Tacrolimus recalls

Tacrolimus products have been recalled 7 times, most recently on 17 Jan 2024. The recalling company is usually Dr. Reddy's Laboratories.

Total recalls7since 2012

Last 12 months0reported

Class I00% of total

Ongoing2latest 17 Jan 2024

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 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 57%Class III 3 43%

Why tacrolimus is recalled

Other Reasons686%
Potency & Assay114%

Companies

Product types

Eye Drops114%

By year

2024114%
2023114%
2022114%
2021114%
2020114%
2014114%
2012114%

Ongoing tacrolimus recalls

2 active

Reported	Class	Recall	Company	Reason	Where
1 Mar 2023Drug	CLASS II	Tacrolimus Capsules, USP, 5 mg recalled by Dr. Reddy's LaboratoriesTacrolimus	Dr. Reddy's Laboratories	Other	Nationwide
10 Aug 2022Drug	CLASS III	Tacrolimus Ointment, 1%, For Dermatological Use Only recalledTacrolimus	Glenmark Pharmaceuticals Inc., U	Other	Nationwide

All tacrolimus recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
17 Jan 2024Drug	CLASS II	Tacrolimus Capsules, USP 1mg recalled by Dr. Reddy's LaboratoriesTacrolimus	Dr. Reddy's Laboratories	Other	Nationwide
1 Mar 2023Drug	CLASS II	Tacrolimus Capsules, USP, 5 mg recalled by Dr. Reddy's LaboratoriesTacrolimus	Dr. Reddy's Laboratories	Other	Nationwide
10 Aug 2022Drug	CLASS III	Tacrolimus Ointment, 1%, For Dermatological Use Only recalledTacrolimus	Glenmark Pharmaceuticals Inc., U	Other	Nationwide
6 Jan 2021Drug	CLASS III	Recalled product recalled by Strides PharmaTacrolimus	Strides Pharma	Other	PA
1 Apr 2020Drug	CLASS III	Tacrolimus Capsules, USP 5mg recalled by Mylan PharmaceuticalsTacrolimus	Mylan Pharmaceuticals	Other	Nationwide
1 Jan 2014Drug	CLASS II	Tacrolimus Capsules, USP, 5 mg recalled by Sandoz IncorporatedTacrolimus	Sandoz Incorporated	Other	Nationwide
5 Dec 2012Drug	CLASS II	Tacrolimus Capsules 5 mg recalled by MylanTacrolimus	Mylan	Potency & Assay	PR

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.