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.

3326–3350 of 3531

  • ModerateFDA (Drugs)·D-0814-2021·2021-09-29

    Promethazine Syrup Plain Recall Due to Microbial Contamination

    Morton Grove Pharmaceuticals is recalling Promethazine Syrup Plain 6.25 mg/5 mL in 1-pint bottles due to potential microbial contamination in liquid sugar batches used during manufacturing.

    Product
    Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16
    Category
    Drug
    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 (Drugs)·D-0807-2021·2021-09-29

    Carbamazepine 200mg Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling Carbamazepine 200mg tablets (Lot R01562, expiring 10/2022) distributed in North Carolina because they failed to meet required dissolution specifications, which may affect the drug's effectiveness.

    Product
    CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
    Category
    Drug
    Distribution
    1 state
  • 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 (Food)·F-1002-2021·2021-09-29

    Alfalfa Sprouts Recall Due to Improper Temperature Storage

    Sysco Atlanta is recalling Sunny Creek and Bloomsbury Organic Farm alfalfa sprouts sold in Georgia, North Carolina, and Tennessee because the product was not held at appropriate temperatures and may be unsafe to consume.

    Product
    Alfalfa Sprouts 12/4oz Plastic container, sold under the the brand names of: Sunny Creek UPC 7 38015 77740 1 SUNNY CREEK FARM Tryon, NC 28782 and BLOOMSBURY ORGANIC FARMKEEP 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 (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-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
  • 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-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 (Devices)·Z-2495-2021·2021-09-29

    Ad-Tech TECH ATTACH Cable Recalled for Incorrect Label Information

    Ad-Tech Medical recalled its Lightweight TECH ATTACH Cable due to incorrect labels on affected units. The cables are designed to connect electrodes to third-party monitors and stimulators.

    Product
    Ad-Tech Lightweight 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 (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-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-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 (Food)·F-0993-2021·2021-09-29

    Fleischmann's Compressed Fresh Yeast Recall Due to Temperature Control

    Sysco Atlanta is recalling Fleischmann's Yeast Compressed Fresh in 24/1 lb packages because the product was not stored at appropriate temperatures, creating potential food safety risk.

    Product
    FLEISCHMANN'S YEAST COMPRESSED FRESH ESL 24/1lbs Paper/Foil overwrap
    Category
    Food
    Distribution
    3 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-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-0799-2021·2021-09-22

    Kroger 70% Isopropyl Alcohol Bottles Mislabeled; Contains Hydrogen Peroxide

    Vi-Jon, Inc. is recalling Kroger 70% Isopropyl Rubbing Alcohol due to a labeling mix-up. The bottles are labeled as isopropyl alcohol but contain Hydrogen Peroxide 3% instead.

    Product
    70% ISOPROPYL RUBBING ALCOHOL — 70% ISOPROPYL RUBBING ALCOHOL (ISOPROPYL RUBBING ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2481-2021·2021-09-22

    Leica BOND Primary Antibody CDX2 Recalled for Performance Specification Issue

    Leica Microsystems recalls BOND Ready-To-Use Primary Antibody CDX2 (PA0375, Lot 69909) because the product may not perform as specified in its instructions for use. The recall affects 237 units distributed nationwide.

    Product
    BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0802-2021·2021-09-22

    Betamethasone Dipropionate Lotion recalled for unknown impurity

    Akorn, Inc. is recalling Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, due to an unknown impurity found in the product that exceeds specification limits. The affected lots were distributed nationwide.

    Product
    Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0801-2021·2021-09-22

    Glycopyrrolate Injection Recalled for Failed Impurities and Degradation Specifications

    Meitheal Pharmaceuticals is recalling Glycopyrrolate Injection, USP 4mg per 20mL in 20mL multi-dose vials due to failed impurities and degradation specifications. The recall affects specific lots distributed nationwide in the USA and India.

    Product
    Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2437-2021·2021-09-15

    Solero MTA Generator Requires Software Upgrade to Reduce Startup Error

    Angiodynamics is servicing specific Solero MTA Generator units to upgrade the software and reduce Error 0001 during startup. Affected units are identified by serial number.

    Product
    Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0791-2021·2021-09-15

    Hand Sanitizer 80% Alcohol Recall Due to Acetaldehyde Contamination

    Charles Paint Research Inc is recalling hand sanitizer products manufactured with acetaldehyde and acetal impurities exceeding allowable limits due to facility contamination issues.

    Product
    HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2415-2021·2021-09-15

    MRI System Tabletop May Fail to Move, Delaying Patient Evacuation

    Philips MRI systems (Model 781260) may have a tabletop malfunction in manual mode that prevents complete movement, potentially delaying patient evacuation and treatment.

    Product
    SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremitie
    Category
    Medical Device
    Distribution
    Distributed nationwide