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.

3176–3200 of 3531

  • ModerateFDA (Drugs)·D-0073-2022·2021-11-03

    AERO Tab Pain Reliever Tablets Recalled for Failed Stability Specifications

    Ultra Seal Corporation is recalling AERO Tab Pain Reliever tablets nationwide because out-of-specification results were found for Salicylic Acid, an Aspirin-related compound, indicating failed stability testing.

    Product
    AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0078-2022·2021-11-03

    Rizatriptan Benzoate Tablets Recall Due to Out-of-Specification Impurities

    MacLeods Pharma USA is recalling Rizatriptan Benzoate Film Coated Tablets (10 mg) due to out-of-specification test results in organic impurities testing. The recall affects multiple lot numbers distributed nationwide.

    Product
    RIZATRIPTAN — RIZATRIPTAN (RIZATRIPTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0163-2022·2021-11-03

    Pneupac paraPac plus 300 ventilator kit recalled for duplicate serial number

    Smiths Medical recalled two Pneupac paraPac plus 300 ventilator kits distributed in the UK that were labeled with the same serial number, preventing differentiation between the two units.

    Product
    Pneupac paraPac plus 300 ventilator kit, REF P300NGB
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0151-2022·2021-10-27

    HemosIL Liquid Anti-Xa Assay On-Board Stability Issue Recall

    Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa, a coagulation assay measuring heparin activity, due to reduced on-board instrument stability from 7 days to 5 days.

    Product
    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0018-2022·2021-10-27

    Cleaning Solutions Foaming Hand Sanitizer Recalled for Skin Irritation Risk

    Sanitor Corporation is recalling Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%) due to contamination from Current Good Manufacturing Practice (CGMP) deviations. Use may cause skin or soft tissue infection and irritation.

    Product
    Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0021-2022·2021-10-27

    AirDuo Digihaler 113/14 Inhalation Powder Subpotent Drug Recall

    Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some units contain less salmeterol than the labeled dose. The affected sample batch was distributed nationwide.

    Product
    AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0017-2022·2021-10-27

    Coppertone Pure & Simple Baby 50 Sunscreen Spray Recalled for cGMP Deviations

    Beiersdorf Inc. is recalling 14,748 cans of Coppertone Pure & Simple baby 50 Sunscreen Spray due to cGMP (current Good Manufacturing Practice) deviations. The product was distributed nationwide.

    Product
    Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0019-2022·2021-10-27

    Rocuronium Bromide Injection Lacks Paralyzing Agent Warning

    Piramal Critical Care is recalling Rocuronium Bromide Injection because the finished product vial lacks the required "WARNING: PARALYZING AGENT" statement on the flip cap. The missing warning could lead to unsafe use of this prescription neuromuscular-blocking drug.

    Product
    Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0016-2022·2021-10-27

    Coppertone Pure & Simple Kids 50 Sunscreen Spray Recalled for cGMP Deviations

    Beiersdorf Inc. is voluntarily recalling Coppertone Pure & Simple kids 50 Sunscreen Spray due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 70,320 cans distributed nationwide.

    Product
    Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0120-2022·2021-10-27

    Diagnostic Control Material Outside Expected Range, Potential for Delayed Results

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Immunodiagnostic Controls that may be outside the expected control range, potentially delaying diagnostic test results in laboratory systems.

    Product
    VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0024-2022·2021-10-27

    AirDuo Digihaler inhalation powder subpotent drug recall

    Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some batches do not deliver the labeled amount of salmeterol, a critical active ingredient for asthma and COPD control.

    Product
    AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·22008·2021-10-27

    5.11 Tactec Plate Carriers Recalled Due to Injury Hazard

    5.11 Inc. is recalling about 45,170 Tactec Plate Carriers (style 56100) because the cable in the quick release system can separate from the handle, preventing swift removal in an emergency. No injuries have been reported.

    Product
    56100 Tactec™ Plate Carriers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0026-2022·2021-10-27

    Omeprazole Magnesium Acid Reducer Capsules Recalled for Staple Contamination

    Dr. Reddy's Laboratories is recalling Acid Reducer (Omeprazole Magnesium) 20 mg capsules nationwide because staples have been found co-mingled with capsules in bottles.

