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.

2376–2400 of 2769

  • LowFDA (Drugs)·D-910-2013·2013-08-28

    Novartis Recalls Maalox Nighttime Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Nighttime Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-908-2013·2013-08-28

    Novartis Recalls Maalox Extra Strength Antacid Due to Illegible Labeling

    Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the packaging.

    Product
    Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-907-2013·2013-08-28

    Novartis Recalls Maalox Antacid Tablets Due to Illegible Labeling

    Novartis Consumer Health is recalling Maalox Regular Strength Antacid chewable tablets because the lot number and expiration date may be illegible on the packaging.

    Product
    Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290, UPC 0 58478 44824 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-905-2013·2013-08-28

    Novartis Recalls Maalox Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets because the lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c) 90-count
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-900-2013·2013-08-28

    Stayma Recalls Subpotent Nata Komplete Multi-Vitamin Tablets

    Stayma Consulting Service is recalling specific lots of Nata Komplete multi-vitamin tablets because they contain subpotent levels of beta carotene (Vitamin A).

    Product
    Nata Komplete, containing one 30-count bottle of multi-vitamin tablets (imprinted 909), Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-909-30) and physician samples of nine bottles of 5-multi-vitamin tablets (NDC 76331-909-05 )
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-906-2013·2013-08-28

    Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling c
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-914-2013·2013-08-28

    Bracco Recalls Tagitol V Barium Sulfate Suspension Due to Stability Failure

    Bracco Diagnostics Inc is recalling Tagitol V Barium Sulfate Suspension Lot #65846 because samples failed viscosity specifications.

    Product
    Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-899-2013·2013-08-28

    Duet DHA 430 ec Recalled for Subpotent Beta Carotene

    Stayma Consulting Service is recalling Duet DHA 430 ec because the beta carotene (Vitamin A) content is subpotent.

    Product
    Duet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-810-30)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1990-2013·2013-08-28

    ConvaTec Flexi-Seal Fecal Management System Recalled for Packaging Error

    Convatec is recalling Flexi-Seal Signal Fecal Management Systems because the lot number convention was duplicated on the packaging for certain lots.

    Product
    ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-909-2013·2013-08-28

    Novartis Recalls Maalox Nighttime Antacid Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Maalox Nighttime Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-904-2013·2013-08-28

    Novartis Recalls Maalox Antacid Tablets Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle.

    Product
    Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3 0067-0376-6
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-903-2013·2013-08-28

    Novartis Recalls Maalox Antacid Tablets Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Maalox Regular Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc., Miss
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1964-2013·2013-08-28

    Philips MobileDiagnost wDR Recalled for Non-Compliant Instructions for Use

    Philips Healthcare is recalling MobileDiagnost wDR systems because the Instructions for Use fail to comply with a Federal standard regarding generator value tolerance levels.

    Product
    Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-895-2013·2013-08-28

    FDA Recalls Duet DHA 400 for Subpotent Beta Carotene

    Stayma Consulting Service is recalling Duet DHA 400 multi-vitamin and Omega-3 products because they contain subpotent levels of beta carotene (Vitamin A).

    Product
    Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-807-30) --- Also Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 763
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-897-2013·2013-08-28

    Stayma Recalls Subpotent NataChew Multi-Vitamin Tablets

    Stayma Consulting Service is recalling specific lots of NataChew multi-vitamin tablets because they contain subpotent levels of beta carotene (Vitamin A).

    Product
    NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and 2) physician samples containing nine bottles with 5 multi-vitamin tablets (imprinted 902) (NDC 44118-902-05), Manufactured for Eckson Labs, Wilmington, DE
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-901-2013·2013-08-28

    AbbVie Recalls Mavik Trandolapril Tablets Due to Outdated Package Insert

    AbbVie is recalling 704 bottles of Mavik trandolapril tablets 4mg because they were packaged with an outdated version of the package insert.

    Product
    Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1991-2013·2013-08-28

    ConvaTec Flexi-Seal Signal Plus Recalled for Packaging Labeling Error

    Convatec Inc. is recalling 22,896 units of Flexi-Seal Signal Plus due to a manufacturing irregularity where lot numbers were duplicated on the packaging.

    Product
    ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-902-2013·2013-08-28

    Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Extra Strength Antacid with Anti-Gas chewable tablets because the lot number and expiration date may be illegible on the packaging.

    Product
    Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1970-2013·2013-08-21

    Siemens ADVIA Centaur Calibrator A Recalled for T4 Assay Inaccuracy

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator A lots due to under-recovery in the Total T4 assay, which may affect calibration accuracy.

    Product
    ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1962-2013·2013-08-21

    Remel Flu A&B Control Swabs Recalled for Incorrect Quality Control Results

    Remel Inc is recalling Flu A&B Control Swabs because they may provide incorrect negative results for Flu A, potentially compromising quality control testing.

    Product
    Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-888-2013·2013-08-21

    Hi-Tech Pharmacal Recalls Clobetasol Propionate Cream Due to Labeling Error

    Hi-Tech Pharmacal is recalling Clobetasol Propionate Cream because some cartons contain tubes with gel labels. The actual product inside is the correct cream.

    Product
    Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-892-2013·2013-08-21

    American Health Packaging Recalls bupropion Hydrochloride Extended Release Tablets

    American Health Packaging is recalling bupropion hydrochloride extended-release tablets due to failed stability specifications for color, dissolution, and related compounds.

    Product
    buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-839-2013·2013-08-14

    West-Ward Recalls Ethambutol Hydrochloride Tablets Due to Surface Ink Defects

    West-Ward Pharmaceutical Corp. is recalling 118 bottles of Ethambutol Hydrochloride Tablets 400 mg due to out-of-specification surface ink defects.

    Product
    VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,
    Category
    Drug
    Distribution
    1 state