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.

12701–12725 of 21617

  • ModerateFDA (Drugs)·D-0831-2017·2017-05-31

    Advanced Pharma Recalls Succinylcholine Chloride for Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Succinylcholine Chloride because the product may contain latex but lacks proper labeling.

    Product
    Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0826-2017·2017-05-31

    Advanced Pharma Recalls Ephedrine Sulfate Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Ephedrine Sulfate because the product may contain latex but lacks proper labeling.

    Product
    Ephedrine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0812-2017·2017-05-31

    Advanced Pharma Recalls Morphine Sulfate for Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Morphine Sulfate because the product labeling does not indicate that it may contain synthetic or natural latex.

    Product
    Morphine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0835-2017·2017-05-31

    Advanced Pharma Recalls Rocuronium Bromide Due to Latex Labeling

    Advanced Pharma Inc. is recalling all strengths and forms of Rocuronium Bromide because the product may contain latex without proper labeling.

    Product
    Rocuronium Bromide all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0832-2017·2017-05-31

    Advanced Pharma Recalls Adenosine Due to Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Adenosine because the product may contain latex but lacks appropriate labeling.

    Product
    Adenosine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0860-2017·2017-05-31

    Mylan Recalls Tarina Fe 1/20 Tablets Due to Chemical Contamination

    Mylan Pharmaceuticals is recalling Tarina Fe 1/20 tablets due to chemical contamination from paint thinner vapors during manufacturing.

    Product
    Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2120-2017·2017-05-31

    Bard StatLock IV Premium Catheter Stabilization Device Recalled for Sizing Error

    Bard Access Systems is recalling 4,500 units of StatLock IV Premium Catheter Stabilization Devices because they may contain incorrectly sized retainer clips.

    Product
    StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2124-2017·2017-05-31

    Beckman Coulter Recalls Microalbumin Reagent Due to Potential Out-of-Range Recovery

    Beckman Coulter is recalling Microalbumin Reagent Lot M609458 because it may recover outside the lower limit of the published insert range for Urine Protein Control Level 1.

    Product
    Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0840-2017·2017-05-31

    Advanced Pharma Recalls Atropine Sulfate for Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Atropine Sulfate because the product may contain latex but lacks appropriate labeling.

    Product
    Atropine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0837-2017·2017-05-31

    Advanced Pharma Recalls Esmolol HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all Esmolol HCl products because the labeling does not indicate that the products may contain synthetic or natural latex.

    Product
    Esmolol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·057-2017·2017-05-27

    Readfield Meats Recalls Beef Trimming Products Due to Possible Adulteration

    Readfield Meats is recalling approximately 45,985 pounds of beef trimming products because they were distributed to non-federally inspected establishments where sufficient further processing could not be verified.

    Product
    Dominion Foods Group LLC — Readfield Meats, Inc. Recalls Beef Trimming Products Due to Possible Adulteration
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2083-2017·2017-05-24

    Beckman Coulter Recalls Triglycerides Reagent Due to Interference

    Beckman Coulter is recalling Triglycerides Reagent because specific drugs can cause false low results.

    Product
    Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative determination of triglycerides concentration in human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-2224-2017·2017-05-24

    Kemps Recalls Frozen Yogurt and Ice Cream Due to Plastic Contamination

    Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.

    Product
    Kemps YO2 Frozen Yogurt Salty Caramel Cookie Crunch, One Pint, UPC 41483-04123
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Food)·F-2234-2017·2017-05-24

    Kemps Recalls Sweet Me Creamery Ice Cream and Frozen Yogurt for Plastic

    Kemps, LLC is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.

    Product
    Kemps Sweet Me Creamery Maple Toffee Blondie, One Pint, UPC 41483-04146
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Food)·F-2239-2017·2017-05-24

    Herbalife Recalls Peanut Butter Protein Bars Due to Fish Gelatin

    Herbalife is recalling Peanut Butter Protein Bars because they may contain trace amounts of fish gelatin, an undeclared allergen.

    Product
    Protein Bar 14 bars/box, Net Wt. 19.74oz (560g) Each shipping carton contains 12 boxes
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2084-2017·2017-05-24

    Beckman Coulter Recalls Salicylate Reagent Due to Drug Interference

    Beckman Coulter is recalling Salicylate Reagent (Catalog No. 378194) because specific drugs can cause false low results in salicylate testing.

    Product
    Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateUSDA FSIS·054-2017·2017-05-24

    Armour Eckrich Recalls Sausage Due to Possible Metal Contamination

    Armour Eckrich Meats is recalling approximately 90,978 pounds of ready-to-eat sausage products that may contain pieces of metal. No adverse reactions have been reported.

    Product
    Armour Eckrich Meats, LLC Recalls Ready-To-Eat Sausage Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0790-2017·2017-05-24

    Taro Recalls Fluocinonide Cream Due to Hydrocortisone Contamination

    Taro Pharmaceuticals is recalling specific lots of Fluocinonide Cream 0.05% due to cross-contamination with hydrocortisone-17-valerate.

    Product
    FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2075-2017·2017-05-24

    Zimmer CAS Recalls Navitrack System Knee Instrument Due to Software Anomalies

    Zimmer CAS is voluntarily recalling 152 units of the Navitrack System - OS Knee Universal due to software anomalies corrected in a new revision.

    Product
    Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-2085-2017·2017-05-24

    Siemens Recalls Insulin Calibrators Due to Measurement Deviation

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems Insulin Calibrators because they measure approximately 40% higher than the WHO standard.

    Product
    ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2104-2017·2017-05-24

    Medline Recalls Distraction Pins Due to Potential Sterility Loss

    Medline Industries is recalling 2,112 packs of sterile distraction pins because the packaging seal may be compromised, risking loss of sterility.

    Product
    16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2081-2017·2017-05-24

    Beckman Coulter Cholesterol Reagent Recalled for Potential Drug Interference

    Beckman Coulter is recalling Cholesterol Reagent (Catalog No. 467825) because specific drugs may cause false low results.

    Product
    Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2107-2017·2017-05-24

    Medline 12 mm Distraction Pin Recalled for Potential Sterility Loss

    Medline Industries is recalling 300 packs of 12 mm Distraction Pins because the sterile packaging seal may be compromised, potentially allowing the device to lose sterility.

    Product
    12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2073-2017·2017-05-24

    Biomet Microfixation Recalls Surgical Trays Due to Part Number Mismatch

    Biomet Microfixation is recalling 33 TraumaOne System Surgical Trays because the part number on the lid differs from the base.

    Product
    Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
    Category
    Medical Device
    Distribution
    3 states