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.

5426–5450 of 21589

  • ModerateFDA (Devices)·Z-2370-2021·2021-09-08

    Palindrome Precision RT Chronic Catheter Kit recalled for labeling and instruction updates

    Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to add point-of-use labeling and improve Instructions for Use. No adverse events have been reported.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2365-2021·2021-09-08

    Palindrome RT Repair Kit Voluntary Withdrawal for Labeling Enhancement

    Covidien is conducting a voluntary withdrawal of Palindrome RT Repair Kit 15 FR TAL 23cm devices to implement improved point-of-use labeling and enhance the Instructions for Use.

    Product
    Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0787-2021·2021-09-08

    Clopidogrel Tablets Recalled for Foreign Matter Contamination

    Macleods Pharma USA is recalling Clopidogrel 75 mg tablets due to the presence of foreign matter in the product. The affected lot was distributed nationwide.

    Product
    CLOPIDOGREL — CLOPIDOGREL (CLOPIDOGREL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0777-2021·2021-09-08

    Naproxen Sodium Tablets Recall Due to Manufacturing Quality Deviations

    Granules USA, Inc. voluntarily recalled Naproxen Sodium Tablets USP 220 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects approximately 11.45 million tablets distributed in New York.

    Product
    Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2361-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Labeling Enhancement Withdrawal

    Covidien, LP is voluntarily withdrawing Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and Instructions for Use. No injuries or illnesses have been reported.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2360-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit withdrawn for labeling and instruction improvements

    Covidien is voluntarily withdrawing Palindrome RT Chronic Catheter Kit devices worldwide to implement point-of-use labeling and enhanced Instructions for Use.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0774-2021·2021-09-08

    Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination

    Teva Pharmaceuticals is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial counts in an ingredient batch. The product was distributed nationwide.

    Product
    Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2408-2021·2021-09-08

    FaStep COVID-19 Test Devices Recalled for Unauthorized Laboratory Distribution

    Versea Diagnostics recalled 563,290 FaStep COVID-19 antibody test devices that were distributed to laboratories not certified under federal standards. The devices were authorized only for use in CLIA-certified laboratories.

    Product
    FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2407-2021·2021-09-08

    COVID-19 diagnostic test distributed outside certified laboratory channels

    CareStart COVID-19 Antigen Rapid Diagnostic Test units were distributed to non-CLIA-certified customers, violating the product's Emergency Use Authorization requirements.

    Product
    CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by thei
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2393-2021·2021-09-08

    Steripath Luer Transport Pack Gen2 Recalled for Incorrect Instructions

    Magnolia Medical Technologies is recalling 9,400 units of Steripath Luer Transport Pack Gen2 because they were shipped with incorrect Transfer Adapter Instructions For Use (IFU).

    Product
    Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0775-2021·2021-09-08

    Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination

    Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial test results in an excipient batch. The affected product was distributed nationwide.

    Product
    Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0955-2021·2021-09-08

    Raw Shelled Peanuts Recalled for Metal Contamination

    OLAM Edible Nuts is recalling raw shelled peanuts due to the presence of metal objects in the product. The recall affects two lots distributed to Georgia and Illinois.

    Product
    Raw Shelled Peanuts, Skins Removed, Split Nut Blanched Runner Peanuts, Net. Wt. 2000# Olam Edible Nuts - Blakely, GA
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2373-2021·2021-09-08

    Palindrome Precision RT Chronic Catheter Kit Withdrawn for Labeling Enhancements

    Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to implement point-of-use labeling and enhanced instructions for use. No illnesses or injuries have been reported.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0928-2021·2021-09-08

    Flourless Chocolate Torte mislabeled with wrong product and allergen information

    Gem City Fine Foods is recalling Flourless Chocolate Torte because the product is mislabeled with Triple Berry Streusel Cheesecake ingredients and nutrition information, and both products are labeled to contain pecans despite no nuts being used.

    Product
    Flourless Chocolate Torte, 14 oz., in recyclable plastic circular container with black base and clear lid, Gem City Fine Foods, 3403 S 1400 W, Suite C, West Valley City, UT 84119. There are 4/cs. UPC 855026001186. Store Frozen or Thawed in Fridge.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2339-2021·2021-09-01

    OASIS MRI table pads recalled for missing latex allergen labeling

    Hitachi Healthcare Americas has recalled OASIS MRI System table pads due to missing labels and user manual notification about dry natural rubber content. The missing notification violates federal labeling requirements for this latex allergen.

    Product
    OASIS MRI System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2334-2021·2021-09-01

    FDA Recalls Reprocessed IVUS Catheters Due to Reprocessing Cycle Violation

    Northeast Scientific Inc. is recalling 690 reprocessed intravascular ultrasound catheters because they exceed the FDA-approved single reprocessing cycle limit. Devices were distributed nationwide across ten states.

    Product
    NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0766-2021·2021-09-01

    Sodium Phenylbutyrate Powder Recalled for Failed Impurities Specifications

    SigmaPharm Laboratories is recalling Sodium Phenylbutyrate powder nationwide due to out-of-specification impurity results found during routine testing. Affected bottles have specific lot numbers and expiration dates ranging from May 2023 to May 2024.

    Product
    Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0769-2021·2021-09-01

    Erythromycin Topical Solution Recalled for Defective Container Seal

    Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL bottles) due to defective containers that may lack seal integrity, potentially allowing contamination or leakage.

    Product
    Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2333-2021·2021-09-01

    BD Mouse IgG2a Antibody Reagent Recalled for Manufacturing Contamination

    This antibody reagent was recalled due to manufacturing contamination that may produce false positive staining results in laboratory tests. The affected lot was distributed worldwide.

    Product
    BD" Mouse IgG2a Isotype Control APC X39 ASR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0763-2021·2021-09-01

    PDI Povidone-Iodide Cleansing Scrub Swabstick Recall for Subpotency

    Professional Disposables International is recalling PDI Povidone-Iodide Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning the active ingredient strength is below the required specification.

    Product
    PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0764-2021·2021-09-01

    PDI Duo-Swab Povidone-Iodine Cleansing Swabstick Recalled for Subpotency

    Professional Disposables International is recalling PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks due to subpotency—the active ingredient is below the specified strength, which may reduce effectiveness for skin antisepsis.

    Product
    PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0757-2021·2021-09-01

    Micafungin for Injection recalled for incomplete package insert

    Xellia Pharmaceuticals is recalling Micafungin for Injection due to an incomplete package insert that omits required sections on adverse reactions, drug interactions, and use in specific populations.

    Product
    Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0758-2021·2021-09-01

    PVP Iodine Prep Pads Recalled for Subpotent Active Ingredient

    Professional Disposables International is recalling PVP Iodine Prep Pads nationwide because the products are subpotent—containing less active ingredient than specified. The affected prep pads may not provide adequate antiseptic protection.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0761-2021·2021-09-01

    PDI Povidone-Iodine Swabstick Prep Pads Recalled for Subpotency

    Professional Disposables International is recalling PDI Povidone-Iodine Swabsticks nationwide because the product is subpotent—meaning the active ingredient is below the required specification.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0759-2021·2021-09-01

    PDI Povidone-Iodine Prep Pads Recalled for Subpotent Active Ingredient

    Professional Disposables International is recalling PDI Povidone-Iodine Prep Pads distributed nationwide because the product is subpotent—the active ingredient falls below specification. Consumers should stop using affected lots and consult their healthcare provider.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide