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.

5601–5625 of 21589

  • ModerateFDA (Drugs)·D-0493-2021·2021-06-02

    Cardinal Health Recalls Leucovorin Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling Leucovorin 15mg tablets due to intermittent temperature excursions during storage. The affected products were distributed in Florida, Georgia, and South Carolina.

    Product
    LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0466-2021·2021-06-02

    Cardinal Health Recalls Prilosec Due to Temperature Excursions

    Cardinal Health is recalling Prilosec (Omeprazole Magnesium) oral suspension packets due to intermittent temperature excursions during storage.

    Product
    PRILOSEC — PRILOSEC (OMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0470-2021·2021-06-02

    Cardinal Health Recalls Phenobarbital Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling Phenobarbital Tablets, USP 32.4 mg due to intermittent exposure to temperature excursions during storage.

    Product
    Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0467-2021·2021-06-02

    Cardinal Health Recalls Iron 100 Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling Iron 100 with Vitamin C Tablets due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0587-2021·2021-06-02

    Cardinal Health Recalls Restora Omega-3 Supplement Due to Temperature Excursions

    Cardinal Health Inc. is recalling 31 cartons of Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules due to intermittent exposure to temperature excursions during storage.

    Product
    Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1675-2021·2021-06-02

    Roche Recalls Iron Gen 2 Reagent Cassettes Due to Discrepant Results

    Roche Diagnostics is recalling 20,468 Iron Gen 2 reagent cassettes because they may produce discrepant elevated results on specific analyzers.

    Product
    IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0475-2021·2021-06-02

    Cardinal Health Recalls Prenatal Tablets Due to Temperature Excursions

    Cardinal Health is recalling 41 bottles of prenatal tablets due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1681-2021·2021-06-02

    Nobel Biocare Procera LLC Recalls Implant Crowns Not Manufactured to Specification

    Nobel Biocare Procera LLC is recalling specific implant crowns because they were not manufactured to specification. The recall affects units distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0442-2021·2021-06-02

    Cardinal Health Recalls Nuedexta Due to Temperature Excursions

    Cardinal Health is recalling 255 bottles of Nuedexta capsules due to intermittent exposure to temperature excursions during storage.

    Product
    NUEDEXTA — NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0480-2021·2021-06-02

    Cardinal Health Recalls Arnuity Ellipta Due to Temperature Excursions

    Cardinal Health is recalling 353 Arnuity Ellipta inhalers distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.

    Product
    ARNUITY ELLIPTA — ARNUITY ELLIPTA (FLUTICASONE FUROATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0460-2021·2021-06-02

    Cardinal Health Recalls Pravachol 40mg Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling Pravachol 40mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0522-2021·2021-06-02

    Cardinal Health Recalls Belsomra Tablets Due to Temperature Excursions

    Cardinal Health is recalling 119 cartons of Belsomra (suvorexant) 10 mg tablets due to intermittent temperature excursions during storage.

    Product
    Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets Rx only NDC 00006-0033-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0539-2021·2021-06-02

    Cardinal Health Recalls Zolpidem Tablets Due to Temperature Excursions

    Cardinal Health is recalling 55 boxes of Zolpidem Tartrate Sublingual Tablets 3.5 mg due to intermittent exposure to temperature excursions during storage.

    Product
    ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0421-2021·2021-06-02

    Cardinal Health Recalls Nitrofurantoin Capsules Due to Storage Temperature Excursions

    Cardinal Health Inc. is recalling 15 bottles of Nitrofurantoin Macrocrystals Capsules 25 mg due to intermittent exposure to temperature excursions during storage.

    Product
    Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1686-2021·2021-06-02

    CooperSurgical Recalls Incorrectly Packaged Ultem Koh Cup Vaginal Delineators

    CooperSurgical is recalling specific Koh Cup vaginal delineators that were incorrectly packaged with a 3.5cm cup instead of the required 3.0cm model.

    Product
    The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
    Category
    Medical Device
    Distribution
    3 states