Prescription Tacrolimus Capsules Recalled for Wrong-Strength Product Mix
Dr. Reddy's Laboratories is recalling 8,280 bottles of Tacrolimus 1 mg capsules after a 0.5 mg capsule was found in a bottle. The wrong-strength capsule could cause dosage confusion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall with no reported illnesses or injuries, but the hazard poses significant risk of harm. A wrong-strength capsule in a prescription immunosuppressant could cause serious dosage errors. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Tacrolimus Capsules, USP 1 mg (lot C2307275, expiring January 2026). The recall involves 8,280 bottles distributed nationwide.
During quality control, one 0.5 mg Tacrolimus capsule was found in a bottle labeled as containing 1 mg capsules. The presence of this wrong-strength capsule creates a risk of dosage error if not detected by patients, caregivers, or healthcare providers.
Patients with bottles from this lot should check their medication and contact their healthcare provider or pharmacist if they suspect they may have received an affected bottle. Pharmacy staff should identify and quarantine bottles from lot C2307275.
The recalled product
- Product
- TACROLIMUS (TACROLIMUS)
- Brand
- TACROLIMUS
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Hazard
- wrong-strength
- product-mix
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# C2307275
- Exp. January 2026
UPCs (3)
- 0355111527015
- 0355111525011
- 0355111526018
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · TACROLIMUS
- HighTacrolimus Capsules Recalled for Wrong-Strength Tablets Co-Mingled in Bottles
FDA (Drugs) · 2023-03-01
- LowTacrolimus Ointment Recalled for Defective Containers That Split
FDA (Drugs) · 2022-08-10
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27