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.

5376–5400 of 21589

  • ModerateFDA (Devices)·Z-2496-2021·2021-09-29

    Ad-Tech TECH ATTACH Cable Recalled Due to Incorrect Labeling

    Ad-Tech Medical Instrument Corporation is recalling TECH ATTACH Cables due to incorrect labeling. The cables connect electrodes to third-party monitors and stimulators.

    Product
    Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0808-2021·2021-09-29

    Chantix Varenicline Tablets Recalled for Nitroso Impurity

    Pfizer is recalling Chantix (varenicline) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit, a manufacturing deviation.

    Product
    Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2487-2021·2021-09-29

    SARS-CoV-2 Process Control Swab Recalled Due to Plasmid DNA Contamination

    Microbiologics Inc is recalling its SARS-CoV-2 Process Control (Swab) because certain lot numbers were contaminated with plasmid DNA containing SARS-CoV-2 sequences. The affected product was distributed in the United States and internationally.

    Product
    SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0810-2021·2021-09-29

    Chantix Varenicline Tablets Recalled for N-Nitroso Impurity

    Pfizer is recalling specific lots of Chantix (varenicline) 1 mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The affected lots were distributed nationwide.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0999-2021·2021-09-29

    Phillips Majestic Blue Crab Meat Recall Due to Temperature Control

    Sysco Atlanta is recalling Phillips Majestic Blue pasteurized crab meat because the product was not held at appropriate temperatures and may be unsafe to consume.

    Product
    Phillips Majestic Blue Colossal Clawfingers 20/40 6/12 oz CANS UPC 10070057145068 & Phillips Majestic Blue Large Clawfingers 50/70 6/12oz CANS UPC 10070057145167 PASTEURIZED PREMIUM CRAB MEAT WILD CAUGHT KEEP REFRIGERATED
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0997-2021·2021-09-29

    Sysco Atlanta Diced Roma Tomatoes Recalled for Improper Temperature Storage

    Sysco Atlanta is recalling Imperial Fresh diced Roma tomatoes due to improper temperature storage that may have made the product unsafe to consume.

    Product
    IMPERIAL FRESH TOMATO ROMA DICED 3/8 TRAY 1/5lbs Plastic overwrap tray
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0994-2021·2021-09-29

    Gordo's Mexican Cheese Dip Recalled for Temperature Storage Risk

    Sysco Atlanta recalled Gordo's Authentic Mexican Restaurant Style Cheese Dip because the product was not held at the appropriate temperature, making it potentially unsafe to consume.

    Product
    GORDO'S AUTHENTIC MEXICAN RESTAURANT STYLE CHEESE DIP NET WT. 5LBS METRIC WT. 1.81 kgs (4/5lbs Plastic tub) KACHWA ENTERPRISES LAKE CITY, GEORGIA 30260 MANUFACTURED BY PLANT NO. 13-370
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0998-2021·2021-09-29

    Ken's Steakhouse Asian Sesame Dressing Recalled for Temperature Control

    Sysco Atlanta is recalling Ken's Steakhouse Asian Sesame Dressing after the product was not held at appropriate temperatures. The improper storage conditions could make the food unsafe to consume.

    Product
    KEN'S STEAKHOUSE DRESSING ASIAN SESAME DRESSING 4/1gallon Plastic container Ken's Foods Inc Marlborough, MA 01752 MUST BE REFRIGERATED
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0824-2021·2021-09-29

    Chlorzoxazone 750 mg Tablets Recalled Due to CGMP Deviations

    Glenmark Pharmaceuticals is recalling Chlorzoxazone 750 mg tablets nationwide due to current good manufacturing practice (CGMP) deviations. The voluntary recall affects 4,752 bottles with five affected lot numbers.

    Product
    Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0809-2021·2021-09-29

    Pfizer recalls Chantix tablets for N-nitroso-varenicline impurity

    Pfizer is recalling certain lots of Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0817-2021·2021-09-29

    Sodium Sulfacetamide Wash Recalled for Subpotency Issues

    Monarch PCM, LLC is recalling Sodium Sulfacetamide 10% Wash due to subpotency, meaning some bottles contain insufficient active ingredient or preservative levels.

    Product
    Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0821-2021·2021-09-29

    Glenmark Naproxen Sodium Tablets recalled for CGMP deviations

    Glenmark Pharmaceuticals is recalling 9,552 bottles of Naproxen Sodium Tablets USP 275 mg nationwide due to CGMP (current Good Manufacturing Practice) deviations identified at the manufacturing facility.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0825-2021·2021-09-29

    Zonisamide Capsules Recalled for Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Zonisamide Capsules 50 mg nationwide due to manufacturing deviations. The recall affects approximately 15,936 bottles across multiple lots with expiration dates in May 2022.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0826-2021·2021-09-29

    Zonisamide Capsules Recalled by Glenmark Due to CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Zonisamide Capsules USP 100 mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects multiple lot numbers distributed from August 2021.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0813-2021·2021-09-29

    Sirolimus Tablets Recalled for Failed Impurities and Degradation Specifications

    American Health Packaging is recalling Sirolimus 1 mg tablets (Lot #1000789, expiring 10/31/2022) distributed nationwide because they failed impurities and degradation specifications.

