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.

18451–18475 of 21645

  • ModerateFDA (Food)·F-1913-2014·2014-05-07

    Fish Oil Softgels Recalled Due to Mixed Conjugated Linoleic Acid Capsules

    Nutri-Force Nutrition is recalling Fish Oil Softgel Capsules because Conjugated Linoleic Acid capsules were found mixed in the bottles.

    Product
    Fish Oil Softgel Capsules in white High Density Poly-Ethylene bottles labeled in part: "Major [brand] Fish Oil Cholesterol Free 1000 MG *** 100 Softgels *** Distributed by Major Pharmaceuticals ***Livonia, MI 48150 USA ***".
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1518-2014·2014-05-07

    Siemens Recalls IMMULITE 2000 Total IgE Assays Due to Positive Bias

    Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE 2000 Total IgE assays because they show a 23% positive bias against the WHO standard.

    Product
    IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1262-2014·2014-05-07

    Piramal Recalls Sevoflurane Inhalation Anesthetic Due to pH Failure

    Piramal Critical Care is recalling 12,600 bottles of Sevoflurane inhalation anesthetic because the product was too acidic, failing pH specifications.

    Product
    SEVOFLURANE — SEVOFLURANE (SEVOFLURANE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1527-2014·2014-05-07

    Laurimed Recalls PolypVac Microdebriders Due to Premature Mechanism Shutdown

    Laurimed LLC is recalling 58 PolypVac 3.5mm Microdebriders because the reciprocation mechanism may turn off prematurely due to a component failure in the handle.

    Product
    PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1525-2014·2014-05-07

    Medtronic Activa Neurostimulators Recalled for Cycling Feature Labeling

    Medtronic is recalling Activa neurostimulators because current labeling indicates the cycling feature improves device longevity and recharge interval.

    Product
    Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1291-2014·2014-05-07

    AbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection Device

    AbbVie is recalling 2,915 Lupron Depot kits because the syringe needle protection device may be defective. The recall covers nationwide distribution and Puerto Rico.

    Product
    LUPRON DEPOT — LUPRON DEPOT (LEUPROLIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1257-2014·2014-05-07

    John W Hollis Inc Recalls Phosphatidylcholine Injection Due to Labeling Error

    John W Hollis Inc is recalling 7 vials of Phosphatidylcholine Solution for Injection because the expiration date on the label is earlier than the date listed on the vial.

    Product
    Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1522-2014·2014-05-07

    Integra CUSA Excel Disposable Wrench Recalled for Incorrect Assembly

    Integra LifeSciences is recalling CUSA Excel Disposable Wrenches because some units were incorrectly assembled with the wrong hex wrench insert.

    Product
    Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1483-2014·2014-05-07

    Hospira Acclaim Encore Infusion Pump Recall for Broken Door Assemblies

    Hospira is recalling 13,218 Acclaim Encore infusion pumps because broken door assemblies may prevent proper closure, causing unrestricted flow or therapy delays.

    Product
    Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1287-2014·2014-05-07

    AbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection

    AbbVie is recalling 7,362 Lupron Depot kits because some may contain a syringe with a defective needle stick protection device.

    Product
    LUPRON DEPOT — LUPRON DEPOT (LEUPROLIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1284-2014·2014-05-07

    Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failure

    Caraco Pharmaceutical Laboratories is recalling 91,777 bottles of Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, because stability results showed the product did not meet drug release dissolution specifications.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1524-2014·2014-05-07

    Medtronic Neurostimulators Recalled for Cycling Feature Labeling Concerns

    Medtronic is recalling specific neurostimulators because current labeling indicates the cycling feature improves device longevity, a claim that may be inaccurate.

    Product
    Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1280-2014·2014-05-07

    Teva Recalls Fluoxetine Capsules Due to Chemical Contamination and Odor

    Teva Pharmaceuticals is recalling Fluoxetine Capsules due to a customer complaint trend regarding capsule odor, indicating chemical contamination.

    Product
    FLUOXETINE — FLUOXETINE (FLUOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1914-2014·2014-05-07

    Rising Moon Organics Pesto Ravioli Recalled for Missing Pine Nut Allergen Labeling

    Carmel Food Group is recalling Rising Moon Organics Basil, Asiago & Pine Nut Pesto Ravioli because the packaging incorrectly omits pine nuts from the allergen statement.

    Product
    RISING MOON ORGANICS BASIL ASIAGO PINE NUT PESTO RAVIOLI; 8 OZ PACKAGE (227g) Keep Frozen USDA Organic: Distributed by Rising Moon Organics 313 Iron Horse Way Providence, RI 02908
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1514-2014·2014-05-07

    Elekta Recalls HexaPOD evo RT Couchtop Units Due to Loose Screw Risk

    Elekta is recalling 266 HexaPOD evo RT Couchtop units because screws may become loose if not properly tightened with a torque wrench.

    Product
    HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Drugs)·D-1298-2014·2014-05-07

    P&L Developments Recalls Children's Cold and Cough Liquid for Precipitate

    P&L Developments is recalling 1,363,338 bottles of Children's Triacting Night Time Cold & Cough with PE because small amounts of diphenhydramine and mannitol precipitated out of solution.

    Product
    Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1290-2014·2014-05-07

    AbbVie Recalls Lupron Depot Kits With Defective Needle Protection

    AbbVie is recalling 1,530 Lupron Depot kits because some may contain a syringe with a defective needle stick protection device.

    Product
    LUPRON DEPOT — LUPRON DEPOT (LEUPROLIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1472-2014·2014-04-30

    Pega Medical Recalls Fassier-Duval IM Telescopic System Due to Labeling Error

    Pega Medical Inc. is recalling 48 units of the Fassier-Duval IM Telescopic System because the outer package label listed the incorrect device length.

    Product
    Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1500-2014·2014-04-30

    Meta Labs Recalls Nice-En-Smooth Berry Burst Lubricant for Unregistered Manufacturing

    Altasource LLC dba Meta Labs LLC is recalling Nice-En-Smooth Berry Burst lubricant because the firm is not registered as a drug manufacturer.

    Product
    Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1507-2014·2014-04-30

    Arrow Recalls Antimicrobial Central Venous Catheters Due to Labeling Error

    Arrow International is recalling 170 units of Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheters because the lidstock incorrectly lists the catheter length as 16CM instead of 20CM.

    Product
    Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Drugs)·D-1242-2014·2014-04-30

    Nicorette Lozenges Recalled for Thickness and Potency Failures

    GlaxoSmithKline is recalling Nicorette 2 mg lozenges because they failed specifications for thickness, softness, and potency.

    Product
    Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1253-2014·2014-04-30

    Pfizer Recalls Tikosyn Capsules Due to Foreign Object Contamination

    Pfizer is recalling Tikosyn (dofetilide) 500 mcg capsules because a single 250 mcg capsule was found in one bottle. The recall covers 23,064 bottles distributed nationwide.

    Product
    Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1254-2014·2014-04-30

    P&L Developments Recalls Subpotent Day Time Cold & Flu OTC Drug

    P&L Developments, LLC is recalling 2,500,510 bottles of Day Time Cold & Flu because the phenylephrine component is subpotent.

    Product
    Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron…
    Category
    Drug
    Distribution
    Distributed nationwide