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.

19251–19275 of 21751

  • ModerateFDA (Drugs)·D-732-2014·2014-01-22

    Rasagiline Mesylate Tablets Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling Rasagiline Mesylate tablets because they may be mislabeled as Omega-3 Fatty Acid capsules.

    Product
    RASAGILINE MESYLATE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68546014256
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-407-2014·2014-01-22

    B. Braun Recalls Sodium Chloride Injection Due to Incorrect Bar Code Labeling

    B. Braun Medical Inc. is recalling 19,572 bags of 0.45% Sodium Chloride Injection because the bar code incorrectly identifies the product as Potassium Chloride.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-555-2014·2014-01-22

    FDA Recalls Potentially Mislabeled Levothyroxine/Liothyronine Tablets

    Aidapak Services is recalling Levothyroxine/Liothyronine tablets that may be mislabeled as Magnesium Gluconate Dihydrate.

    Product
    LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42192032901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0765-2014·2014-01-22

    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 and directions for use were unclear.

    Product
    MCA7-15SD - 1.5MM Diamond 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-581-2014·2014-01-22

    Lactobacillus GG Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Lactobillus GG capsules because they may be mislabeled as aspirin, zonisamide, or venlafaxine.

    Product
    LACTOBACILLUS GG Capsule, 15 Billion Cells, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-556-2014·2014-01-22

    Liothyronine Sodium Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Liothyronine Sodium 5 mcg tablets because they may be mislabeled as Hydrochlorothiazide 12.5 mg.

    Product
    LIOTHYRONINE SODIUM, Tablet, 5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42794001802
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Food)·F-1396-2014·2014-01-22

    Jensen's Recalls Unlabeled Hot Smoked Salmon Products

    Jensen's Old Fashioned Smokehouse is recalling Great Ruby Fish Co. and Rolf's Choice hot smoked salmon products that lack 'KEEP FROZEN' labels.

    Product
    Great Ruby Fish Co products are such as Keta and King Hot smoked salmon. No labels provided. Products are labeled with lot code sticker and "KEEP FROZEN" sticker on individual units. The customer applies their own label upon receipt. Rolf's Choice Sockeye hot smoked…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-584-2014·2014-01-22

    Nicotine Polacrilex Lozenges Recalled for Potential Labeling Mixup

    Aidapak Services is recalling 2 mg Nicotine Polacrilex Lozenges because they may be mislabeled as Vitamin B Complex tablets.

    Product
    NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49348085216
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-469-2014·2014-01-22

    FDA Recalls Pseudoephedrine Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling pseudoephedrine HCL tablets because they may be mislabeled as d-alpha tocopheryl acetate capsules.

    Product
    PSEUDOEPHEDRINE HCL, Tablet, 30 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC, NDC 00904505360
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0766-2014·2014-01-22

    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
    MCA7-1SB - 1MM 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-693-2014·2014-01-22

    Zonisamide Capsules Recalled Due to Potential Labeling Mixup

    Aidapak Services is recalling Zonisamide capsules that may be mislabeled as Phytonadione tablets due to a labeling error.

    Product
    ZONISAMIDE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679099001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-549-2014·2014-01-22

    FDA Recalls Coenzyme Q-10 Capsules Due to Potential Labeling Errors

    Aidapak Services is recalling Coenzyme Q-10 capsules because they may be mislabeled as other prescription or over-the-counter medications.

    Product
    COENZYME Q-10, Capsule 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 37205055065
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-656-2014·2014-01-22

    Sennosides Tablets Recalled for Potential Labeling Mixup with Saccharomyces Boulardii

    Aidapak Services, LLC is recalling Sennosides Tablets due to a potential labeling mixup with Saccharomyces Boulardii capsules. The error involves incorrect product identification on the label.

    Product
    SENNOSIDES Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258095001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0767-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

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

    Product
    MCA7-1SD - 1MM Diamond 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-548-2014·2014-01-22

    Aidapak Recalls Multivitamin Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling multivitamin tablets that may be mislabeled as quetiapine or docusate sodium. The recall covers specific lots distributed in four western states.

    Product
    MULTIVITAMIN/MULTIMINERAL Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 37205018581
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-543-2014·2014-01-22

    Aidapak Recalls Cranberry Extract Capsules Due to Label Mixup

    Aidapak Services is recalling Cranberry Extract/Vitamin C capsules because they may be mislabeled as other medications. The products were distributed in four western states.

    Product
    CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 31604014271
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-489-2014·2014-01-22

    Aidapak Recalls Ferrous Sulfate Tablets Due to Potential Label Mixup

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

    Product
    FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904759160
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0769-2014·2014-01-22

    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
    MCA7-2SD - 2MM Diamond 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 (Devices)·Z-0712-2014·2014-01-22

    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter Recall

    Boston Scientific is recalling 34 units of Extractor Pro XL Retrieval Balloon Catheters due to potential incorrect skive hole location or balloon size.

    Product
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-513-2014·2014-01-22

    Prednisone Tablets Recalled for Potential Label Mixup with Aspirin

    Aidapak Services is recalling prednisone tablets that may be mislabeled as aspirin/dipyridamole capsules due to a labeling error.

    Product
    prednisoLONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC,NDC 16477050501
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-560-2014·2014-01-22

    Lactobacillus Acidophilus Capsules Recalled for Potential Label Mixup

    Aidapak Services is recalling Lactobacillus Acidophilus capsules because they may be mislabeled as Melatonin or Cranberry Extract products.

    Product
    LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 43292050022
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-637-2014·2014-01-22

    Aidapak Recalls Sevelamer Carbonate Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Sevelamer Carbonate tablets because they may be mislabeled as other prescription drugs.

    Product
    SEVELAMER CARBONATE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468013001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-687-2014·2014-01-22

    Aidapak Recalls Multivitamin Chew Tablets Due to Labeling Error

    Aidapak Services is recalling multivitamin chew tablets that may be mislabeled as a different prescription medication.

    Product
    MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64376081501
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-612-2014·2014-01-22

    Aidapak Recalls Trimethobenzamide Capsules Due to Potential Label Mixup

    Aidapak Services is recalling Trimethobenzamide HCl capsules because they may be mislabeled as other medications. The affected drugs were distributed in four western states.

    Product
    TRIMETHOBENZAMIDE HCl Capsule, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 53489037601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-572-2014·2014-01-22

    Aidapak Recalls Acetaminophen Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling specific acetaminophen tablets that may be mislabeled as multivitamin chew tablets. The error involves a label mixup.

    Product
    ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 46122010478
    Category
    Drug
    Distribution
    4 states