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.

16101–16125 of 21645

  • ModerateFDA (Drugs)·D-1244-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling specific lots of Lisinopril 2.5 mg tablets because the manufacturer did not adequately investigate customer complaints.

    Product
    Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2184-2015·2015-07-29

    FDA Recalls American Medical Systems Fiber Strippers Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1267-2015·2015-07-29

    Wockhardt Recalls Famotidine Tablets Due to Complaint Investigation Failures

    Wockhardt USA LLC is recalling 1,002 drums of Famotidine Tablets, USP, 10 mg because the firm did not adequately investigate customer complaints.

    Product
    Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2205-2015·2015-07-29

    Philips Recalls Head Holders Shipped with Ingenuity CT Systems

    Philips Medical Systems is recalling 66 head holders shipped with Ingenuity CT systems because they were not qualified for use on this specific model.

    Product
    Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-2129-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counters Recalled for Barcode Label Error

    Perkinelmer is recalling 18 WIZARD2 gamma counters because a barcode label error may produce erroneous results.

    Product
    Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2204-2015·2015-07-29

    Philips Recalls Head Holders for Ingenuity Core 128 CT Systems

    Philips Medical Systems is recalling 55 head holders shipped with Ingenuity Core 128 CT systems because they were not qualified for use on this specific model.

    Product
    Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Drugs)·D-1263-2015·2015-07-29

    Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures

    Wockhardt USA LLC is recalling Azithromycin Tablets, USP, 500 mg because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2096-2015·2015-07-29

    Safety PICC Insertion Tray Recalled for Incorrect Non-Sterile Packaging Item

    Custom Healthcare Systems is recalling Safety PICC Insertion Trays because the outer packaging contains an incorrect non-sterile saline flush syringe.

    Product
    Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2103-2015·2015-07-29

    Allergan Recalls Natrelle Tissue Expanders Due to Expired Shelf Life

    Allergan is recalling Natrelle 133 and CUI Series Tissue Expanders because the shipped products were beyond their 47-month shelf life.

    Product
    Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1250-2015·2015-07-29

    Wockhardt Recalls Famotodine Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Famotodine Tablets, USP, 40 mg due to inadequate investigation of customer complaints.

    Product
    Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2208-2015·2015-07-29

    Silhouette Suture Brochure Recalled for Incomplete Risk Information

    Silhouette Lift, Inc. is recalling Silhouette Suture brochures because they omit a complete list of risks and side effects, potentially misleading patients about product safety.

    Product
    Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-1264-2015·2015-07-29

    Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling 7,584 bottles of Azithromycin 600 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2183-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2126-2015·2015-07-29

    Perkinelmer Recalls WIZARD2 Gamma Counters Due to Barcode Label Error

    Perkinelmer is recalling 53 WIZARD2 gamma counters because a barcode label error may produce erroneous results.

    Product
    WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1252-2015·2015-07-29

    Wockhardt Recalls Metoprolol Succinate Extended-Release Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1247-2015·2015-07-29

    Wockhardt Recalls Zolpidem Tartrate Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Zolpidem Tartrate 5 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1243-2015·2015-07-29

    Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Wockhardt USA LLC is recalling Amlodipine Besylate 2.5 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1268-2015·2015-07-29

    Wockhardt Recalls 15 mg Lansoprazole Capsules Due to CGMP Deviations

    Wockhardt USA is recalling 16,276 bottles of 15 mg Lansoprazole Delayed-Release Capsules because the firm did not adequately investigate customer complaints.

    Product
    Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2100-2015·2015-07-29

    Cook Inc. Recalls Ring Transjugular Intrahepatic Access Set Due to Dilator Length

    Cook Inc. is voluntarily recalling 661 Ring Transjugular Intrahepatic Access Sets and Flexor RTPS Introduce Sheaths because the dilators are too long.

    Product
    Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1272-2015·2015-07-29

    Wockhardt Recalls Metoprolol Succinate Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repacking Only (NDC: 64679-734-08) and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2171-2015·2015-07-29

    FDA Recalls Fiber Cleavers Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Cleavers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.

    Product
    1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2173-2015·2015-07-29

    American Medical Systems Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1274-2015·2015-07-29

    Wockhardt Recalls Zonisamide Capsules Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling Zonisamide Capsules, 25 mg, because the firm did not adequately investigate customer complaints.

    Product
    Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0945-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2864-2015·2015-07-29

    Great Harvest Bread Recalled for Potential Foreign Material Contamination

    Buckwheat Enterprises is recalling Great Harvest All You Need Bread due to potential contamination with foreign materials from recalled apricots.

    Product
    All You Need Bread, Each loaf is package in a bag with a net wt. 1 lb. 14 oz., sold under brand Great Harvest Bread Co.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1255-2015·2015-07-29

    Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Wockhardt USA is recalling Amlodipine Besylate 5 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054…
    Category
    Drug
    Distribution
    Distributed nationwide