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.

9926–9950 of 21617

  • ModerateFDA (Devices)·Z-0095-2019·2018-10-17

    GE Healthcare CARESCAPE Monitor B450 Recalled for Network-Related Restart Issues

    GE Healthcare is recalling CARESCAPE Monitor B450 units because they may restart simultaneously and fail to complete the process if connected to an overloaded network.

    Product
    GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0092-2019·2018-10-17

    Stryker Spine AVS Aria Cage Recalled for Incorrect Marker Placement

    Stryker Spine is recalling five AVS Aria Cage units because the anterior and posterior markers were placed on the incorrect sides of the device.

    Product
    AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0011-2019·2018-10-17

    Jubilant Cadista Recalls Pantoprazole Tablets Due to Dark Discoloration

    Jubilant Cadista Pharmaceuticals is recalling 158,466 bottles of 40 mg pantoprazole sodium delayed-release tablets due to dark discoloration or brown spots on the edges.

    Product
    Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0010-2019·2018-10-17

    Pfizer Recalls Glipizide XL Tablets Due to Manufacturing Deviations

    Pfizer is recalling 7,777 bottles of Glipizide XL 5 mg tablets because rejected product was used in manufacturing, violating CGMP standards.

    Product
    Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0096-2019·2018-10-17

    GE Healthcare CARESCAPE Monitor B850 Recalled for Network-Related Restart Issues

    GE Healthcare is recalling CARESCAPE Monitor B850 units because they may simultaneously restart during prolonged network overload, preventing the restart from completing until the network issue is corrected.

    Product
    GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facili
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0088-2019·2018-10-17

    GSK Recalls Prevacid 24HR Capsules Due to Manufacturing Deviations

    GSK is voluntarily recalling Prevacid 24HR capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations. No illnesses have been reported.

    Product
    Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0013-2019·2018-10-17

    Syntec Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

    Syntec Pharma Corp is recalling 5 KG bags of Thyroid Powder USP because the active ingredients levothyroxine and liothyronine have inconsistent levels.

    Product
    THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient; 5 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0076-2019·2018-10-17

    AngioDynamics BioFlo Port Recall Due to Incorrect Sterile Assembly

    AngioDynamics is recalling BioFlo Ports that were partially manufactured with the wrong sterile port assembly. The devices were distributed in Indiana.

    Product
    BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0077-2019·2018-10-17

    Instrumentation Laboratory Recalls HemosIL ReadiPlasTin Diagnostic Reagent

    Instrumentation Laboratory is recalling 9,751 kits of HemosIL ReadiPlasTin due to potential imprecision and out-of-range quality controls.

    Product
    Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0089-2019·2018-10-17

    Implant Direct Legacy Implant Closed-Tray Transfer Mislabeled Cap Recall

    Implant Direct is recalling 217 units of Legacy Implant Closed-Tray Transfer components due to potential cap mislabeling. The correct part number is on the main vial label.

    Product
    Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0021-2019·2018-10-17

    Hodgson Mill Gluten Free Cookie Mix Recalled for Ingredient Labeling Errors

    Hodgson Mill is recalling 707 cases of Gluten Free Cookie Mix because the packaging lists incorrect ingredients, omitting amaranth flour and baking soda while including baking powder and vanilla.

    Product
    Hodgson Mill Cookie Mix Gluten Free 12oz. cardboard carton retail unit; 6 retail units per case. UPC Code 0 71518 02125 2
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-0026-2019·2018-10-17

    Takeda Recalls Actoplus met XR Tablets Due to Defective Delivery System

    Takeda is recalling Actoplus met XR tablets because the laser-drilled holes on the metformin core may be missing, potentially affecting drug delivery.

    Product
    Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30
    Category
    Drug
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0014-2019·2018-10-17

    Syntec Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

    Syntec Pharma Corp is recalling 486 kg of Thyroid Powder USP because the active ingredients levothyroxine and liothyronine have inconsistent levels.

    Product
    THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 8.1-9.9mcg/grain) active pharmaceutical ingredient; 25 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hon
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0012-2019·2018-10-17

    InvaGen Recalls Amlodipine Besylate Tablets Due to Subpotency

    InvaGen Pharmaceuticals is recalling one lot of Amlodipine Besylate 10 mg tablets because the product failed to meet assay specifications at 3-month stability conditions.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·090-2018·2018-10-11

    Valley Fine Foods Recalls Meat and Poultry Products Due to Spoilage

    Valley Fine Foods is recalling approximately 35,516 pounds of heat-treated meat and poultry products that may be adulterated with spoilage organisms.

    Product
    Valley Fine Foods Recalls Meat and Poultry Products due to Possible Adulteration
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0046-2019·2018-10-10

    Oridion Capnostream20 M NICU Monitors Recalled for Settings Reset

    Oridion Medical is recalling 262 Capnostream20 M NICU monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 M NICU (CPM), CS08654RN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0027-2019·2018-10-10

    Oridion Capnostream 20P Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 696 Capnostream 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0028-2019·2018-10-10

    Oridion Capnostream20 Bedside Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 769 Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M, Part Number CS08653
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0058-2019·2018-10-10

    Ortho VITROS Folate Reagent Pack Recall for Biotin Interference

    Ortho Clinical Diagnostics is recalling VITROS Folate Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated.

    Product
    VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0045-2019·2018-10-10

    Oridion Capnostream20 M Adult ICU Monitors Recalled for Settings Reset

    Oridion Medical is recalling five Capnostream20 M Adult ICU monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 M ADULT ICU (CPM), CS08654RA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0001-2019·2018-10-10

    Teva Recalls Clozapine Tablets Due to Failed Disintegration Testing

    Teva Pharmaceuticals is recalling 313 bottles of Clozapine 12.5 mg tablets because routine stability testing showed the tablets failed to disintegrate as required.

    Product
    CLOZAPINE — CLOZAPINE (CLOZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0009-2019·2018-10-10

    Endo Pharmaceuticals Recalls Robaxin-750 Due to Incorrect Dosage Labeling

    Endo Pharmaceuticals is recalling 2,856 bottles of Robaxin-750 (methocarbamol) because the labels contain incorrect dosage instructions.

    Product
    robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0054-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling eight refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0047-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 23 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) M W/PRINTER, CS08660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0007-2019·2018-10-10

    Dr. Reddy's Recalls Nystatin and Triamcinolone Cream for Stability Failures

    Dr. Reddy's Laboratories is recalling Nystatin and Triamcinolone Acetonide Cream because stability testing showed out-of-specification results for Nystatin composition.

    Product
    Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ -
    Category
    Drug
    Distribution
    Distributed nationwide