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Varenicline Tartrate recalls

Varenicline Tartrate products have been recalled 1 time, most recently on 17 Dec 2025. The recalling company is usually Dr. Reddy's Laboratories. The most common reason is potency & assay.

Total recalls1since 2025

Last 12 months1reported

Class I00% of total

Ongoing1latest 17 Dec 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 1 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 0 0%Class III 1 100%

Why varenicline tartrate is recalled

Potency & Assay1100%

Companies

Dr. Reddy's Laboratories1100%

By year

20251100%

Ongoing varenicline tartrate recalls

1 active

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025Drug	CLASS III	Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate	Dr. Reddy's Laboratories	Potency & Assay	Nationwide

All varenicline tartrate recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025Drug	CLASS III	Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate	Dr. Reddy's Laboratories	Potency & Assay	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.