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.

19176–19200 of 21751

  • ModerateFDA (Drugs)·D-860-2014·2014-01-29

    FDA Recalls Fenofibrate Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Fenofibrate 54 mg tablets that may have been mislabeled as Famciclovir 500 mg.

    Product
    FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115551110.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-792-2014·2014-01-29

    Cilostazol Tablets Recalled for Potential Label Mixup with Calcium Acetate

    Aidapak Services is recalling Cilostazol 100 mg tablets due to a potential label mixup with Calcium Acetate capsules. The repacked drugs were distributed in four western states.

    Product
    CILOSTAZOL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054004421.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-814-2014·2014-01-29

    Fluvastatin Sodium Capsules Recalled for Potential Labeling Error

    Aidapak Services is recalling Fluvastatin Sodium 20 mg capsules because they may be mislabeled as Valsartan 80 mg tablets.

    Product
    FLUVASTATIN SODIUM, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078017615.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0811-2014·2014-01-29

    Ziemer FEMTO LDV Z2, Z4, and Z6 Lasers Recalled for Monitor Overheating

    Ziemer USA Inc. is recalling five FEMTO LDV femtosecond surgical lasers because a controller board defect may cause the video monitor to overheat and shut off.

    Product
    1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-802-2014·2014-01-29

    Aidapak Recalls Phenol Lozenges Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Phenol Lozenges because they may have been mislabeled as Atorvastatin Calcium or Vitamin B Complex W/C tablets.

    Product
    PHENOL, LOZENGE, 29 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00068021918.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-788-2014·2014-01-29

    Aidapak Recalls Flecainide Acetate Tablets Due to Label Mixup

    Aidapak Services, LLC is recalling Flecaainide Acetate tablets because they may be mislabeled as Colestipol HCL Micronized.

    Product
    FLECAINIDE ACETATE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054001125.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-866-2014·2014-01-29

    Aidapak Recalls Methocarbamol Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Methocarbamol 500 mg tablets because they may have been mislabeled as Losartan Potassium 25 mg.

    Product
    METHOCARBAMOL, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00143129001.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-909-2014·2014-01-29

    Aidapak Recalls Fenofibrate Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling specific lots of Fenofibrate 54 mg tablets because they may have been mislabeled as other prescription drugs.

    Product
    FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378710077.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-812-2014·2014-01-29

    Levothyroxine Sodium Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Levothyroxine Sodium tablets that may have been mislabeled as Multivitamin/Multimineral tablets.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074929690.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1017-2014·2014-01-29

    Aidapak Recalls Pyridoxine HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 403 tablets of Pyridoxine HCL 50 mg because they may have been mislabeled as other medications. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

    Product
    PYRIDOXINE HCL, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052060.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-783-2014·2014-01-29

    Aidapak Recalls Pancrelipase DR Capsules Due to Potential Label Mixup

    Aidapak Services is recalling Pancrelipase DR capsules because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032121201.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-805-2014·2014-01-29

    Pregabalin Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Pregabalin 25 mg capsules because they may have been mislabeled as Cholecalciferol or Glyburide.

    Product
    PREGABALIN, Capsule, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071101268.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-849-2014·2014-01-29

    Aidapak Recalls Irbesartan Tablets Due to Potential Labeling Error

    Aidapak Services is recalling 150 mg Irbesartan tablets because they may have been mislabeled as Benazepril HCl 40 mg.

    Product
    IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093746556.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1029-2014·2014-01-29

    Selenium Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling 50 mcg selenium tablets that may be mislabeled as guaifenesin ER 600 mg.

    Product
    SELENIUM, Tablet, 50 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904316260.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-648-2014·2014-01-22

    Sulfasalazine Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Sulfasalazine 500 mg tablets because they may be mislabeled as Hyoscyamine Sulfate 0.125 mg.

    Product
    sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0768-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues

    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
    MCA7-2SB - 2MM 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-488-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 2,998 tablets of Cholecalciferol 2000 units because they may be mislabeled as other medications.

    Product
    CHOLECALCIFEROL, Tablet, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904615760
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-406-2014·2014-01-22

    Betachem Recalls Metformin Hydrochloride API Due to CGMP Deviations

    Betachem, Inc. is recalling 27,000 kilos of Metformin Hydrochloride USP active pharmaceutical ingredient because it was not manufactured according to current good manufacturing practices.

    Product
    Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No.…
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0734-2014·2014-01-22

    Remel Recalls Oxoid Antimicrobial Susceptibility Testing Discs Due to Impregnation Defect

    Remel Inc is recalling Oxoid Antimicrobial Susceptibility Testing Discs because individual discs may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.

    Product
    Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0715-2014·2014-01-22

    Anspach MCA Cutting Burr Recalled for Inadequate Labeling Instructions

    The Anspach Effort, Inc. is recalling MCA Cutting Burs because the current directions for use do not provide sufficient details regarding the intended use for these specific burs.

    Product
    Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-523-2014·2014-01-22

    Sertraline HCL Tablets Recalled for Potential Labeling Errors

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

    Product
    SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-554-2014·2014-01-22

    FDA Recalls Fexofenadine Tablets Due to Potential Labeling Error

    Aidapak Services is recalling Fexofenadine HCL 180 mg tablets because they may be mislabeled as Multivitamin/Multimineral tablets.

    Product
    FEXOFENADINE HCL, Tablet 180 mg, Rx only, Distributed by: AidaPak Service, LLC,NDC 41167412003
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-679-2014·2014-01-22

    Aidapak Recalls Mislabeled Atenolol Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Atenolol tablets that may be mislabeled as Vitamin B Complex or Piroxicam. The error involves specific pedigree codes and expiration dates.

    Product
    ATENOLOL Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 63304062101
    Category
    Drug
    Distribution
    4 states