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.

3626–3650 of 21589

  • ModerateFDA (Drugs)·D-0483-2023·2023-04-05

    Drug Recall: Simvastatin 5 mg tablets due to manufacturing compliance violations

    Direct Rx is recalling 51 bottles of Simvastatin 5 mg tablets nationwide due to Good Manufacturing Practice deviations. The recall is voluntary and was initiated in March 2023.

    Product
    Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1298-2023·2023-04-05

    Medical device lysis beads recalled for misleading label statements

    Entopsis recalls PCRopsis Lysis Beads (363 units) due to misleading label statements on the product packaging. The affected product was distributed nationwide and to Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania.

    Product
    PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2023·2023-04-05

    Simvastatin Tablets Recalled Nationwide Over Manufacturing Practice Deviations

    Direct Rx is recalling 269 bottles of Simvastatin 40 mg nationwide due to Good Manufacturing Practice deviations. No adverse events have been reported. Consult your healthcare provider before changing your medication.

    Product
    Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1297-2023·2023-04-05

    PCRopsis Activator nucleic acid extraction kits recalled for misleading labels

    Entopsis, Inc. is recalling PCRopsis Activator nucleic acid extraction kits due to misleading label statements. The products were distributed nationwide and internationally.

    Product
    PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2023·2023-04-05

    Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations

    Direct Rx is recalling Montelukast Sodium 10 mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects approximately 508 bottles distributed across the United States.

    Product
    Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1305-2023·2023-04-05

    ACL ELITE PRO-Analyzer: HemosIL Liquid Anti-Xa test definition removed

    Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL ELITE/Elite Pro analyzers used in clinical hemostasis laboratories. No illnesses or injuries have been reported.

    Product
    ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0671-2023·2023-04-05

    Rakkyo (scallions) recalled due to incorrect ingredients statement

    Lemonland Food Corp recalled Rakkyo (scallions) distributed in Washington because the ingredients statement label required correction. The product contains no allergens.

    Product
    Rakkyo (scallions) distributed in un-labeled plastic containers 8oz and/or 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1317-2023·2023-04-05

    Shoulder Glenoid Prosthesis Implant Manufactured Without Tantalum Markers

    A shoulder glenoid prosthesis implant (SMR TT Hybrid Std - Peg S) was manufactured without tantalum markers that aid in radiographic visualization. While alternative assessment methods using joint space, peg position, and cement observation remain available, the missing markers limit direct imaging capabilities.

    Product
    SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0482-2023·2023-04-05

    Glimepiride tablet recall due to manufacturing practice deviations

    Direct Rx is recalling Glimepiride 4 mg tablets nationwide due to manufacturing process deviations. The recall is voluntary and affects specific lots of 30-count and 90-count bottles.

    Product
    Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0477-2023·2023-04-05

    Finasteride Tablets Recalled Nationwide for Manufacturing Practice Deviations

    Direct Rx is recalling 19 bottles of Finasteride 5 mg Tablets nationwide due to cGMP deviations. The firm initiated this recall voluntarily.

    Product
    Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1301-2023·2023-04-05

    PCRopsis Support Medical Device Recall Due to Misleading Label Statements

    Entopsis, Inc. is recalling PCRopsis Support nucleic acid extraction reagents due to misleading statements on product labels. No illnesses or injuries have been reported.

    Product
    PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1299-2023·2023-04-05

    PCR Reagent Recalled for Misleading Label Statements

    Entopsis, Inc. is recalling 397 units of PCRopsis Reagent RVD with RVD Enhancer due to misleading label statements. The affected products were distributed nationwide and internationally.

    Product
    PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·23172·2023-03-31

    The Laundress Fabric Conditioners Recalled for Ethylene Oxide Contamination

    The Laundress is recalling about 800,000 fabric conditioner products sold nationwide from 2011 through November 2022 because they may contain ethylene oxide, a chemical carcinogen. Consumers should stop using the products immediately and contact The Laundress for a refund.

    Product
    The Laundress Fabric Conditioners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23171·2023-03-30

    Carhartt Men's Work Pants Recalled for Fall Hazard from Hem Loop

    Carhartt Men's Force Relaxed 5 Pocket Work Pants can develop an extended elastic loop at the ankle that poses a trip and fall hazard. About 32,505 units sold at Dick's Sporting Goods from July through November 2022 are affected.

