Alvogen recalls

Alvogen has 21 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 21 Jan 2026. 2 are still ongoing. 1 was reported in the last 12 months.

Total recalls21since 2014

Last 12 months1reported

Class I210% of total

Ongoing2latest 21 Jan 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 1Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 1 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 2 10%Class II 10 48%Class III 9 43%

Why alvogen is recalled

Product types

Brands

Fentanyl System210%
Nitrofurantoin Monohydrate/ Macrocrystalline210%
Buprenorphine And Naloxone15%
Macrobid15%

By year

202615%
202515%
202315%
202115%
2019314%
20171257%
201515%
201415%

Ongoing alvogen recalls

2 active

Reported	Class	Recall	Company	Reason	Where
21 Jan 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg recalled	Alvogen	Packaging Defects	Nationwide
26 Feb 2025Drug	CLASS I	Fentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl System	Alvogen	Packaging Defects	Nationwide

All alvogen recalls, newest first

21 total

Reported	Class	Recall	Company	Reason	Where
21 Jan 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg recalled	Alvogen	Packaging Defects	Nationwide
26 Feb 2025Drug	CLASS I	Fentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl System	Alvogen	Packaging Defects	Nationwide
8 Mar 2023Drug	CLASS II	Levothyroxine Sodium Tablets, USP 112 mcg recalled by Alvogen	Alvogen	Potency & Assay	Nationwide
14 Jul 2021Drug	CLASS II	Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg recalled by AlvogenBuprenorphine And Naloxone	Alvogen	Potency & Assay	Nationwide
21 Aug 2019Drug	CLASS II	Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg recalledNitrofurantoin Monohydrate/ Macrocrystalline	Alvogen	Potency & Assay	PR
21 Aug 2019Drug	CLASS II	Macrobid Urinary Tract Anitbacterial, 100 mg recalled by AlvogenMacrobid	Alvogen	Potency & Assay	PR
15 May 2019Drug	CLASS I	Fentanyl Transdermal System, 12 mcg/h, five (12 mcg/h) systems recalledFentanyl System	Alvogen	Packaging Defects	Nationwide
12 Jul 2017Drug	CLASS II	Clindamycin Injection recalled by Alvogen	Alvogen	Sterility	Nationwide
12 Jul 2017Drug	CLASS II	Clindamycin Injection recalled by Alvogen	Alvogen	Sterility	Nationwide
12 Jul 2017Drug	CLASS II	Clindamycin Injection recalled by Alvogen	Alvogen	Sterility	Nationwide
12 Apr 2017Drug	CLASS III	Adalat CC (nifedipine) Extended-Release Tablets, 90 mg recalled	Alvogen	Other	Nationwide
12 Apr 2017Drug	CLASS III	Adalat CC (nifedipine) Extended-Release Tablets, 60 mg recalled	Alvogen	Other	Nationwide
12 Apr 2017Drug	CLASS III	Adalat CC (nifedipine) Extended-Release Tablets, 90 mg recalled	Alvogen	Other	Nationwide
12 Apr 2017Drug	CLASS III	Adalat CC (nifedipine) Extended-Release Tablets, 30 mg recalled	Alvogen	Other	Nationwide
12 Apr 2017Drug	CLASS III	Nifedipine Extended-Release Tablets, 30 mg recalled by Alvogen	Alvogen	Other	Nationwide
12 Apr 2017Drug	CLASS III	Adalat CC (nifedipine) Extended Release Tablets, 60 mg recalled	Alvogen	Other	Nationwide
12 Apr 2017Drug	CLASS III	Adalat CC (nifedipine) Extended Release Tablets 30 mg recalled	Alvogen	Other	Nationwide
12 Apr 2017Drug	CLASS III	Nifedipine Extended-Release Tablets, 60 mg recalled by Alvogen	Alvogen	Other	Nationwide
12 Apr 2017Drug	CLASS III	Nifedipine Extended-Release Tablets, 90 mg recalled by Alvogen	Alvogen	Other	Nationwide
20 May 2015Drug	CLASS II	Nitrofurantoin Monohydrate/Macrocrystals Capsules, 100 mg recalledNitrofurantoin Monohydrate/ Macrocrystalline	Alvogen	Potency & Assay	Nationwide
1 Oct 2014Drug	CLASS II	Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg recalled by Alvogen	Alvogen	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.