Prograf Tacrolimus Capsules Recall: Empty Capsules in Bottles
Astellas Pharma recalls Prograf (tacrolimus) 0.5 mg capsules distributed nationwide due to empty capsules in bottles. Affected lot 0E3353D expires March 31, 2026.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification indicates a reasonable probability of serious adverse health consequences. Empty capsules prevent patients from receiving prescribed medication, creating substantial risk of serious harm.
Plain-English summary
Astellas Pharma US Inc. is recalling Prograf (tacrolimus) 0.5 mg capsules due to failed tablet/capsule specifications. Bottles shipped nationwide in the USA may contain empty capsules instead of the active medication. The affected lot is 0E3353D with an expiration date of March 31, 2026.
Approximately 14,340 100-count bottles have been distributed nationwide. Empty capsules mean the intended medication is not present, preventing patients from receiving their full prescribed dosage.
Patients, pharmacists, and healthcare providers should immediately check if they have received bottles from lot 0E3353D. Individuals with affected bottles should contact their healthcare provider or pharmacist for guidance on how to proceed. Do not use capsules from affected bottles if empty capsules are observed.
The recalled product
- Product
- PROGRAF (TACROLIMUS)
- Brand
- PROGRAF
- Manufacturer
- Astellas Pharma US Inc.
- Category
- Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 0E3353D
- Exp 03/31/2026
UPCs (6)
- 0304690607731
- 0304690657736
- 0304691230501
- 0304691330508
- 0304690617730
- 0304693016011
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Astellas Pharma US Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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