Virtus Pharmaceuticals Recalls Virt-Nate and Virt Gard Tablets for Labeling Error
Virtus Pharmaceuticals is recalling Virt-Nate and Virt Gard Tablets because the labels do not reflect the correct amount of Dietary Folate Equivalents.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a remote possibility of adverse health consequences. The hazard is a labeling error regarding Dietary Folate Equivalents, which fits the criteria for minor labeling errors.
Plain-English summary
Virtus Pharmaceuticals, LLC has initiated a recall of Virt-Nate Tablets and Virt Gard Tablets. The recall was initiated because the product labels do not reflect the correct amount of Dietary Folate Equivalents (DFEs) calculated based on the product formulation.
The recall involves 2,209 bottles of Virt-Nate Tablets. The affected products were distributed in Arizona, Colorado, Illinois, Indiana, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Vermont, and Wisconsin. The recall also covers Virt Gard Tablets distributed in Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, and West Virginia.
The affected lots include Lot# M185860 with an expiration date of 12/2018 and Lot# M1903000 with an expiration date of 4/2019. Consumers should check their medication for these specific lot numbers and expiration dates. The source text does not specify further consumer actions or report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
- Manufacturer
- VIRTUS PHARMACEUTICALS LLC.
- Category
- Drug — Tablets
- Hazard
- Affected units
- 2,209
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot# M185860 Expiration Date: 12/2018 Lot# M1903000 Expiration Date: 4/2019
Distribution
Part of a larger recall action
This product is one of 2 recalled by VIRTUS PHARMACEUTICALS LLC. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · VIRTUS PHARMACEUTICALS LLC.
See all →- ModerateVirtus Pharmaceuticals Recalls Virt-Nate and Virt Gard Tablets for Labeling Error
FDA (Food) · 2018-09-12
- LowVirtus Pharmaceuticals Recalls Leaking Prenatal/Postnatal Capsules
FDA (Drugs) · 2016-06-29
- LowVirtus Recalls Hyoscyamine Sulfate Tablets Due to Broken Dessicants
FDA (Drugs) · 2016-06-29
- LowVirtus Pharmaceuticals Recalls Prenatal Supplement Due to Leaking Capsules
FDA (Drugs) · 2016-04-13
- LowVirt-Nate Prenatal Supplement Recalled for Incorrect Tablet Imprinting
FDA (Drugs) · 2016-03-23
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02