    Product
    Carhartt Men's Force Relaxed 5 Pocket Work Pants
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23168·2023-03-30

    Open Cycle Bicycles Recalled Due to Rear Brake Failure Hazard

    Open Cycle UP Ekar, UPPER Ekar, WIDE Ekar, and MIND Ekar bicycles with Campagnolo hydraulic rear disc brakes are being recalled because the rear brake can fail, posing a crash hazard. About 270 units sold nationwide from November 2021 through February 2023 are affected.

    Product
    Open Cycle UP Ekar, UPPER Ekar, WIDE Ekar and MIND Ekar bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0624-2023·2023-03-29

    Haiyue Preserved Vegetable Product Recalled for Unauthorized Food Additive

    Haiyue Food Nutritional Preserved Vegetable is recalled because it contains cyclamate, an unauthorized food additive in the United States. The FDA Class III recall affects 55 boxes distributed in New York, North Carolina, Florida, and Indiana.

    Product
    Haiyue Food Nutritional Preserved Vegetable
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0470-2023·2023-03-29

    Daytrana Methylphenidate Patches Recalled for Defective Delivery System

    Noven Pharmaceuticals is recalling specific lots of Daytrana methylphenidate transdermal patches distributed nationwide because the delivery system is out of specification for shear. The affected lots require patient and healthcare provider attention.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2023·2023-03-29

    Contact Lens Recall: CooperVision Clariti 1-day Toric With Incorrect Power

    CooperVision is recalling Clariti 1-day toric contact lenses from lot W0124677 because they were made with a misaligned axis that results in incorrect lens power.

    Product
    Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0474-2023·2023-03-29

    Dofetilide Capsules Recalled for Failed Content Uniformity Specifications

    Sun Pharmaceutical is recalling 1,920 bottles of Dofetilide Capsules (500 mcg) nationwide due to failed content uniformity specifications, meaning the capsules do not contain uniform amounts of active ingredient.

    Product
    Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1283-2023·2023-03-29

    DeRoyal Suction Canister Recalled Due to Lid Shrinkage Seal Defect

    DeRoyal SafeLiner Suction Canister model PHESL-1000B is being recalled due to lid shrinkage that prevents proper vacuum seal formation and maintenance. The recall affects 27,200 devices distributed across multiple US states.

    Product
    DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·23738·2023-03-23

    Burnham Commercial Natural Gas Boilers Recalled for Burn Hazard

    Burnham Commercial is recalling about 185 commercial natural gas boilers because delayed ignition and flame rollout can occur, posing a burn hazard. Two flame rollouts have been reported, but no injuries.

    Product
    Burnham Commercial Natural Gas Boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0603-2023·2023-03-22

    Cafe' Intermezzo Traditional Cheesecake recalled for incomplete sub-ingredient disclosure

    Epic Baking recalled 323 units of Cafe' Intermezzo Traditional Cheesecake distributed in Georgia and Tennessee for failure to list sub-ingredients on the label. All major allergens are disclosed in the product's contains statement.

    Product
    Cafe' Intermezzo Traditional Cheesecake 5.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Graham Cracker Crust (Graham Cracker Crumbs, Butter, Sugar, Vanilla Extract, Cinnamon), Vanilla Extract, Corn Starch Contains: Milk, eggs, wheat, and soy, May contain tree nuts and peanuts.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0465-2023·2023-03-22

    Buprenorphine Transdermal System Recalled for Failed Impurity Specifications

    AVEVA Drug Delivery Systems recalls nationwide batches of Buprenorphine Transdermal patches due to a degradation impurity exceeding acceptable limits during stability testing.

    Product
    Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0425-2023·2023-03-22

    Dietary Supplement Sub-Potency Recall: Healthy Sense Daily Multiple with Iron

    Mason Vitamins is recalling Healthy Sense Daily Multiple with Iron dietary supplements because the product contains insufficient levels of Vitamins A, B12, B5, C, and E compared to label claims.

    Product
    Healthy Sense Daily Multiple with Iron, Dietary Supplement, 20 Tablets
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1253-2023·2023-03-22

    In Vitro Diagnostic GI Panel Recalled Due to Temperature Exposure During Shipping

    BioFire Diagnostics is recalling FilmArray GI Panel diagnostic kits due to temperature excursions during shipping that may reduce test performance.

    Product
    In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
    Category
    Medical Device
    Distribution
    Distributed nationwide