    Product
    SIROLIMUS — SIROLIMUS (SIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0829-2021·2021-09-29

    Zonisamide 100 mg Capsules Recalled Due to Quality Control Gaps

    Direct Rx is recalling Zonisamide 100 mg Capsules (30-count bottles, Lot #17JU2118, expiration 5/31/23) distributed in Florida due to gaps in the quality system in the Quality Control microbiology laboratory.

    Product
    Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0811-2021·2021-09-29

    Chantix (Varenicline) Tablets Recalled for Impurity Above FDA Limits

    Pfizer is recalling Chantix (varenicline) 1 mg tablets distributed nationwide due to the presence of N-nitroso-varenicline impurity above the FDA's acceptable interim intake limit. Affected lots have expiration dates from September 2021 to December 2023.

    Product
    Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0806-2021·2021-09-29

    Entacapone Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling Entacapone 200 mg tablets distributed in Colorado, Florida, Missouri, and Ohio due to failed dissolution specifications that may affect drug efficacy.

    Product
    ENTACAPONE — ENTACAPONE (ENTACAPONE)
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2486-2021·2021-09-29

    Microbiologics SARS-CoV-2 Process Control Pellets Recalled for Product Specification Issue

    Microbiologics Inc is recalling 218 units of SARS-CoV-2 process control pellets (catalog HE0062S) used to validate diagnostic tests. The FDA Class II recall involves product composition regarding RNA transcript content.

    Product
    SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1003-2021·2021-09-29

    TULKOFF Ginger Puree Recalled for Improper Temperature Storage

    Sysco Atlanta is recalling TULKOFF Ginger Puree because the product was not held at appropriate temperatures, making it potentially unsafe to consume.

    Product
    TULKOFF Ginger Puree 6/32oz Tubs UPC 1 00 70607 50015 6 Tulkoff Food Products, Inc. Baltimore, MD 21224 KEEP REFRIGERATED
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0995-2021·2021-09-29

    I Siciliani Primosale Pepato Sheep's Milk Cheese Recall

    Sysco Atlanta, LLC is recalling I Siciliani Primosale Pepato sheep's milk cheese because it was not held at appropriate temperatures, potentially making it unsafe to consume.

    Product
    I SICILIANI PRIMOSALE PEPATO sheep's milk cheese with black pepper 2/5lbs Plastic overwrap PRODUCT OF ITALY
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0823-2021·2021-09-29

    Drug Recall: Chlorzoxazone Tablets Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling 1,800 bottles of Chlorzoxazone Tablets USP 375 mg nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated on August 27, 2021.

    Product
    Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1001-2021·2021-09-29

    Sunny Creek Sprout Bean Fresh recalled for improper temperature storage

    Sysco Atlanta is recalling Sunny Creek Sprout Bean Fresh in 1/5 lb plastic bags due to improper temperature storage that could make the food unsafe to consume.

    Product
    SUNNY CREEK SPROUT BEAN FRESH 1/5lbs Plastic bag
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1000-2021·2021-09-29

    Minor's Seafood Base recalled for improper temperature storage

    Sysco Atlanta is recalling Minor's Seafood Base No MSG GF shipped between July and August 2021 to Georgia, North Carolina, and Tennessee because the product was not held at an appropriate temperature and may be unsafe to consume.

    Product
    MINOR'S SEAFOOD BASE NO MSG GF 6/16 OZ (1 lb) 453 G UNITS Plastic container (pint) gluten free DISTRIBUTED BY NESTLE PROFESSIONAL NORTH AMERIC, SOLON, OH 44139
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0992-2021·2021-09-29

    Daiya Vegan Cheddar Style Cheese Slices Recalled for Temperature Control

    Sysco Atlanta is recalling Daiya vegan cheddar cheese slices because the product was not held at an appropriate temperature. Affected lots shipped to GA, NC, and TN between July and August 2021 may be unsafe to consume.

    Product
    DAIYA CHEESE VEGAN CHEDDAR STYLE SLICE 8/7.8oz Plastic bag MANUFACDTURED BY: DAIYA FOODS INC., BURNABY, BC CANADA VSA 4R4 PRODUCT OF CANADA KEEP REFRIGERATED UPC 3 08 71459 00022 1
    Category
    Food
    Distribution
    3 states