Browse Drug Recalls
7 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 7 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 7 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 12, 2016 | VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class III | VIRTUS PHARMACEUTICALS OPCO II L |
| Dec 12, 2016 | Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing ... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class III | VIRTUS PHARMACEUTICALS OPCO II L |
| Dec 12, 2016 | Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Min... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class III | VIRTUS PHARMACEUTICALS OPCO II L |
| Dec 12, 2016 | Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Di... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class III | VIRTUS PHARMACEUTICALS OPCO II L |
| Sep 2, 2016 | Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx ... | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | Class I | VIRTUS PHARMACEUTICALS OPCO II L |
| Sep 2, 2016 | Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only,... | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | Class I | VIRTUS PHARMACEUTICALS OPCO II L |
| Sep 2, 2016 | Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottl... | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | Class I | VIRTUS PHARMACEUTICALS OPCO II L |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.