Tacrolimus recalls

The FDA has published 15 recalls involving Tacrolimus since 2012. The latest was reported on 5 Feb 2025. Aidapak Services has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls15since 2012

Last 12 months0reported

Class I213% of total

Ongoing5latest 5 Feb 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 2Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 2 13%Class II 10 67%Class III 3 20%

Why tacrolimus is recalled

Companies

Brands

By year

2025213%
202417%
202317%
202217%
202117%
202017%
201717%
2014427%
2013213%
201217%

Ongoing tacrolimus recalls

5 active

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Drug	CLASS I	Astagraf XL (tacrolimus extended-release capsules) 0.5 mg recalledAstagraf Xl	Astellas Pharma US	Packaging Defects	Nationwide
5 Feb 2025Drug	CLASS I	Prograf (tacrolimus) capsules, USP, 0.5 mg recalledPrograf	Astellas Pharma US	Packaging Defects	Nationwide
1 Mar 2023Drug	CLASS II	Tacrolimus Capsules, USP, 0.5 mg recalled by Dr. Reddy's LaboratoriesTacrolimus	Dr. Reddy's Laboratories	Other	Nationwide
10 Aug 2022Drug	CLASS III	Tacrolimus Ointment, 0.1%, For Dermatological Use Only recalledTacrolimus	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
17 Jul 2013Drug	CLASS II	Tacrolimus (0.02% and 0.03%) drops recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

All tacrolimus recalls, newest first

15 total

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Drug	CLASS I	Astagraf XL (tacrolimus extended-release capsules) 0.5 mg recalledAstagraf Xl	Astellas Pharma US	Packaging Defects	Nationwide
5 Feb 2025Drug	CLASS I	Prograf (tacrolimus) capsules, USP, 0.5 mg recalledPrograf	Astellas Pharma US	Packaging Defects	Nationwide
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, 0.5 mg recalled by Dr. Reddy's LaboratoriesTacrolimus	Dr. Reddy's Laboratories	Other	Nationwide
10 Aug 2022Drug	CLASS III	Tacrolimus Ointment, 0.1%, For Dermatological Use Only recalledTacrolimus	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
6 Jan 2021Drug	CLASS III	Strides Pharma products recalledTacrolimus	Strides Pharma	Other	PA
1 Apr 2020Drug	CLASS III	Tacrolimus Capsules, USP 5mg recalled by Mylan PharmaceuticalsTacrolimus	Mylan Pharmaceuticals	Other	Nationwide
22 Mar 2017Drug	CLASS II	Tacrolimus 0.1% Ointment and Tacrolimus 0.1%/Ketoconazole recalled	Synergy Rx	Sterility	Nationwide
29 Jan 2014Drug	CLASS II	Tacrolimus, Capsule, 0.5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
29 Jan 2014Drug	CLASS II	Tacrolimus, Capsule, 1 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Tacrolimus Capsule, 1 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
1 Jan 2014Drug	CLASS II	Tacrolimus Capsules, USP, 0.5 mg recalled by Sandoz	Sandoz	Other	Nationwide
21 Aug 2013Drug	CLASS II	Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA recalled	Pallimed Solutions	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Tacrolimus (0.02% and 0.03%) drops recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
5 Dec 2012Drug	CLASS II	Tacrolimus Capsules 0.5 mg recalled by MylanTacrolimus	Mylan	Potency & Assay	PR

Should you stop taking Tacrolimus?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.