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.

5626–5650 of 21589

  • ModerateFDA (Drugs)·D-0530-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 47 bottles of NAT B VIT D3 2000U tablets due to intermittent exposure to temperature excursions during storage.

    Product
    NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0432-2021·2021-06-02

    Cardinal Health Recalls Gemcitabine Injection Due to Temperature Excursions

    Cardinal Health is recalling Gemcitabine Injection 200mg/5.26ml vials due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1678-2021·2021-06-02

    Nobel Biocare Procera Implant Crown Recall for Manufacturing Defects

    Nobel Biocare Procera LLC is recalling seven implant crown units because they were not manufactured to specification. The recall covers distribution in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - 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: 77352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0552-2021·2021-06-02

    Cardinal Health Recalls LYRICA Capsules Due to Temperature Excursions

    Cardinal Health is recalling 49 bottles of LYRICA (pregabalin) 200mg capsules due to intermittent exposure to temperature excursions during storage.

    Product
    LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORE
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0596-2021·2021-06-02

    Cardinal Health Recalls Cough Syrup Due to Temperature Excursions

    Cardinal Health Inc. is recalling 15 bottles of a cough syrup due to intermittent temperature excursions during storage.

    Product
    Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not for Household Use Rx Only NDC 60432-275-16 Distributed By: Wockhardt USA, LLC Parsippany, NJ 07054
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·F-0563-2021·2021-06-02

    Brew Dr. Uplift Blueberry Raspberry Yerba Mate Recalled for Yeast

    Brew Dr. Uplift Blueberry Raspberry Yerba Mate is being recalled because yeast was found in the shelf-stable cans.

    Product
    Brew Dr. Uplift Blueberry Raspberry Yerba Mate Guayusa, Green Tea, Natural Caffeine With Probiotics. 12/16 oz. aluminum cans per cardboard flat. UPC 8 57161 00867 9. The label is read in parts: "***BLUEBERRY RASPBERRY ***YERBA MATE * GUAYUSA * GREEN TEA***BREW DR UPLIFT *** N
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0445-2021·2021-06-02

    Cardinal Health Recalls MURO-128 Eye Drops Due to Temperature Excursions

    Cardinal Health is recalling MURO-128 2% eye drops due to intermittent temperature excursions during storage. The affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0500-2021·2021-06-02

    Cardinal Health Recalls Livalo Tablets Due to Temperature Excursions

    Cardinal Health is recalling 453 bottles of Livalo (pitavastatin calcium) 2 mg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    LIVALO — LIVALO (PITAVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1688-2021·2021-06-02

    Ortho VITROS CoV2 Ag Calibrator Recalled for Calibration Failures

    Ortho-Clinical Diagnostics is recalling 74 units of VITROS CoV2 Ag calibrator (Lot 0020) due to potential unexpected calibration failures.

    Product
    VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0563-2021·2021-06-02

    Cardinal Health Recalls Medroxyprogesterone Acetate Injectable Due to Temperature Excursions

    Cardinal Health Inc. is recalling 148 syringes of medroxyprogesterone acetate injectable suspension due to intermittent exposure to temperature excursions during storage.

    Product
    medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0424-2021·2021-06-02

    Cardinal Health Recalls Erythromycin Tablets Due to Temperature Excursions

    Cardinal Health is recalling Erythromycin Tablets 250mg due to intermittent temperature excursions during storage. The recall affects 135 cartons distributed in Florida, Georgia, and South Carolina.

    Product
    ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0496-2021·2021-06-02

    Cardinal Health Recalls Enbrace HR Prenatal Vitamins Due to Temperature Excursions

    Cardinal Health is recalling 11 bottles of Enbrace HR prenatal vitamins due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    ENBRACE HR — ENBRACE HR (LEVOMEFOLATE MAGNESIUM, LEUCOVORIN, FOLIC ACID, FERROUS CYSTEINE GLYCINATE, MAGNESIUM ASCORBATE, ZINC ASCORBATE, COCARBOXYLASE, FLAVIN ADENINE DINUCLEOTIDE, NADH, PYRIDOXAL PHOSPHATE ANHYDROUS, COBAMAMIDE, BETAINE, MAGNESIUM L-THREONATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, AND PHOSPHATIDYL SERINE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0409-2021·2021-06-02

    Cardinal Health Recalls Lidocaine HCL Visc 2% Due to Temperature Excursions

    Cardinal Health Inc. is recalling 240 bottles of Lidocaine HCL Visc 2% 100ml due to intermittent temperature excursions during storage.

    Product
    LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0519-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

    Cardinal Health is recalling Vitamin D3 50mcg tablets due to intermittent exposure to temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0598-2021·2021-06-02

    Native Fluoride Toothpaste Recalled for Incorrect Fluoride-Free Labeling

    Accupac, Inc. is recalling Native Fluoride Toothpaste for Sensitive Teeth because the primary label may incorrectly state 'Fluoride-Free' instead of 'With Fluoride.'

    Product
    Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111 NDC: 69423-903-41, UPC 0 37000 28803 9
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0458-2021·2021-06-02

    Cardinal Health Recalls Synjardy Tablets Due to Temperature Excursions

    Cardinal Health is recalling 269 bottles of Synjardy XR tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    SYNJARDY — SYNJARDY (EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0585-2021·2021-06-02

    Cardinal Health Recalls Folivane-Plus Capsules Due to Temperature Excursions

    Cardinal Health is recalling 80 bottles of Folivane-Plus capsules because they were intermittently exposed to temperature excursions during storage.

    Product
    Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules Rx Only NDC 13811-539-90 Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872
    Category
    Drug
    Distribution
    3 states