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.

19401–19425 of 21751

  • ModerateFDA (Devices)·Z-0751-2014·2014-01-22

    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 the device's validation.

    Product
    MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. 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-477-2014·2014-01-22

    FDA Recalls Mislabeled Guaifenesin Tablets Distributed by Aidapak Services

    Aidapak Services is recalling 200 mg Guaifenesin tablets that may be mislabeled as Pancrelipase DR capsules. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

    Product
    GUAIFENESIN, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904515460
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0730-2014·2014-01-22

    Zimmer Recalls Palacos R+G Bone Cement Due to Labeling Error

    Zimmer, Inc. is recalling 1,534 units of Palacos R+G Radioplaque Bone Cement because the lot number on the patient label may not match the outer carton.

    Product
    Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-504-2014·2014-01-22

    FDA Recalls Omeprazole Capsules Due to Potential Labeling Mixup

    Aidapak Services is recalling Omeprazole/Sodium Bicarbonate capsules because they may be mislabeled as Lactobacillus GG or Pyridoxine HCL.

    Product
    OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-650-2014·2014-01-22

    FDA Recalls Quinapril HCL Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Quinapril HCL 10 mg tablets that may be mislabeled as Propranolol HCL 80 mg.

    Product
    QUINAPRIL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762502001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-559-2014·2014-01-22

    Aidapak Recalls Hyoscyamine Sulfate Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Hyoscyamine Sulfate ER tablets because they may be mislabeled as Sertraline HCL. The error involves a label mixup.

    Product
    HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43199001401
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-725-2014·2014-01-22

    Ramipril Capsules Recalled for Potential Label Mixup with Other Medications

    Aidapak Services is recalling Ramipril 2.5 mg capsules because they may be mislabeled as Propafenone HCl or Calcium Polycarbophil.

    Product
    RAMIPRIL, Capsule, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68180058901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-685-2014·2014-01-22

    FDA Recalls Benzoicaine/Menthol Lozenges Due to Potential Labeling Mixup

    Aidapak Services is recalling Benzoicaine/Menthol lozenges that may be mislabeled as Lubiprostone or Losartan Potassium.

    Product
    BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824072016
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-532-2014·2014-01-22

    FDA Recalls Propranolol Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Propranolol HCL tablets because they may be mislabeled as Lactobacillus GG capsules.

    Product
    PROPRANOLOL HCL Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011401
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-530-2014·2014-01-22

    Aidapak Recalls Propranolol Tablets Due to Potential Labeling Error

    Aidapak Services is recalling Propranolol HCL tablets that may be mislabeled as Lithium Carbonate ER due to a label mixup.

    Product
    PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-578-2014·2014-01-22

    Aidapak Recalls Nitrofurantoin Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Nitrofurantoin Macrocrystals capsules because they may be mislabeled as Phytonadione tablets.

    Product
    NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47781030701
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-468-2014·2014-01-22

    Coenzyme Q-10 Capsules Recalled for Potential Labeling Error

    Aidapak Services is recalling Coenzyme Q-10 capsules that may be mislabeled as Pancrelipase DR due to a label mixup.

    Product
    COENZYME Q-10, Capsule, 30 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904501546
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-688-2014·2014-01-22

    Aidapak Recalls Multivitamin Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling specific lots of multivitamin tablets because they may be mislabeled as other prescription medications.

    Product
    MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64376081601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-670-2014·2014-01-22

    Aidapak Recalls Isosorbide Mononitrate Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Isosorbide Mononitrate 20 mg tablets because they may be mislabeled as other medications. The affected repacked drugs were distributed in four western states.

    Product
    ISOSORBIDE MONONITRATE, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175010701
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-660-2014·2014-01-22

    Cilostazol Tablets Recalled for Potential Labeling Mixup with Dutasteride

    Aidapak Services is recalling Cilostazol 100 mg tablets because they may be mislabeled as Dutasteride 0.5 mg capsules.

    Product
    CILOSTAZOL Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505252201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0776-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Handles and Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L Trial Handles and Heads because the components may not be compatible. The devices were distributed only to the U.S. Department of Veterans Affairs.

    Product
    Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-591-2014·2014-01-22

    Aidapak Recalls Mislabeled HydrALAZINE HCl Tablets

    Aidapak Services, LLC is recalling hydrALAZINE HCl 50 mg tablets that may be mislabeled as CapsuleTOPRIL 12.5 mg tablets.

    Product
    hydrALAZINE HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032801
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-506-2014·2014-01-22

    FDA Recalls Chlorophyllin Copper Complex Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Chlorophyllin Copper Complex tablets that may be mislabeled as trazodone hydrochloride.

    Product
    CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 11868000901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-507-2014·2014-01-22

    Aidapak Recalls Paroxetine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Paroxetine HCl 10 mg tablets because they may be mislabeled as Pantoprazole Sodium DR 20 mg.

    Product
    PARoxetine HCl, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13107015430
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-587-2014·2014-01-22

    Doxepin HCL Capsules Recalled for Potential Label Mixup

    Aidapak Services is recalling Doxepin HCL capsules due to a labeling error where they may be mislabeled as Valsartan tablets.

    Product
    DOXEPIN HCL Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884022201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-493-2014·2014-01-22

    FDA Recalls Bisacodyl Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling 100-tablet bottles of Bisacodyl EC 5 mg tablets because they may be mislabeled as Cholecalciferol 400 units.

    Product
    BISACODYL EC, Tablet, 5 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904792760
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-681-2014·2014-01-22

    Lurasidone HCl Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Lurasidone HCl 120 mg tablets because they may be mislabeled as Duloxetine HCl DR 20 mg capsules.

    Product
    LURASIDONE HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402031230
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-684-2014·2014-01-22

    FDA Recalls GuaiFENesin ER Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling GuaiFENesin ER tablets because they may be mislabeled as Omega-3 acid ethyl esters capsules.

    Product
    guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000850
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-540-2014·2014-01-22

    Aidapak Recalls Caffeine Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling 200 mg caffeine tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    CAFFEINE Tablet, 200 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385060173
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-629-2014·2014-01-22

    Aidapak Recalls Metoprolol Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Metoprolol Tartrate 25 mg tablets because they may be mislabeled as Ascorbic Acid or Amlodipine Besylate.

    Product
    METOPROLOL TARTRATE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050652
    Category
    Drug
    Distribution
    4 states