Sandoz Recalls Tacrolimus Capsules Due to Fluvastatin Cross-Contamination
Sandoz Incorporated is recalling specific lots of Tacrolimus Capsules because trace amounts of fluvastatin were found in the product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe).
Plain-English summary
Sandoz Incorporated is recalling 12,521 bottles of Tacrolimus Capsules, USP, 0.5 mg. The affected product is a prescription-only medication manufactured in India by Sandoz Private Ltd. for Sandoz Inc. The recall covers lots DE9898, DE9900, DE9903, DE9908, and DE9911, all with an expiration date of 06/14.
The recall was initiated due to cross-contamination with other products. Specifically, findings indicated the carryover of trace amounts of fluvastatin, a previously manufactured product, into the Tacrolimus capsules. The affected products were distributed nationwide.
Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider for guidance. The FDA classifies this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- TACROLIMUS (TACROLIMUS)
- Brand
- TACROLIMUS
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Prescription Drug
- Affected units
- 12,521
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 (5)
- Lots DE9898
- DE9900
- DE9903
- DE9908
- DE9911. Exp. 06/14
UPCs (3)
- 0307812103012
- 0307812102015
- 0307812104019
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · TACROLIMUS
- HighPrescription Tacrolimus Capsules Recalled for Wrong-Strength Product Mix
FDA (Drugs) · 2024-01-17
- 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
- LowStrides Pharma Recalls Tacrolimus Capsules for Failed Moisture Limits
FDA (Drugs) · 2021-01-06
- ModerateMylan Recalls Tacrolimus Capsules Due to Potential Foreign Capsule Presence
FDA (Drugs) · 2020-04-01
Same manufacturer · Sandoz Incorporated
See all →- ModerateSandoz Recalls Triamterene and Hydrochlorothiazide Tablets Due to Cross-Contamination
FDA (Drugs) · 2018-04-25
- ModerateSandoz Recalls Amitriptyline Hydrochloride Tablets Due to Cross-Contamination
FDA (Drugs) · 2017-07-12
- ModerateSandoz Recalls Nadolol Tablets Due to Failed Dissolution Test
FDA (Drugs) · 2017-01-04
- LowSandoz Recalls Fluoxetine Capsules Due to Illegible Logo
FDA (Drugs) · 2014-12-17
- SevereSandoz Recalls Alprazolam Tablets Due to Stainless Steel Particulates
FDA (Drugs) · 2014-08-06
Same hazard · cross contamination
See all →- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- ModerateSage Products Recalls Chlorhexidine Gluconate Cloth Due to Cross Contamination
FDA (Drugs) · 2026-09-09
- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29
Similar recalls
- ModerateSandoz Recalls Nitrofurantoin Capsules Due to Cross Contamination
FDA (Drugs) · 2018-11-21
- LowSandoz Recalls Nitrofurantoin Capsules Due to Cross-Contamination
FDA (Drugs) · 2018-11-21
- ModerateFDA Recalls Temozolomide Capsules Due to Cross-Contamination Risk
FDA (Drugs) · 2019-07-31
- ModerateMylan Recalls Tacrolimus Capsules Due to Potential Foreign Capsule Presence
FDA (Drugs) · 2020-04-01
- ModerateSandoz Recalls Triamterene and Hydrochlorothiazide Tablets Due to Cross-Contamination
FDA (Drugs) · 2018-04-25
- LowSandoz Recalls Fluoxetine Capsules Due to Illegible Logo
FDA (Drugs) · 2014-12-17