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.

11576–11600 of 21617

  • ModerateFDA (Drugs)·D-0196-2018·2018-01-17

    KRS Global Biotechnology Recalls Sermorelin Acetate Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 157 vials of Sermorelin Acetate/GHRP6 due to incorrect or missing lot and expiration dates.

    Product
    Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0197-2018·2018-01-17

    KRS Global Biotechnology Recalls Sincalide Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 898 vials of Sincalide 5 mcg due to incorrect or missing lot and expiration dates.

    Product
    Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0182-2018·2018-01-17

    KRS Global Biotechnology Recalls Iodochlorhydroxyquin Otic Powder Due to Labeling Error

    KRS Global Biotechnology is recalling 40 jars of Iodochlorhydroxyquin Otic Powder because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0194-2018·2018-01-17

    KRS Global Biotechnology Recalls Sermorelin Cartridges Due to Labeling Errors

    KRS Global Biotechnology is recalling 80 Sermorelin cartridges because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0155-2018·2018-01-17

    Solco Healthcare Recalls Gabapentin Tablets Due to Labeling Error

    Solco Healthcare is recalling Gabapentin 800 mg tablets because some bottles contain 600 mg tablets. The error affects product distributed in Mason, Ohio.

    Product
    Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0154-2018·2018-01-17

    Allergan Recalls One Lot of Viokace Tablets Due to Stability Testing Failures

    Allergan is recalling one lot of Viokace tablets because stability testing results did not meet specifications for enzyme profile.

    Product
    Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0603-2018·2018-01-17

    Coconuthead Recalls CO YO Chocolate Coconut Yogurt Alternative Due to Container Bloating

    Coconuthead LLC is recalling CO YO Coconut Yogurt Alternative CHOCOLATE because the containers are bloating. The product was distributed nationwide.

    Product
    CO YO Coconut Yogurt Alternative CHOCOLATE, 5.3 oz and 12 oz. plastic container, 6 packages per case. Store between 36 and 42 F. Manufactured by COCONUTHEAD, LLC, Albuquerque NM; Distributed by UNFI and KeHE
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0163-2018·2018-01-17

    KRS Global Biotechnology Recalls Anastrozole SR Capsules Due to Labeling Errors

    KRS Global Biotechnology is recalling Anastrozole SR 1 mg capsules because the Beyond Use Dates exceed the expiration dates of some ingredients.

    Product
    Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0174-2018·2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Vials for Labeling Errors

    KRS Global Biotechnology is recalling 1,203 vials of Human Chorionic Gonadotropin due to incorrect or missing lot and expiration dates.

    Product
    Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0297-2018·2018-01-10

    Zimmer Biomet Recalls Lateral Troch Plate Due to Labeling Error

    Zimmer Biomet is recalling Lateral Troch Plate Full Crimp devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.

    Product
    Lateral Troch Plate Full Crimp - 254mm, model # 350838
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2018·2018-01-10

    Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Loosening

    Smiths Medical is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.

    Product
    Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0524-2018·2018-01-10

    Rapunzel Vegetable Bouillon Recalled for Misleading No Added Salt Label

    World Finer Foods is recalling Rapunzel Vegetable Bouillon because the front label claims no added salt, but sea salt is listed in the ingredients.

    Product
    Rapunzel Vegetable Bouillon ( no added salt ), 2.4 oz. net weight, in a thick paper sleeve containing 8 foil-wrapped bouillon cubes, 12 units per case .
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0302-2018·2018-01-10

    Zimmer Biomet Recalls CER BIOLOXD OPTION HD 32MM Due to Labeling Error

    Zimmer Biomet is recalling CER BIOLOXD OPTION HD 32MM implants because the internal patient label may be incorrect, although the outer box and product are correctly identified.

    Product
    CER BIOLOXD OPTION HD 32MM, model # 650-1056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0303-2018·2018-01-10

    Zimmer Biomet Recalls OSS Cemented IM Stem Due to Labeling Error

    Zimmer Biomet is recalling specific OSS Cemented IM Stem units because the internal patient label may be incorrect, although the outer box and product itself are correctly identified.

    Product
    OSS CEMENTED IM STEM 12X150, model # 150366
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2018·2018-01-10

    Zimmer Biomet Recalls COMP Primary Stem Due to Labeling Error

    Zimmer Biomet is recalling COMP Primary Stem 8MM MINI devices because the internal patient label may be incorrect, although the product itself is correctly identified.

    Product
    COMP PRIMARY STEM 8MM MINI, model # 113628
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0304-2018·2018-01-10

    Zimmer Biomet Recalls Femoral Distal Assembly Due to Internal Labeling Error

    Zimmer Biomet is recalling specific femoral distal assemblies because the internal patient label may be incorrect, although the outer box and product are correctly identified.

    Product
    RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0298-2018·2018-01-10

    Zimmer Biomet Recalls Hip Fracture Stem Due to Internal Label Error

    Zimmer Biomet is recalling specific hip fracture stems because the internal patient label may be incorrect, although the outer box and product are correctly identified.

    Product
    COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0300-2018·2018-01-10

    Zimmer Biomet Recalls ECHO POR FMRL NC 9X125 Due to Labeling Error

    Zimmer Biomet is recalling ECHO POR FMRL NC 9X125 medical devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.

    Product
    ECHO POR FMRL NC 9X125, model # 192009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0301-2018·2018-01-10

    Zimmer Biomet Recalls CER OPTION TYPE 1 TPR SLEVE -6 Due to Labeling Error

    Zimmer Biomet is recalling CER OPTION TYPE 1 TPR SLEVE -6 devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.

    Product
    CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0305-2018·2018-01-10

    Zimmer Biomet Recalls Distal Femoral Knee Implant Due to Labeling Error

    Zimmer Biomet is recalling a specific lot of distal femoral knee implant assemblies because the internal patient label may be incorrect, although the product itself is correctly identified.

    Product
    RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0307-2018·2018-01-10

    Smiths Medical CADD-Legacy 1 Pumps Recalled for Serial Number Mismatch

    Smiths Medical ASD Inc. is recalling 58 CADD-Legacy 1 Ambulatory Infusion Pumps because the physical label may not match the serial number programmed into the device software.

    Product
    CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0296-2018·2018-01-10

    Zimmer Biomet Recalls Lateral Troch Plate Due to Labeling Error

    Zimmer Biomet is recalling Lateral Troch Plate Full Crimp units because the internal patient label may be incorrect, though the product itself is correct.

    Product
    Lateral Troch Plate Full Crimp - 254mm, model # 350837
    Category
    Medical Device
    Distribution
    Distributed nationwide