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.

9251–9275 of 21595

  • ModerateFDA (Food)·F-1262-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods is recalling 20,150 lbs of Commercial Breader Batter because it may contain small pieces of plastic. The product was distributed to commercial processors in 14 states.

    Product
    Commercial Breader Batter; #22419 BATTER MX X2; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Food)·F-1247-2019·2019-04-17

    Newly Weds Foods Recalls Commercial Breader Batter Due to Plastic Contamination

    Newly Weds Foods Inc is recalling 12,800 lbs of Commercial Breader Batter because it may contain small pieces of plastic. The product was distributed to commercial processors in 14 states.

    Product
    Commercial Breader Batter; A80261 BATTER MX X1; 50 pound bag
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-1079-2019·2019-04-10

    KRS Global Biotechnology Recalls NORepinephrine IV Bags Due to Labeling Error

    KRS Global Biotechnology is recalling 433 bags of NORepinephrine 4 mg in 5% Dextrose due to a label mix-up. The product was distributed nationwide.

    Product
    NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1074-2019·2019-04-10

    Abbott Recalls CELL-DYN Emerald Analyzers Due to Quality Control Errors

    Abbott Laboratories is recalling 6,353 CELL-DYN Emerald analyzers worldwide because they may generate incorrect low quality control results for red blood cells and platelets.

    Product
    CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·045-2019·2019-04-10

    Yoakum Packing Recalls Venison Sausage Due to Pork Mislabeling

    Yoakum Packing Co. is recalling smoked venison sausage that contains pork not listed on the label. The recall affects products sold in Texas.

    Product
    Yoakum Packing Co. — Yoakum Packing Co. Recalls Venison Sausage Products Due to Mislabeling
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1071-2019·2019-04-10

    Pfizer Recalls Clindamycin Injection Due to Impurity Specification Failures

    Pfizer is recalling specific lots of Clindamycin Injection because high out-of-specification impurities were found at the 24-month time point.

    Product
    Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1083-2019·2019-04-10

    Advanced Bionics Recalls Four Naída CL Q30 Sound Processors

    Advanced Bionics is recalling four Naída CL Q30 sound processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.

    Product
    Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1072-2019·2019-04-10

    Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures

    Pfizer is recalling specific lots of Clindamycin Injection due to high out-of-specification impurity results at the 24-month time point.

    Product
    Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1078-2019·2019-04-10

    KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Labeling Error

    KRS Global Biotechnology is recalling 190 bags of Repinephrine 16 mg IV solution due to a label mix-up. The product was distributed nationwide.

    Product
    NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1230-2019·2019-04-10

    Snow's Mint Chip Ice Cream Recalled for Undeclared Yellow #5 Dye

    Snow's Acquisition, LLC is recalling Mint Chip Ice Cream with Dark Chocolate Chunks because the product contains undeclared Yellow #5 dye.

    Product
    Snow's PREMIUM ICE CREAM Mint Chip Mint Ice Cream with Dark Chocolate Chunks 1.5 QUART (1.42L) KEEP FROZEN, UPCE: 0 48896400139
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1069-2019·2019-04-10

    Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures

    Pfizer is recalling specific lots of Cleocin Phosphate injection because high levels of impurities were found at the 24-month time point.

    Product
    CLEOCIN PHOSPHATE — CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1085-2019·2019-04-10

    Advanced Bionics Recalls Naída CI Q90 Sound Processor Due to Firmware Error

    Advanced Bionics is recalling one Naída CI Q90 Sound Processor because it was loaded with incorrect firmware. The device was distributed in North Carolina and several foreign countries.

    Product
    Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1070-2019·2019-04-10

    Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures

    Pfizer is recalling specific lots of Clindamycin Injection because high levels of impurities were found at the 24-month time point.

    Product
    Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1075-2019·2019-04-10

    Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues

    Abbott Laboratories is recalling specific lots of ARCHITECT Creatine Kinase IVD kits due to a stability issue that may cause error codes or out-of-range quality control results.

    Product
    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1079-2019·2019-04-10

    Conformis Recalls Two iTotal Knee Replacement Systems for Labeling Errors

    Conformis, Inc. is recalling two iTotal Posterior Stabilized Knee Replacement Systems because the box and sterile pouch labels did not match the contents.

    Product
    iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1084-2019·2019-04-10

    Advanced Bionics Recalls Three Naída CI Q70 Sound Processors

    Advanced Bionics is recalling three Naída CI Q70 Sound Processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.

    Product
    Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1076-2019·2019-04-10

    Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues

    Abbott Laboratories is recalling 30 kits of ARCHITECT Creatine Kinase IVD due to a stability issue that may cause error codes or out-of-range quality control results.

    Product
    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1074-2019·2019-04-10

    Jubilant Cadista Recalls Pantoprazole Sodium Tablets Due to Discoloration

    Jubilant Cadista Pharmaceuticals is recalling 12,960 bottles of Pantoprazole Sodium Delayed-Release Tablets due to dark brown discoloration on the tablet 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-1076-2019·2019-04-10

    Pacific Compounding Recalls Cefuroxime Injection Due to Particulate Matter

    Pacific Compounding Pharmacy is recalling one lot of Cefuroxime injection because FDA analysis found rubber stopper fragments in the product.

    Product
    Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
    Category
    Drug
    Distribution
    1 state
  • ModerateUSDA FSIS·043-2019·2019-04-08

    JBS Plainwell Recalls Ground Beef Products Due to Possible Plastic Contamination

    JBS Plainwell is recalling approximately 43,292 pounds of ground beef products sold in Michigan and Wisconsin that may contain pieces of hard plastic.

    Product
    JBS Plainwell, Inc. — JBS Plainwell, Inc. Recalls Ground Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1241-2019·2019-04-03

    Kroger Recalls 16 oz Quinoa Packages for Possible Pesticide Contamination

    The Kroger Company is recalling 16 oz packages of quinoa due to possible contamination with pesticide. Consumers should check their pantries for the specific best-by dates listed.

    Product
    Quinoa, 16 oz plastic package
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1062-2019·2019-04-03

    Keystone Dental Recalls Paltop Surgical Kits Due to Oversized Hex Driver

    Keystone Dental Inc. is recalling Paltop Fully Guided Surgical Kits because the included 1.25mm Hex Driver may be oversized, making it difficult to engage screws and abutments.

    Product
    Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1064-2019·2019-04-03

    Ecolab Recalls Express Gel Hand Sanitizer Due to Chemical Contamination

    Ecolab is recalling 105 bottles of Express Gel Hand Sanitizer due to low levels of substituted benzene compounds found after malodor complaints.

    Product
    Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1060-2019·2019-04-03

    Ecolab Gel Hand Sanitizer Recalled for Chemical Contamination

    Ecolab Inc. is recalling specific lots of Ecolab Gel Hand Sanitizer due to the presence of low levels of substituted benzene compounds.

    Product
    ECOLAB — ECOLAB (ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1063-2019·2019-04-03

    Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue

    Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the hex driving feature may be slightly oversized, making it difficult to engage screws and abutments.

    Product
    Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
    Category
    Medical Device
    Distribution
    4 states