Recalls / Active ingredient / Tacrolimus

Tacrolimus

9 FDA drug recalls involving the active ingredient “Tacrolimus” — 2 Class I.

Date	Class	Product	Firm
2024-12-23	Class I	Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distri	Astellas Pharma US Inc.
2024-12-23	Class I	Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astel	Astellas Pharma US Inc.
2023-12-15	Class II	Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, B	Dr. Reddy's Laboratories, Inc.
2023-02-08	Class II	Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupa	Dr. Reddy's Laboratories, Inc.
2022-07-11	Class III	Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 684	Glenmark Pharmaceuticals Inc., USA
2020-12-22	Class III	NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd	Strides Pharma Inc.
2020-03-23	Class III	Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC	Mylan Pharmaceuticals Inc.
2013-10-22	Class II	Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. f	Sandoz Incorporated
2012-06-29	Class II	Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505	Mylan LLC.