Alvogen, Inc
Alvogen, Inc appears in FDA public data with 21 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0259-2026, Class II) was initiated on December 31, 2025.
Summary
- Total Recalls
- 21 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0259-2026 | Class II | Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD | December 31, 2025 |
| D-0245-2025 | Class I | Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, R | January 31, 2025 |
| D-0353-2023 | Class II | Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc | February 6, 2023 |
| D-0649-2021 | Class II | Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, | February 26, 2021 |
| D-1722-2019 | Class II | Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by | July 24, 2019 |
| D-1723-2019 | Class II | Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceu | July 24, 2019 |
| D-1277-2019 | Class I | FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: | April 19, 2019 |
| D-0941-2017 | Class II | Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manu | June 16, 2017 |
| D-0939-2017 | Class II | Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manu | June 16, 2017 |
| D-0940-2017 | Class II | Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manu | June 16, 2017 |
| D-0632-2017 | Class III | Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for | March 7, 2017 |
| D-0634-2017 | Class III | Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for | March 7, 2017 |
| D-0628-2017 | Class III | Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for | March 7, 2017 |
| D-0630-2017 | Class III | Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc | March 7, 2017 |
| D-0629-2017 | Class III | Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured f | March 7, 2017 |
| D-0627-2017 | Class III | Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc | March 7, 2017 |
| D-0633-2017 | Class III | Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for | March 7, 2017 |
| D-0635-2017 | Class III | Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for | March 7, 2017 |
| D-0631-2017 | Class III | Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc | March 7, 2017 |
| D-1082-2015 | Class II | NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed | April 21, 2015 |