The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

13201–13225 of 21617

  • ModerateFDA (Food)·F-1358-2017·2017-02-01

    Berner Food & Beverage Recalls Four Cheese Alfredo Pasta Sauce

    Berner Food & Beverage is recalling 850 cases of Four Cheese Alfredo Pasta Sauce due to contamination with spoilage bacteria.

    Product
    Four Cheese Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 70038627838, 36800334793 or 041498198084
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1353-2017·2017-02-01

    IQ Formulations Recalls Pre-Workout Powder Containing Unapproved Ingredients

    IQ Formulations is recalling P.S.P. Pre-Workout powder because it contains picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, green apple (UPC 764779-360344). Brand: Metabolic Nutrition.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1360-2017·2017-02-01

    Berner Food Recalls Our Family Alfredo Pasta Sauce Due to Bacteria

    Berner Food & Beverage, LLC is recalling Our Family Alfredo Pasta Sauce contaminated with spoilage bacteria. Consumers should discard the product.

    Product
    Our Family Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 70253266867
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1100-2017·2017-02-01

    PerkinElmer AutoDELFIA Plate Processor Recalled for Potential Loading Failures

    PerkinElmer is recalling AutoDELFIA Plate Processors with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.

    Product
    AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1057-2017·2017-02-01

    On-X Chord-X Chordal Sizer Recalled for Manufacturing Defects

    On-X Life Technologies is recalling 45 units of the Chord-X Chordal Sizer due to manufacturing defects including burrs, particulate, hair, and assembly errors.

    Product
    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0443-2017·2017-02-01

    Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

    Mylan LLC is recalling Temozolomide Capsules, 180 mg, due to customer complaints of broken or crushed capsules resulting in loose powder in the bottles.

    Product
    Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1352-2017·2017-02-01

    Metabolic Nutrition Pre-Workout Powder Recalled for Unapproved Ingredients

    IQ Formulations is recalling Metabolic Nutrition P.S.P. Pre-Workout powder because it contains Picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, fruit punch (UPC 764779-360238). Brand: Metabolic Nutrition.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1086-2017·2017-02-01

    Atrium Medical Recalls Oasis Blood Recovery Drains Due to Sterility Issues

    Atrium Medical is recalling Oasis Blood Recovery Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.

    Product
    Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 3652-100 Oasis Double Blood Recovery drain with in-line connectors - 2 patient lines connected by one Y connector Product Usage: To evacuate air and/or fluid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0440-2017·2017-02-01

    Teva Recalls Amoxicillin Oral Suspension Due to Low Potency

    Teva Pharmaceuticals is recalling specific lots of Amoxicillin for Oral Suspension because stability testing revealed the medication was below the required potency standard.

    Product
    Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1087-2017·2017-02-01

    Atrium Medical 400 Series Express Drains Recalled for Non-Sterile Packaging

    Atrium Medical is recalling 400 Series Express Drains because the outer packaging is not sterile. The recall affects approximately 1.4 million cases distributed worldwide.

    Product
    Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Express PreFilled Chest Drain 4020-100N Express dual chamber drain with in-line connectors ( 2 Patient Tubes) 4050-100N Express Blood Recovery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0446-2017·2017-02-01

    Sun Pharmaceutical Recalls BuPROPion Hydrochloride Tablets for Dissolution Failures

    Sun Pharmaceutical Industries is recalling 11,618 bottles of buPROPion Hydrochloride Extended-release Tablets due to failed dissolution specifications and stability issues.

    Product
    buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0442-2017·2017-02-01

    Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

    Mylan LLC is recalling Temozolomide Capsules, 140 mg, due to customer complaints of broken or crushed capsules resulting in loose powder in the bottles.

    Product
    Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1072-2017·2017-02-01

    Binding Site IgG Subclass Reagent Kits Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG Subclass Liquid Reagent Kits because high IgG4 levels can cause spuriously low test results.

    Product
    Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1071-2017·2017-02-01

    Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.

    Product
    Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1073-2017·2017-02-01

    Binding Site IgG4 Kit Recalled for Inaccurate Results in High Levels

    The Binding Site Group is recalling MininephThl Human IgG4 Kits because samples with extremely high IgG4 levels may yield spuriously low results.

    Product
    MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-1347-2017·2017-02-01

    IQ Formulations Recalls E.S.P. Pre-Workout Powder for Unapproved Ingredients

    IQ Formulations is recalling E.S.P. Pre-Workout powder because it contains picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, blue raspberry flavor (UPC 764779-410728.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1344-2017·2017-02-01

    Dr. Pepper 2-Liter Bottles Recalled for Potential Undeclared Aspartame

    Coca-Cola Consolidated is recalling 2-liter bottles of Dr. Pepper that may contain Diet Dr. Pepper with undeclared aspartame.

    Product
    Dr. Pepper, 2 Liters (2.1 qt) plastic bottles, Bottled under the authority of Dr. Pepper Company, 5301 Legacy Drive, Plano, TX 75024.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1084-2017·2017-02-01

    Atrium Medical Oasis Pediatric Drain Recalled for Non-Sterile Packaging

    Atrium Medical is recalling Oasis Pediatric Drains because the outer packaging is not sterile. The recall covers 964,463 US cases and 521,975 international cases.

    Product
    Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain 3612-400 Oasis Infant/Pediatric drain with no in-line connector, ¿ in. tubing, Sims and Pedi connector…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0447-2017·2017-02-01

    Cambrex Recalls Mesalamine API Due to Stainless Steel Particulate Matter

    Cambrex Charles City Inc is recalling Mesalamine API due to the presence of stainless steel particulate matter detected in the finished product.

    Product
    Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1088-2017·2017-02-01

    Atrium Medical Express Mini 500 Dry Seal Drain Recall

    Atrium Medical is recalling Express Mini 500 dry seal drains because the outer packaging is not sterile.

    Product
    Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum.  To help re-establish lung expansion and restore breathing dynamics.  To facilitate postoperative collection and reinfusion of autologous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1104-2017·2017-02-01

    Mesa Laboratories Recalls ProSpore Biological Indicators Due to Reduced Resistance

    Mesa Laboratories is recalling ProSpore 4 mL Ampoule Biological Indicators because product resistance fell outside label claims within the expiration date.

    Product
    ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care…
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Food)·F-1331-2017·2017-01-25

    O'Pelle Bakery Egg Bagels Recalled for Missing Yellow 5 Labeling

    O'Pelle Enterprises is recalling frozen raw Egg Bagels because the label fails to declare Yellow 5. The product was distributed only within Florida.

    Product
    Opelle Bakery Egg Bagel (B-105), case of 96 (4 oz.), Frozen Raw.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1031-2017·2017-01-25

    Exactech Recalls Polyethylene Acetabular Liners Due to Incorrect GTIN Labels

    Exactech, Inc. is recalling 12 polyethylene acetabular liners because they were labeled with incorrect Global Trade Item Numbers (GTINs).

    Product
    AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1025-2017·2017-01-25

    Zimmer Biomet Recalls ArComXL Polyethylene Bearings Due to Labeling Mismatch

    Zimmer Biomet is recalling 19 ArComXL Polyethylene Bearings because packaging labels did not match the physical product inside, posing a risk of surgical delay.

    Product
    Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
    Category
    Medical Device
    Distribution
    Distributed nationwide