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.

5401–5425 of 21589

  • 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 (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-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 (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 (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 (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 (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
  • ModerateFDA (Devices)·Z-2439-2021·2021-09-15

    Solero Generator PG requires software service for startup error

    Angiodynamics is recalling 65 Solero Generator PG devices due to software Error 0001 that can occur during system startup. A software upgrade is required to reduce the incidence of this error.

    Product
    Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2438-2021·2021-09-15

    Solero MTA Generator refurbished units require software servicing

    Eight refurbished Solero MTA Generator units require software upgrades to reduce startup errors occurring in specific serial numbers.

    Product
    Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0792-2021·2021-09-15

    Hand Sanitizer Recalled for Acetaldehyde and Acetal Above Limits

    Charles Paint Research Inc is recalling 600 gallons of 80% alcohol hand sanitizer distributed in Michigan because the product contains acetaldehyde and acetal above allowable limits.

    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
    1 state
  • ModerateFDA (Drugs)·D-0793-2021·2021-09-15

    QiYu Hand Sanitizer 75% Ethyl Alcohol Recalled for Subpotency

    Native Promotional Products is recalling QiYu Hand Sanitizer 500 mL bottles due to subpotency—the ethyl alcohol content does not meet the labeled 75% (v/v) specification. The voluntary recall affects products distributed to tribal nations in 13 states.

    Product
    QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by Native Promotional Products, Tulsa, OK NDC 74447-010
    Category
    Drug
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2436-2021·2021-09-15

    Solero MTA Generator requires software upgrade for startup error

    Angiodynamics is recalling specific refurbished Solero MTA Generators due to Error 0001, which occurs during system startup. A software upgrade is required to reduce the error's frequency.

    Product
    Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
    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
    1 state
  • ModerateCPSC·21194·2021-09-09

    Janod Children's Shaving Kits Recalled for Excessive Phthalate Levels

    Juratoys is recalling about 13,600 Janod Children's Shaving Kits because the brown trim on the bags contains banned phthalates in excess of federal limits. Consumers should stop using the kit and return it for a full refund.

    Product
    Janod Children's Shaving Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·21779·2021-09-09

    Burley Ballz QR Skewers Recalled Due to Fall Hazard

    Burley Design is recalling Ballz QR Skewers, which attach cargo trailers to bicycles, because the skewer can shear or bend, potentially destabilizing the trailer and bicycle and causing the rider to fall.

    Product
    Ballz QR Skewers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2369-2021·2021-09-08

    Palindrome RT Repair Kit Withdrawn for Labeling and Instruction Enhancements

    Covidien is voluntarily withdrawing the Palindrome RT Repair Kit (Lot 1925300162) worldwide to implement improved point-of-use labeling and enhanced Instructions for Use (IFU).

    Product
    Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2371-2021·2021-09-08

    Palindrome Precision RT Catheter Kit Withdrawn for Labeling and Instruction Enhancements

    Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to implement point-of-use labeling and enhanced instructions for use on all affected units.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2362-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement

    Covidien is voluntarily withdrawing specific lots of Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and enhancements to device instructions for use.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2366-2021·2021-09-08

    Palindrome RT Repair Kit Withdrawn for Enhanced Labeling and Instructions

    Covidien is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 28cm to improve point-of-use labeling and Instructions for Use. No illnesses or injuries have been reported.

    Product
    Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2367-2021·2021-09-08

    Palindrome RT Repair Kit voluntary withdrawal for labeling enhancements

    Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit to implement improved point-of-use labeling and enhance the Instructions for Use. This affects Item Code 8888541133 (Lot Number 1705400292) distributed worldwide.

    Product
    Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2359-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Withdrawn for Labeling and Instructions Enhancement

    Covidien voluntarily withdrew Palindrome RT Chronic Catheter Kit worldwide to implement improved point-of-use labeling and enhanced instructions for use on each device.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2358-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement

    Covidien is voluntarily withdrawing the Palindrome RT Chronic Catheter Kit to add point-of-use labeling and enhance instructions for use. The withdrawal affects specific lot numbers distributed worldwide.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2372-2021·2021-09-08

    Palindrome Precision RT Chronic Catheter Kits Withdrawn for Labeling and Instruction Updates

    Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance device instructions for proper use.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
    Category
    Medical Device
    Distribution
    0 states