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.

16201–16225 of 21645

  • ModerateFDA (Devices)·Z-2009-2015·2015-07-15

    Stradis Face Lift Pack Recalled Due to Component Recall

    Stradis Healthcare is recalling Face Lift Packs because they contain a Devon Light Glove that is being recalled by its manufacturer, Medtronic.

    Product
    Face Lift Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1220-2015·2015-07-15

    Amlodipine besylate tablets recalled for inadequate complaint investigation

    American Health Packaging is recalling Amlodipine besylate tablets 10 mg due to current Good Manufacturing Practice (CGMP) deviations involving inadequate investigation of customer complaints.

    Product
    Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); 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 (Drugs)·D-1233-2015·2015-07-15

    BioComp Pharma Recalls Subpotent Thera-Gesic Pain Relieving Creme Sachets

    BioComp Pharma is recalling 40,000 sachets of Thera-Gesic Pain Relieving Creme because the active ingredients menthol and methyl salicylate are below specification.

    Product
    Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet, OTC, Manufactured for Mission Pharmacal Company 10999 IH 10 West, Suite 1000 San Antonio, TX 78230 by Mission Pharmacal Company 38505 IH 10…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1214-2015·2015-07-15

    Apotex Recalls Losartan Potassium Tablets for Uniformity Issues

    Apotex Inc. is recalling 23,076 bottles of Losartan potassium tablets 50 mg because the product may not meet blend uniformity specifications.

    Product
    Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2006-2015·2015-07-15

    Stradis Tummy Tuck Pack Recalled Due to Component Defect

    Stradis Healthcare is recalling Tummy Tuck Packs because they contain a Devon Light Glove component that is subject to a separate recall by Medtronic.

    Product
    Tummy Tuck Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2051-2015·2015-07-15

    Synthes Recalls Three Titanium Tibial Nail End Caps for Missing Inspection

    Synthes is recalling three units of a titanium end cap for tibial nails because they were shipped before a required internal inspection was completed.

    Product
    TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2001-2015·2015-07-15

    Stradis Vaginal Rejuvenation Pack Recalled Due to Component Recall

    Stradis Healthcare is recalling Vaginal Rejuvenation Packs because they contain a Devon Light Glove component that Medtronic is recalling.

    Product
    Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2037-2015·2015-07-15

    Stradis Blepharoplasty Packs Recalled Due to Component Recall

    Stradis Healthcare is recalling Blepharoplasty Packs because they contain Devon Light Gloves, which are subject to a separate recall by Medtronic.

    Product
    Blepharoplasty Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2042-2015·2015-07-15

    Stradis Upper Extremity Packs Recalled Due to Component Defect

    Stradis Healthcare is recalling Upper Extremity Packs because they contain a Devon Light Glove component being recalled by Medtronic.

    Product
    Upper Extremity Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1988-2015·2015-07-15

    Allergan Recalls Expired Natrelle Breast Implant Sizers

    Allergan is recalling 9 units of expired Natrelle 410cc Re-Sterilizable Breast Implant Sizers because they were shipped to the user level.

    Product
    Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-1218-2015·2015-07-15

    Amlodipine besylate tablets recalled for inadequate complaint investigation

    American Health Packaging is recalling 1,896 cartons of Amlodipine besylate tablets 2.5mg due to inadequate investigation of customer complaints.

    Product
    Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); 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-1994-2015·2015-07-15

    Stradis Advanced Vein Care Kits Recalled Due to Component Recall

    Stradis Healthcare is recalling Advanced Vein Care kits because they contain a Devon Light Glove component recalled by Medtronic.

    Product
    Advanced Vein Care - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2004-2015·2015-07-15

    Stradis Healthcare Recalls Laser Evlt Packs Due to Component Recall

    Stradis Healthcare is recalling three Laser Evlt Packs and Laser One Leg Evlt kits because they contain a Devon Light Glove component recalled by Medtronic.

    Product
    Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2016-2015·2015-07-15

    Stradis Vasc Custom Kits Recalled Due to Component Recall

    Stradis Healthcare is recalling Vasc Custom Kits because they contain Devon Light Gloves, which are being recalled by the manufacturer Medtronic.

    Product
    Vasc Custom Kit - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1229-2015·2015-07-15

    American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations

    American Health Packaging is recalling Lisinopril tablets 40mg due to inadequate investigation of customer complaints. The recall covers 1,516 cartons distributed nationwide.

    Product
    Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1227-2015·2015-07-15

    American Health Packaging Recalls Lisinopril Tablets Due to Complaint Investigation Failures

    American Health Packaging is recalling 13,532 cartons of Lisinopril 10mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2002-2015·2015-07-15

    Stradis Healthcare Recalls General Packs Containing Recalled Devon Light Gloves

    Stradis Healthcare is recalling General Packs that contain Devon Light Gloves. The recall is necessary because the glove manufacturer, Medtronic, is recalling the specific glove component.

    Product
    General Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2030-2015·2015-07-15

    Stradis Minor Pack Surgical Kits Recalled Due to Component Issue

    Stradis Healthcare is recalling Minor Pack and Minor Pack II surgical kits because they contain a recalled Devon Light Glove component.

    Product
    Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1224-2015·2015-07-15

    American Health Packaging Recalls Clarithromycin Tablets Due to CGMP Deviations

    American Health Packaging is recalling 3,572 cartons of Clarithromycin tablets, USP 500mg, because the firm did not adequately investigate customer complaints.

    Product
    Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2003-2015·2015-07-15

    Stradis Vein and Vascular Pack Recalled Due to Component Issue

    Stradis Healthcare is recalling Vein & Vascular Packs because they contain a Devon Light Glove component that is being recalled by its manufacturer, Medtronic.

    Product
    Vein & Vascular Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1213-2015·2015-07-15

    Apotex Recalls Losartan Potassium Tablets for Blend Uniformity Failure

    Apotex Inc. is recalling Losartan potassium tablets 100 mg because they may not meet blend uniformity specifications. The recall covers 23,178 bottles distributed nationwide, in Hawaii, and Puerto Rico.

    Product
    Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1232-2015·2015-07-15

    Hospira Recalls Magnesium Sulfate Injection Due to pH Specification Failure

    Hospira Inc. is recalling 106,900 vials of Magnesium Sulfate Injection, USP, 50% because 12-month stability testing failed pH specifications.

    Product
    Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2015·2015-07-15

    Stradis Head and Neck Surgical Packs Recalled Due to Component Issue

    Stradis Healthcare is recalling Head & Neck Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.

    Product
    Head & Neck Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide