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.

6401–6425 of 21595

  • ModerateFDA (Devices)·Z-3044-2020·2020-10-07

    Ameditech Recalls TDDA Drugs of Abuse Cups Due to Performance Failures

    Ameditech Inc is recalling TDDA Drugs of Abuse Cups because the immunoassay enzymes failed to consistently detect all compounds at labeled levels.

    Product
    TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G."
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0032-2021·2020-10-07

    Hale & Hearty Wild Mushroom Barley Soup Recalled for Maggots

    Hale And Hearty Soups, LLC is recalling 174 bags of Wild Mushroom Barley soup because the product may contain pieces of maggots.

    Product
    WILD MUSHROOM BARLEY soup; Manufactured By: Hale & Hearty Soups; 2x9.6lbs; 13.8 net weight; Keep Refrigerated
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-3031-2020·2020-10-07

    Ameditech Recalls Alere iCup Drug Detection Cups Due to Performance Failures

    Ameditech Inc is recalling Alere iCup Drug Detection cups because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.

    Product
    Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3048-2020·2020-10-07

    Ameditech Recalls First Check 2 Panel Drug Cups Due to Performance Failures

    Ameditech is recalling 41,340 units of First Check 2 Panel Drug Cups because the products failed to consistently detect compounds at labeled levels.

    Product
    First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3051-2020·2020-10-07

    Ameditech Drug Screening Components Recalled for Performance Failures

    Ameditech Inc is recalling specific drug screening components because they failed to consistently detect compounds at labeled levels.

    Product
    Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Shee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1591-2020·2020-09-30

    Yacana Alcohol Antiseptic Recalled for cGMP Deviations in Texas

    Grupo Yacana Mexico is voluntarily recalling 43,728 bottles of Yacana Alcohol Antiseptic 70% Topical Solution distributed in Texas due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3011-2020·2020-09-30

    Irvine Biomedical Recalls Steerable Diagnostic Catheters Due to Labeling Error

    Irvine Biomedical is recalling 15 units of Inquiry Steerable Diagnostic Catheters because packages were mislabeled with the wrong model and batch numbers.

    Product
    Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1590-2020·2020-09-30

    Yacana Alcohol Antiseptic Recalled for cGMP Deviations in Texas

    Grupo Yacana Mexico is voluntarily recalling 55,560 bottles of Yacana Alcohol Antiseptic 70% Topical Solution distributed in Texas due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave. Alfonso reyes 714 Col. Contry La Silla, Monterrey, Nuevo Leon, Mexico Tel. +52 812473-8453, NDC # 76592-002-04, UPC 6 03765 37699 3
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3006-2020·2020-09-30

    Beckman Coulter Access Unconjugated Estriol Assay Systems Recalled for Interference

    Beckman Coulter is recalling Access Unconjugated Estriol assay systems because alkaline phosphatase interference may cause falsely elevated results.

    Product
    BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2997-2020·2020-09-30

    GE Healthcare Recalls Discovery NM670 Pro Due to Loose Screws

    GE Healthcare is recalling nine Discovery NM670 Pro units because rotor bearing screws were found loose on the detector.

    Product
    Discovery NM670 Pro Model # H3100XB
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-1621-2020·2020-09-30

    Preferred Pharmaceuticals Recalls Nature-Throid Tablets Due to CGMP Deviations

    Preferred Pharmaceuticals is voluntarily recalling Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected repackaged tablets were sold to three physicians in California and Georgia.

    Product
    Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-9283-01
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2982-2020·2020-09-30

    Bio-Rad Recalls BioPlex 2200 Syphilis Assay Due to Increased Reactivity

    Bio-Rad is recalling BioPlex 2200 Syphilis Total & RPR kits because of increased RPR reactivity levels in the kit material.

    Product
    BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-trepo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1624-2020·2020-09-30

    Preferred Pharmaceuticals Recalls Nature-Throid Tablets Due to Manufacturing Deviations

    Preferred Pharmaceuticals is voluntarily recalling Nature-Throid tablets due to CGMP deviations. The affected repackaged tablets were sold to three physicians in California and Georgia.

    Product
    Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg, 90-count bottles, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-7605-09
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1622-2020·2020-09-30

    Preferred Pharmaceuticals Recalls Nature-Throid Tablets Due to CGMP Deviations

    Preferred Pharmaceuticals is recalling specific lots of Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected repackaged tablets were sold to three physicians in California and Georgia.

    Product
    Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-6860-09
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2983-2020·2020-09-30

    Beckman Coulter Recalls DxA 5000 Automated Sample Handling Systems

    Beckman Coulter is recalling 32 DxA 5000 automated sample handling systems because the instructions for use may be confusing regarding the re-use of sample IDs, leading to undetected barcode re-use.

    Product
    DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents samp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1592-2020·2020-09-30

    Zanilast+ Hand Sanitizer Recalled for Potential 1-Propanol Contamination

    Nanomateriales S.A. de C.V. is recalling Zanilast+ Gel Antiseptic Hand Sanitizer due to GMP deviations that may result in the presence of 1-propanol.

    Product
    Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 531151); b) 1 gal (3.76L) (NDC 69912-008-02 UPC 2 000000 531144) bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Ca
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Food)·F-1539-2020·2020-09-30

    Cedar's Cucumber Garlic Dill Tzatziki Recalled for Undeclared Ingredients

    Cedar's Mediterranean Foods is recalling 3,426 units of Cucumber Garlic Dill Tzatziki because the product contains undeclared Food Starch, Gelatin, and Natamycin.

    Product
    Cedar's Cucumber Garlic Dill Tzatziki, 12 oz packaged in clear plastic tubs; Made with GREEK YOGURT; INGREDIENTS: CULTURED PASTEURIZED NONFAT MILK, CULTURED PASTEURIZED CREAM, MILK PROTEIN CONCENTRATE, STABILIZER (TAPIOCA STARCH, AGAR-AGAR, PECTIN), CUCUMBER, GARLIC, SEA SALT, OR
    Category
    Food
    Distribution
    5 states
  • ModerateNHTSA·20V584000·2020-09-24

    2021 International MV and HV trucks missing required reflective tape

    Navistar is recalling 2021 International MV and HV trucks that may lack reflective tape on the cab, required by federal safety standards. Without it, trucks are less visible at night, increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL MV, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·20V586000·2020-09-24

    Incorrect Tire Pressure Labels on 2020-2021 Land Rover Range Rover Sport

    Certain 2020-2021 Land Rover Range Rover Sport vehicles with 19-inch wheels have incorrect tire pressure information on their labeling. This could lead to improper tire inflation and loss of vehicle control.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2967-2020·2020-09-23

    Tosoh Bioscience Recalls AIA-PACK HCG Calibrator Sets Due to Stability Issues

    Tosoh Bioscience is recalling five lots of AIA-PACK HCG Calibrator Sets because decreased stability may cause measured HCG concentrations to be up to 20% lower than actual.

    Product
    Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2981-2020·2020-09-23

    Roche Recalls Anti-TPO Assay Kits Due to Updated Interference Claim

    Roche Diagnostics is recalling 11,870 Elecsys Anti-TPO Assay kits because internal studies found the radio frequency interference claim no longer met for specific cobas e analyzers.

    Product
    Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
    Category
    Medical Device
    Distribution
    Distributed nationwide