FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

Start Over | Back to Previous Screen

Tacrolimus Capsules
Status: Currently in Shortage
»Date first posted: 05/17/2019
»Therapeutic Categories: Transplant

Expand all

Accord Healthcare Inc. (Revised 09/14/2020)

Company Contact Information:
866-941-7875, option 2

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg 100 count (NDC 1672904101) Limited supply availability. Product will be allocated until Q1 2021 Limited API availability
1 mg 100 count (NDC 1672904201) Limited supply availability. Product will be allocated until Q1 2021 Limited API availability
5 mg 100 count (NDC 1672904301) Limited supply availability. Product will be allocated until Q1 2021 Limited API availability

Astellas (Reverified 09/11/2020)

Company Contact Information:
800-727-7003

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
PROGRAF® (tacrolimus) capsules 0.5 mg 100 count bottle (NDC 0469-0607-73) Available
PROGRAF® (tacrolimus) capsules 5 mg 100 count bottle (NDC 0469-0657-73) Available
PROGRAF® (tacrolimus) capsules 1 mg 100 count bottle (NDC 0469-0617-73) Available
ASTAGRAF XL® (tacrolimus extended release capsules) 0.5 mg 30 count bottle (NDC 0469-0647-73) Available
ASTAGRAF XL® (tacrolimus extended release capsules) 1 mg 30 count bottle (NDC 0469-0677-73) Available
ASTAGRAF XL® (tacrolimus extended release capsules) 5 mg 30 count bottle (NDC 0469-0687-73) Available
PROGRAF® Granules (tacrolimus for oral suspension) 0.2 mg unit dose packets (NDC 0469-1230-50) Available
PROGRAF® Granules (tacrolimus for oral suspension) 1 mg unit dose packets (NDC 0469-1330-50) Available

BPI Labs, LLC (Reverified 09/09/2020)

Company Contact Information:
727-471-0850 ext. 275

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1 mg 100 count bottle (NDC 54288-135-01) Available

Dr. Reddy's Laboratories, Inc. (Reverified 09/21/2020)

Company Contact Information:
866-733-3952

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg (NDC 55111-525-01) Can only supply contracted customers Manufacturer extended lead times. Demand increase for the drug
1 mg (NDC 55111-526-01) Can only supply contracted customers Manufacturer extended lead times. Demand increase for the drug
5 mg (NDC 55111-527-01) Can only supply contracted customers Manufacturer extended lead times. Demand increase for the drug

Mylan Pharmaceuticals Inc. (Reverified 09/16/2020)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg, 100s (NDC 0378-2045-01) Available
1 mg, 100s (NDC 0378-2046-01) Unavailable, recovery in September 2020
5 mg, 100s (NDC 0378-2047-01) Unavailable, recovery in September 2020

Sandoz (Reverified 09/15/2020)

Company Contact Information:
800-525-8747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg 100 count bottle (NDC 0781-2102-01) Supply Available; intermittent backorder until March 2021 Demand increase for the drug
1 mg 100 count bottle (NDC 0781-2103-04) Supply Available; intermittent backorder until March 2021 Demand increase for the drug
5 mg 100 count bottle (NDC 0781-2104-01) Supply Available; intermittent backorder until March 2021 Demand increase for the drug

Strides Pharma Inc. (Revised 09/08/2020)

Company Contact Information:
855-273-0146

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1 mg 100 count bottles (NDC 64338-721-06) Available
0.5 mg 100 count bottles (NDC 64380-720-06) Currently, we do not distribute this product strength and NDC. We anticipate product will be available by the end of September or early October 2020.
5 mg 100 count bottles (NDC 64380-722-06) Currently, we do not distribute this product strength and NDC. We anticipate product will be available by the end of September or early October 2020.

Veloxis Pharmaceuticals, Inc. (Reverified 05/07/2020)

Company Contact Information:
919-591-3085

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Envarsus XR 0.75 mg Extended-Release Tablets 30 count (NDC 68992-3075-3) Available
Envarsus XR 0.75 mg Extended-Release Tablets 100 count (NDC 68992-3075-1) Available
Envarsus XR 1 mg Extended-Release Tablets 30 count (NDC 68992-3010-3) Available
Envarsus XR 1 mg Extended-Release Tablets 100 count (NDC 68992-3010-1) Available
Envarsus XR 4 mg Extended-Release Tablets 30 count (NDC 68992-3040-3) Available
Envarsus XR 4 mg Extended-Release Tablets 100 count (NDC 68992-3040-1) Available

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English