Alvogen, Inc FDA Recalls

4 recalls on file across drugs, 1 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, Class IIDec 31, 2025Product Mix-Up: A single bottle of this lot was reported by	Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 15	Class IIDrugs	Dec 31, 2025
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed Class IJan 31, 2025Defective delivery system - patches could be multi-stacked,	Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single produ	Class IDrugs	Jan 31, 2025
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 5Class IIFeb 6, 2023Sub-Potent Drug: Out of specification for assay at the 24 mo	Sub-Potent Drug: Out of specification for assay at the 24 month interval.	Class IIDrugs	Feb 6, 2023
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: AlvoClass IIFeb 26, 2021Subpotent drug: Out of specification for assay of naloxone a	Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)	Class IIDrugs	Feb 26, 2021