Morristown, NJ, United States
Alvogen, Inc recalls
6 recalls recorded since 2018, most recently on 31 December 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)2
Terminated or completed4
Class I (FDA)2
Ongoing Class II Drugs
- Recall started
- 31 December 2025
- Reason
- Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0259-2026
- Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.
Ongoing Class I Drugs
- Recall started
- 31 January 2025
- Reason
- Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0245-2025
- Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA
Terminated Class II Drugs
- Recall started
- 6 February 2023
- Terminated
- 18 March 2024
- Reason
- Sub-Potent Drug: Out of specification for assay at the 24 month interval.
- Distribution
- Nationwide and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0353-2023
- Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.
Terminated Class II Drugs
- Recall started
- 26 February 2021
- Terminated
- 16 February 2022
- Reason
- Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0649-2021
- Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03
Terminated Class II Drugs
- Recall started
- 24 July 2019
- Terminated
- 4 August 2021
- Reason
- Failed dissolution specifications
- Distribution
- Natonwide, PR
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1723-2019, D-1722-2019
- Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01
- Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01
Terminated Class I Drugs
- Recall started
- 19 April 2019
- Terminated
- 14 August 2019
- Reason
- Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1277-2019
- FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.