    Product
    ACID REDUCER — ACID REDUCER (OMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0143-2022·2021-10-27

    Smith & Nephew cannulated screw label incorrectly indicates threading type

    Smith & Nephew is recalling 6.5mm x 165mm cannulated screws because the product label incorrectly states the screws are fully threaded when they are actually partially threaded.

    Product
    6.5MMX165MM CANNULATED SCREW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0126-2022·2021-10-27

    Plastic Tenaculum Surgical Instruments Recalled for Unconfirmed Manufacturing Standards

    Stradis Medical is recalling plastic tenaculum surgical instruments because the manufacturer cannot confirm they were produced in accordance with required design and manufacturing standards. Approximately 2,483 kits were distributed nationwide and to Canada.

    Product
    Tenaculum, Plastic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0020-2022·2021-10-27

    GlipiZIDE Extended-Release Tablets 2.5 mg Nationwide Recall

    American Health Packaging is recalling GlipiZIDE Extended-Release Tablets 2.5 mg (Lot #194141) nationwide because dissolution test results exceeded specification, which may affect the drug's effectiveness.

    Product
    GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0149-2022·2021-10-27

    Heparin Activity Assay Labeling Correction: Reduced On-Board Stability

    Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa kits due to a labeling correction. The on-board stability window has been reduced from 7 to 5 days.

    Product
    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2022·2021-10-27

    AirDuo Digihaler 232/14 Inhalation Powder Recall for Subpotent Salmeterol

    Teva Pharmaceuticals is recalling approximately 5,500 units of AirDuo Digihaler 232/14 inhalation powder distributed nationwide because some inhalers contain less salmeterol than the labeled dose.

    Product
    AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0154-2022·2021-10-27

    Jamshidi Bone Marrow Biopsy Tray Recalled Due to Misbranding

    Bard Peripheral Vascular Inc. is recalling 360 Jamshidi Bone Marrow Biopsy Trays (Catalog # BEK3411, Lot # 0001378561) due to misbranded labeling. The FDA classified this as a Class II recall affecting healthcare facilities in 16 U.S. states and Puerto Rico.

    Product
    Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Inf
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Drugs)·D-0022-2022·2021-10-27

    AirDuo Digihaler 232/14 Inhalation Powder Subpotent Recall

    Teva Pharmaceuticals is recalling AirDuo Digihaler 232/14 inhalation powder because some units do not deliver the correct amount of salmeterol as labeled.

    Product
    AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0015-2022·2021-10-27

    Coppertone Pure & Simple 50 Sunscreen Spray Recall for cGMP Deviations

    Beiersdorf Inc. is recalling Coppertone Pure & Simple 50 Sunscreen Spray due to manufacturing practice deviations. Approximately 36,660 cans were distributed nationwide.

    Product
    Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0027-2022·2021-10-27

    Lupin Imipramine Pamoate Capsules Recalled for Failed Dissolution Test

    Lupin Pharmaceuticals is recalling approximately 1,902 bottles of Imipramine Pamoate Capsules 125 mg due to out-of-specification results in dissolution testing at the 9-month stability checkpoint.

    Product
    IMIPRAMINE PAMOATE — IMIPRAMINE PAMOATE (IMIPRAMINE PAMOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0114-2022·2021-10-20

    Flower Lag Screw Kit drill bits missing AO connect feature recalled

    Flower Orthopedics is recalling Flower Lag Screw Kit 2.7 mm because drill bits lack the AO connect feature, which may delay surgical procedures.

    Product
    Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the med
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0080-2022·2021-10-20

    Philips HeartStart HS1 Home Defibrillator: Customers Not Notified of Previous Recalls

    Philips is recalling nine units of the HeartStart HS1 Home Defibrillator (Model M5068A) because customers were not notified of previous recalls associated with various defibrillator models.

    Product
    Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-0012-2022·2021-10-20

    Fairlife Milk 8oz 6-Pack Chocolate Recalled for Spoilage Risk

    Fairlife Llc is recalling Fairlife Milk 8oz 6-pack chocolate bottles with date code MAY2722 FA due to potential spoilage and lack of commercial sterility. The affected product was distributed to retailers in Arizona, California, Oregon, Utah, Washington, and military distributors.

    Product
    FAIRLIFE MILK 8OZ / 6PK CHOCOLATE (multi-pack format of small single serve bottle); Date Code "MAY2722 FA"; Case UPC 008-11620-02207-1; Unit UPC 008-11620-02206-4
    Category
    Food
    Distribution
    5 states