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.

9051–9075 of 21595

  • ModerateFDA (Drugs)·D-1299-2019·2019-05-22

    DrKids Children's Pain & Fever Oral Solution Recalled for B. cepacia Risk

    Unipharma, LLC is recalling 280 cartons of DrKids Children's Pain & Fever Oral Solution due to potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL), Cherry Flavor, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-011-20, UPC 370302223019
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1367-2019·2019-05-22

    Barlean's Omega Man Softgels Recalled for Undeclared Sulfites

    Barlean's LLC is recalling Omega Man softgels due to undeclared sulfites. Sulfite levels do not exceed 10 ppm.

    Product
    Item FG 10149, Barlean s, Omega Man, 120 Softgels per bottle, UPC 7 05875 10019 9
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1303-2019·2019-05-22

    DrKids Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma is recalling DrKids Children's Natural Cough Syrup due to potential contamination with B. cepacia bacteria. This is a precautionary measure.

    Product
    DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302489019
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1352-2019·2019-05-22

    Back Roads Gluten-Free Granola Recalled for Aluminum Contamination

    Back Roads Food Company is recalling specific lots of Gluten-Free Granola because the products may contain pieces of aluminum.

    Product
    Back Roads Granola: Gluten Free Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1366-2019·2019-05-22

    Barlean's Essential Woman Softgels Recalled for Undeclared Sulfites

    Barlean's is recalling Essential Woman softgels due to undeclared sulfites. Sulfite levels in the finished goods do not exceed 10 ppm.

    Product
    Item FG 10146, Barlean s, Essential Woman, 120 count Softgels per bottle, UPC 7 05875 10013 7. Item FG 10147, Barlean s, Essential Woman, 60 count Softgels per bottle, UPC 7 05875 10009 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1365-2019·2019-05-22

    Barlean's Master Blend Omega 3.6.9 Recalled for Undeclared Sulfites

    Barlean's is recalling Master Blend Total Omega 3.6.9 Lemonade Flavor softgels due to undeclared sulfites. The product was distributed nationwide.

    Product
    Item FG 10116, Barlean s, Master Blend Total Omega 3.6.9 Lemonade Flavor, 90 Softgels per bottle. UPC 7 05875 10020 5.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1362-2019·2019-05-22

    Barlean's Fish Oil Recalled for Undeclared Sulfites

    Barlean's is recalling Ultra EPA-DHA Fish Oil softgels due to undeclared sulfites. Sulfite levels are below 10 ppm.

    Product
    Item FG 10085, Barleans, Ultra EPA-DHA Fish Oil 1,300 mg Omega-3 Orange Flavor, 60 Softgels per bottle. UPC 7 05875 61006 3.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1300-2019·2019-05-22

    CVS Children's Allergy Liquid Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Allergy Relief Liquid Medication due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution Antihistamine Mixed Berry Flavor 20 Single-Use 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-261-01, UPC 050428597156
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1350-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling specific lots of Ancient Grains Granola because the products may contain pieces of aluminum.

    Product
    Back Roads Granola: Ancient Grains Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1297-2019·2019-05-22

    CVS Health Children's Mucus Relief Recalled for B. cepacia Contamination Risk

    Unipharma, LLC is recalling CVS Health Children's Mucus Relief Chest Congestion Plus Cough due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-26
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1357-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling Maple Spice Granola because the product may contain pieces of aluminum.

    Product
    Back Roads Granola: Maple Spice Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1341-2019·2019-05-22

    Siemens Artis Q Angiography Systems Recalled for Tabletop Movement Blockage

    Siemens Medical Solutions is recalling 459 Artis Q angiography systems because the floating tabletop movement may be blocked after a collision sensor activates.

    Product
    Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1304-2019·2019-05-22

    CVS Health Children's Nasal Saline Drops Recalled for B. cepacia Risk

    Unipharma, LLC is recalling CVS Health Children's Nasal Saline Drops due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1355-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling specific lots of Coconut Ginger Granola because the product may contain pieces of aluminum.

    Product
    Back Roads Granola: Coconut Ginger Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1354-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling specific lots of Coconut Crunch Granola because the products may contain pieces of aluminum.

    Product
    Back Roads Granola: Coconut Crunch Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1348-2019·2019-05-22

    MediPress Pneumatic Compression System Recalled for Lack of Clearance

    Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.

    Product
    MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1346-2019·2019-05-22

    MediPress Pneumatic Compression System Recalled for Lack of Clearance

    Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.

    Product
    MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Food)·F-1358-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling specific lots of Nut Free Granola because the product may contain pieces of aluminum.

    Product
    Back Roads Granola: Nut Free Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1368-2019·2019-05-22

    Barlean's Full Spectrum Hemp Extract Recalled for Undeclared Sulfites

    Barlean's is recalling Full Spectrum Hemp Extract softgels due to undeclared sulfites. Sulfite levels do not exceed 10 ppm.

    Product
    Item FG 10190, Barleans Full Spectrum Hemp Extract, 60 Softgels per bottle. UPC 7 05875 80113 3. Item FG 10193, Barleans Full Spectrum Hemp Extract, 30 Softgels per bottle. UPC 7 05875 80115 7.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1359-2019·2019-05-22

    Barlean's Cod Liver Oil Recalled for Undeclared Sulfites

    Barlean's is recalling Cod Liver Oil softgels due to undeclared sulfites. Sulfite levels do not exceed 10 ppm.

    Product
    Item FG 10037, Barlean s Cod Liver Oil Omega 3 EPA/DHA with Added Vitamin D, 100 softgel per bottle. UPC 7 05875 61010 0
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1369-2019·2019-05-22

    Barlean's CBD Hemp Oil Softgels Recalled for Undeclared Sulfites

    Barlean's is recalling two CBD hemp oil softgel products due to undeclared sulfites. Sulfite levels in the finished goods do not exceed 10 ppm.

    Product
    Item FG 10191, Barlean s Ideal CBD Hemp Oil Softgel, 900 mg CBD, Less than 0.3% THC, 60 Softgels per bottle. UPC 7 05875 80112 6. Item FG 10194, Barlean s Ideal CBD Hemp Oil softgel, 750 mg CBD, Less than 0.3% THC, 30 Softgels per bottle. UPC 7 05875 80114 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1301-2019·2019-05-22

    DrKids Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma is recalling DrKids Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1296-2019·2019-05-22

    CVS Children's Acetaminophen Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Pain & Fever Acetaminophen single-use vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1306-2019·2019-05-22

    CVS Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01,
    Category
    Drug
    Distribution
    Distributed nationwide