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.

19426–19450 of 21751

  • ModerateFDA (Drugs)·D-631-2014·2014-01-22

    FDA Recalls Isosorbide Dinitrate Tablets Due to Labeling Error

    Aidapak Services is recalling Isosorbide Dinitrate ER tablets because they may be mislabeled as Cilostazol. Patients should check their medication labels.

    Product
    ISOSORBIDE DINITRATE ER Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664060088
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0764-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.

    Product
    MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-729-2014·2014-01-22

    Fluconazole Tablets Recalled Due to Potential Labeling Mixup

    Aidapak Services is recalling Fluconazole 100 mg tablets because they may be mislabeled as Prenatal Multivitamin/Multimineral tablets.

    Product
    FLUCONAZOLE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010230
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-699-2014·2014-01-22

    Aidapak Recalls Phosphorus Tablets Due to Potential Label Mixup

    Aidapak Services is recalling 250 mg Phosphorus tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    PHOSPHORUS Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980010401
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-516-2014·2014-01-22

    Venlafaxine Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Venlafaxine 25 mg tablets because they may be mislabeled as Omeprazole/Sodium Bicarbonate capsules.

    Product
    VENLAFAXINE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714031101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-700-2014·2014-01-22

    Lactobacillus Tablets Recalled for Potential Labeling Errors

    Aidapak Services, LLC is recalling Lactobacillus tablets due to a label mixup that may cause them to be mislabeled as other medications.

    Product
    LACTOBACILLUS Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980012950
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-621-2014·2014-01-22

    FDA Recalls Tizanidine Tablets Due to Potential Labeling Mixup

    Aidapak Services is recalling Tizanidine HCl tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    tiZANidine HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-601-2014·2014-01-22

    Etodolac Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Etodolac 400 mg tablets due to a potential label mixup with Pancrelipase DR capsules.

    Product
    ETODOLAC Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401801
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-585-2014·2014-01-22

    Aidapak Recalls Aspirin EC Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Aspirin EC DR tablets because they may be mislabeled as Melatonin or Docusate Sodium.

    Product
    ASPIRIN EC DR Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348098015
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-599-2014·2014-01-22

    Aidapak Recalls Pyridoxine HCL Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Pyridoxine HCL 50 mg tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    PYRIDOXINE HCL Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51645090901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-553-2014·2014-01-22

    Aidapak Recalls Omega-3 Fatty Acid Capsules Due to Labeling Error

    Aidapak Services, LLC is recalling Omega-3 Fatty Acid Capsules, 1000 mg, because they may be mislabeled as other medications. The affected products were distributed in Arizona, California, Oregon, and Washington.

    Product
    OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022921
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-535-2014·2014-01-22

    Aidapak Recalls Multivitamin Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling specific lots of multivitamin capsules that may be mislabeled as caffeine or melatonin tablets.

    Product
    MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24208063210
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0627-2014·2014-01-15

    RTI Surgical Recalls C-Plus Implants Due to Labeling Documentation Error

    RTI Surgical is recalling 1,906 C-Plus 10mm x 12mm Webless implants because they were incorrectly documented as meeting labeling requirements for a partial Vertebral Body Replacement Device.

    Product
    C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0630-2014·2014-01-15

    Stryker Color Cuff Tourniquet Cuffs Recalled for Incorrect Connector

    Stryker is recalling specific Color Cuff tourniquets because they may have the wrong connector, which can make the system inoperable.

    Product
    Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0622-2014·2014-01-15

    Integra Rickham Reservoirs Recalled for Bent or Broken Connectors

    Integra LifeSciences is recalling 78 packages of Rickham-Style Reservoirs due to bent or broken connectors found after opening sterile packages.

    Product
    Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining…
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0708-2014·2014-01-15

    Anspach Recalls Micro Curved Attachments Due to Unclear Directions for Use

    The Anspach Effort, Inc. is recalling MCA Micro Curved Attachments and cutting burrs because the directions for use do not clearly specify intended use for delicate bone in otologic procedures.

    Product
    Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0628-2014·2014-01-15

    Materialise Recalls Shipped Femur Guide Due to Fit Conformance Issue

    Materialise USA LLC is recalling a specific lot of shipped femur guides from the Signature Personalized Patient Care System because a non-conformance could impact the fit of the drill insert.

    Product
    REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-1383-2014·2014-01-15

    Safeway Kitchens In Shell Edamame Recalled for Pesticide Residue

    Safeway Inc is recalling 22 cases of In Shell Edamame after FDA testing detected trace amounts of the pesticide chlorafluazuron.

    Product
    Safeway Kitchens In Shell Edamame; Net Wt: 48 oz. (3 lb, 1.35Kg) 12 x 3 lb bags per case: Product of China: Packed in Canada Safeway, Pleasanton, CA.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1354-2014·2014-01-08

    Gold Label Shrimp Dip Recalled for Undeclared Red #40 Color Additive

    Hahn, Harry O Seafood Inc is recalling Gold Label Shrimp Dip because the raw shrimp ingredient contained Red #40 color additive, which was not declared on the finished product label.

    Product
    Gold Label Shrimp Dip in 7 oz plastic containers, Manufactured by Adelphia Seafood, ingredients: cream cheese (pasteurized milk & cream, cheese culture, salt, stabilizers (carob bean and/or xanthan gums), water, shrimp, surimi (fish protein (pollock, cod and/or pacific whiting)…
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0608-2014·2014-01-08

    Zimmer Recalls CPT Hip System Components Due to Incorrect Packaging

    Zimmer is recalling specific CPT Hip System parts because they were packaged in the wrong outer cartons, though the product labels are correct.

    Product
    CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0604-2014·2014-01-08

    Advanced Sterilization Products Recalls STERRAD Cyclesure Biological Indicators

    Advanced Sterilization Products is recalling STERRAD Cyclesure Biological Indicators due to a microscopic flaw in the outer vial.

    Product
    STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0605-2014·2014-01-08

    Steris Recalls Verify Dual Species Biological Indicators Due to Spore Count Defect

    Steris is recalling Verify Dual Species Self-Contained Biological Indicators because the spore count is lower than labeled, potentially causing false sterilization results.

    Product
    VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.
    Category
    Medical Device
    Distribution
    Distributed nationwide