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.

6426–6450 of 21595

  • ModerateFDA (Food)·F-1522-2020·2020-09-23

    Herr's Potato Chips Recalled for Undeclared Allergens and Ingredients

    Herr Foods Inc is recalling GameDay Tailgate Tacos Flavored Potato Chips due to undeclared black bean powder, jalapeno pepper powder, paprika, and other ingredients.

    Product
    Herr s GameDay Tailgate Tacos Flavored Potato Chips 6.5 oz. packaged in a flexible metalized bag. UPC Code: 7260006434
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2968-2020·2020-09-23

    Tosoh Bioscience Recalls AIA-PACK BHCG Calibration Sets Due to Stability Issues

    Tosoh Bioscience is recalling 39 boxes of AIA-PACK BHCG Calibration Sets due to decreased stability that may cause inaccurate HCG concentration measurements.

    Product
    Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 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-2963-2020·2020-09-23

    Randox Lactate Dehydrogenase Reagent Recall for Carryover Avoidance

    Randox Laboratories is recalling Lactate Dehydrogenase P-L reagent to address reagent carryover issues on RX instruments that may cause erroneous test results.

    Product
    Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX dayt
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2962-2020·2020-09-23

    Randox Lactate Dehydrogenase Reagent Recalled for Carryover Avoidance Steps

    Randox Laboratories is recalling Lactate Dehydrogenase reagents to update technical bulletins with additional pipette wash steps to prevent reagent carryover and erroneous test results.

    Product
    Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1609-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions found to be subpotent. The recall covers lots expiring between October 2020 and July 2023.

    Product
    WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5750-2 ; b) 30 Tablets, NDC 64727-5750-4; c) 60 Tablets, NDC 64727-5750-5; d) 90 Tablets, NDC 64727-5750-6; e) 100 Tablets, NDC 64727-5750-1; Rx only, Manufactured by: RLC Labs Phoeni
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1612-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions associated with subpotent products.

    Product
    WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-6150-2 ; b) 30 Tablets, NDC 64727-6150-4; c) 60 Tablets, NDC 64727-6150-5; d) 90 Tablets, NDC 64727-6150-6; e) 100 Tablets, NDC 64727-6150-1; Rx only, Manufactured by: RLC Labs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1604-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets because they were manufactured under conditions associated with subpotency. The recall covers all lots with expiry dates between October 2020 and July 2023.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg], 2.5 Grain (162.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3310-4; b) 60-count bottles, NDC 64727-3310-5; c) 90-count bottles, NDC 64727-3310-6; d) 100-count bottles, NDC 64727-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1599-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The product was manufactured under conditions found to be subpotent.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 11.25 mcg and levothyroxine (T4) 47.5 mcg], 1.25 Grain (81.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3303-4; b) 60-count bottles, NDC 64727-3303-5; c) 90-count bottles, NDC 64727-3303-6; d) 100-count bottles, NDC 647
    Category
    Drug
    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 (Drugs)·D-1610-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions found to be subpotent. The recall covers lots expiring between October 2020 and July 2023.

    Product
    WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-6050-2 ; b) 30 Tablets, NDC 64727-6050-4; c) 60 Tablets, NDC 64727-6050-5; d) 90 Tablets, NDC 64727-6050-6; e) 100 Tablets, NDC 64727-6050-1; Rx only, Manufactured by: RLC Labs P
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2958-2020·2020-09-23

    Boston Scientific Recalls Mislabeled WallFlex Biliary Stent Systems

    Boston Scientific is recalling 40 units of WallFlex Biliary RX stents that were mislabeled as fully covered devices. The error involves the 10mm x 60mm size.

