Alvogen, Inc

FDA Regulatory Profile

Summary

Total Recalls
21 (2 Class I)
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0259-2026Class IILevothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYDDecember 31, 2025
D-0245-2025Class IFentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, RJanuary 31, 2025
D-0353-2023Class IILevothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd IncFebruary 6, 2023
D-0649-2021Class IIBuprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, February 26, 2021
D-1723-2019Class IIMacrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich PharmaceuJuly 24, 2019
D-1722-2019Class IINitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed byJuly 24, 2019
D-1277-2019Class IFENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: April 19, 2019
D-0940-2017Class IIClindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, ManuJune 16, 2017
D-0941-2017Class IIClindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, ManuJune 16, 2017
D-0939-2017Class IIClindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, ManuJune 16, 2017
D-0628-2017Class IIIAdalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured forMarch 7, 2017
D-0635-2017Class IIIAdalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured forMarch 7, 2017
D-0634-2017Class IIIAdalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured forMarch 7, 2017
D-0630-2017Class IIINifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen IncMarch 7, 2017
D-0629-2017Class IIIAdalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured fMarch 7, 2017
D-0633-2017Class IIIAdalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured forMarch 7, 2017
D-0627-2017Class IIINifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen IncMarch 7, 2017
D-0631-2017Class IIINifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen IncMarch 7, 2017
D-0632-2017Class IIIAdalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured forMarch 7, 2017
D-1082-2015Class IINITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- DistributedApril 21, 2015