-Probe Inc is recalling APTIMA Urine Collection Kits because inner pouches are mislabeled as swab collection kits.

    Product
    APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1787-2014·2014-06-18

    Beekley Spots Light Image O-Spots Recalled for Mislabeled Dispenser

    Beekley Corporation is recalling 81 boxes of Light Image O-Spots for mammography because the dispensers were mislabeled as S-Spots.

    Product
    Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-1731-2014·2014-06-18

    Summit Medical Recalls Mixed Lot of Armstrong Grommet Ventilation Tubes

    Summit Medical, Inc. is recalling one lot of Armstrong Grommet ventilation tubes due to mixed flange types. The agency states this poses no health hazard to users or patients.

    Product
    Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Food)·F-1995-2014·2014-06-11

    American Licorice Company Recalls Redvines Fruit Vines Bites for Labeling Error

    American Licorice Company is recalling Redvines Fruit Vines Bites because the packaging incorrectly lists the sodium content as 35g instead of 35mg.

    Product
    REDVINES FRUIT VINES Bites Strawberry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Facts: ***Sodium 35g***ALLERGEN INFORMATION: CONTAINS WHEAT***AMERICAN LICORICE COMPANY, UNION CITY, CA 94587 UPC 0 41364 82006 4
    Category
    Food
    Distribution
    9 states
  • LowFDA (Food)·F-1994-2014·2014-06-11

    American Licorice Company Recalls Redvines Fruit Vines Bites Due to Labeling Error

    American Licorice Company is recalling Redvines Fruit Vines Bites Cherry because the packaging incorrectly lists sodium content as 35g instead of 35mg.

    Product
    REDVINES FRUIT VINES Bites Cherry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Facts: ***Sodium 35g***ALLERGEN INFORMATION: CONTAINS WHEAT***AMERICAN LICORICE COMPANY, UNION CITY, CA 94587 UPC 0 41364 82001 9
    Category
    Food
    Distribution
    9 states
  • LowFDA (Drugs)·D-1353-2014·2014-06-04

    PediaCare Day & Night Cold Syrup Recalled for Precipitate

    Prestige Brands Holdings is recalling PediaCare Day & Night Cold syrup bottles due to the presence of precipitate.

    Product
    PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1663-2014·2014-06-04

    Siemens Recalls MAGNETOM Aera Systems Due to Missing Operator Manuals

    Siemens is recalling five MAGNETOM Aera magnetic resonance systems because a processing error may have prevented some users from receiving their Operator Manuals.

    Product
    MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or func
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Drugs)·D-1352-2014·2014-06-04

    PediaCare Nighttime Cold Syrup Recalled for Diphenhydramine Precipitate

    Prestige Brands Holdings is recalling PediaCare Nighttime Multi-Symptom Cold syrup due to the presence of diphenhydramine precipitate in the solution.

    Product
    PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·033-2014·2014-05-29

    Boulder Natural Meats Recalls Chicken Breasts Due to Gluten Free Label Error

    Boulder Natural Meats is recalling approximately 363 pounds of boneless skinless chicken breasts because the front label incorrectly stated the product was gluten free, despite containing wheat.

    Product
    Recall Notification Report 033-2014 (Boneless Skinless Chicken Breasts)
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-1347-2014·2014-05-28

    Oasis Tears Lubricant Eye Drops Recalled for Missing Bottle Labels

    Oasis Medical Inc. is recalling 10,549 bottles of Oasis Tears Lubricant Eye Drops because the label on the immediate bottle is missing.

    Product
    Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1315-2014·2014-05-21

    Konsyl Psyllium Fiber Recalled for Inaccurate Labeling of Active Ingredient Strength

    Konsyl Pharmaceuticals is recalling 6,286 bottles of Psyllium Fiber capsules because the label lists an inaccurate strength for the active ingredient.

    Product
    PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.
    Category
    Drug
    Distribution
    9 states
  • LowFDA (Food)·F-1943-2014·2014-05-21

    Gold Medal Recalls Cajun Savory Packed in Hot & Spicy Containers

    Gold Medal Products is recalling 137 containers of Cajun Savory that were packed in Hot & Spicy containers. The recall covers distribution in nine US states and Bermuda.

    Product
    2372 HOT & SPICY; 4 pound plastic gallon containers; UPC 0 9093912372 7
    Category
    Food
    Distribution
    9 states
  • LowFDA (Drugs)·D-1311-2014·2014-05-14

    Merck Recalls Liptruzet Tablets Due to Packaging Defects

    Merck is recalling Liptruzet tablets because outer packaging defects allowed air and moisture to enter, potentially affecting product effectiveness.

    Product
    Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1310-2014·2014-05-14

    Merck Recalls Liptruzet Tablets Due to Packaging Defects

    Merck & Co. is recalling Liptruzet tablets because packaging defects allowed air and moisture to enter, potentially reducing product effectiveness.

    Product
    Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1309-2014·2014-05-14

    Merck Recalls Liptruzet Tablets Due to Packaging Defects

    Merck & Co. is recalling Liptruzet tablets because packaging defects allowed air and moisture to enter, potentially affecting product effectiveness.

    Product
    Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1312-2014·2014-05-14

    Merck Recalls Liptruzet Tablets Due to Defective Outer Packaging

    Merck is recalling Liptruzet tablets because defective outer foil pouches may allow air and moisture to enter, potentially affecting product effectiveness.

    Product
    Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1545-2014·2014-05-14

    Siemens CLINITEK Status+ Analyzer Recalled for Uncleared Marketing Status

    Siemens Healthcare Diagnostics Inc is recalling CLINITEK Status+ Analyzers with Sample Interference Notes enabled because they were not cleared for US marketing.

    Product
    CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1313-2014·2014-05-14

    Boehringer Ingelheim Roxane Recalls Azathioprine Tablets Due to Incorrect Expiration Dates

    Boehringer Ingelheim Roxane Inc is recalling 8,304 bottles of Azathioprine Tablets USP, 50 mg, because they were labeled with 36-month expiration dates instead of the approved 24 months.

    Product
    Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1259-2014·2014-05-07

    John W Hollis Recalls Polidocanol 1% Solution Due to Incorrect Expiration Date

    John W Hollis Inc is recalling 2 vials of Polidocanol 1% Solution because the expiration date on the vial is earlier than the date listed on the label.

    Product
    Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
    Category
    Drug
    Distribution
    4 states
  • LowFDA (Drugs)·D-1286-2014·2014-05-07

    Aaron Industries Recalls Tussin DM Cough Syrup Due to Precipitate

    Aaron Industries is recalling 108,792 bottles of Tussin DM cough syrup because a white substance, identified as the active ingredient Guaifenesin, was observed in some bottles.

    Product
    Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, La
    Category
    Drug
    Distribution
    Distributed nationwide