    Product
    WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1598-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets due to manufacturing deviations. The products were manufactured under conditions found to be subpotent.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg], 1/2 Grain (32.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3299-4; b) 60-count bottles, NDC 64727-3299-5; c) 90-count bottles, NDC 64727-3299-6; d) 100-count bottles, NDC 64727-3299
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2980-2020·2020-09-23

    Medtronic Guardian Connect iOS App Recall Due to Data Upload Failure

    Medtronic is recalling the Guardian Connect iOS app because a software update stopped automatic data uploads to the CareLink Personal website.

    Product
    The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1602-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets because they were manufactured under conditions found to be subpotent.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg and levothyroxine (T4) 76 mcg], 2 Grain (130 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3308-4; b) 60-count bottles, NDC 64727-3308-5; c) 90-count bottles, NDC 64727-3308-6; d) 100-count bottles, NDC 64727-3308-1;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2959-2020·2020-09-23

    Terumo Ultrasonic Air Sensor Recall Due to Intermittent Connection

    Terumo is recalling 100 Ultrasonic Air Sensors because a manufacturing defect may cause false air bubble alarms during extracorporeal procedures.

    Product
    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1508-2020·2020-09-23

    Coolhaus Ice Cream Sandwich Recalled for Undeclared Soy Lecithin

    Coolhaus is recalling specific lots of 'That Dough Though' ice cream sandwiches because the package label does not declare soy lecithin.

    Product
    Coolhaus Awesome Ice Cream -That Dough Though Ice Cream Sandwich; Chocolate chip cookies, cookie dough batter with gobs of cookie dough. Keep Frozen Contains: Milk, Wheat, Eggs 5.8 oz . serve package - polypropylene film wrapper. UPC: 8 51916 00349 0 Coolhaus, Culver
    Category
    Food
    Distribution
    15 states
  • 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
  • ModerateFDA (Drugs)·D-1605-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets because they were manufactured under conditions associated with subpotent products.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 114 mcg], 3 Grain (195 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3312-4; b) 60-count bottles, NDC 64727-3312-5; c) 90-count bottles, NDC 64727-3312-6; d) 100-count bottles, NDC 64727-3312-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2971-2020·2020-09-23

    Cook Medical Recalls Universa Soft Ureteral Stent Sets Due to Packaging Error

    Cook Inc. is recalling 20 units of Universa Soft Ureteral Stent Sets because they were incorrectly placed in boxes labeled for the Firm version.

    Product
    Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2937-2020·2020-09-16

    Hager & Meisinger Recalls Dental Burs Due to Labeling Discrepancy

    Hager & Meisinger is recalling 144 units of SINGLES Carbide dental burs because the US dates on the package label do not match the bar code display.

    Product
    SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1425-2020·2020-09-16

    Culinary Collective Recalls Blanxart Chocolate Bars Due to Foreign Object

    Culinary Collective is recalling Blanxart 82% Congo Organic Chocolate Bars because a consumer found a foreign object in the product.

    Product
    Blanxart 82% Congo Organic Chocolate Bar. Paper packaging with internal foil wrapper. Net weight per bar: 4.4 oz. UPC 8 32924 00032 9. The product label is read in parts: "***BLANXART *** ORGANIC DARK CHOCOLATE 82% CONGO ***Ingredients: cocoa, cocoa butter, sugar, vanilla ***I
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1562-2020·2020-09-16

    Edge Pharma Recalls Vancomycin IV Bags Due to Labeling Error

    Edge Pharma, LLC is recalling Vancomycin HCL 1.5 mg IV bags distributed in Wisconsin due to a label error regarding the declared strength.

    Product
    Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1566-2020·2020-09-16

    Teva Recalls Cephalexin Oral Suspension Due to Low Potency

    Teva Pharmaceuticals is recalling Cephalexin for Oral Suspension because test results showed the drug was below the required potency specification.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2945-2020·2020-09-16

    Smith & Nephew Recalls EVOS Screws Due to Incorrect Expiration Dates

    Smith & Nephew is recalling 71 units of EVOS Screws because the labels contain multiple or incorrect expiration dates.

    Product
    EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    0 states