Prescription Drug Sirolimus Recalled for Failed Impurity Specifications
Dr. Reddy's Laboratories is recalling Sirolimus 1mg tablets nationwide due to failed impurity and degradation specifications. The recall affects 1,176 bottles from lot H2200493 expiring 6/30/2025.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses, injuries, or deaths. The hazard involves failed impurity and degradation specifications, which is a manufacturing quality issue rather than a confirmed safety hazard. Per the severity rubric, Class III recalls with no reported adverse events typically score 1–2.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Sirolimus 1mg tablets due to failed impurities and degradation specifications in the manufacturing process.
The recalled product consists of Sirolimus Tablets 1mg in 100-count bottles, distributed nationwide by Dr. Reddy's Laboratories Inc., based in Princeton, NJ. A total of 1,176 bottles are affected, all from lot H2200493 with an expiration date of 6/30/2025.
Patients and healthcare providers should check if they have the recalled lot (H2200493) using the NDC number 55111-653-01. Anyone with the affected medication should contact their pharmacy or healthcare provider for guidance on treatment options.
The recalled product
- Product
- SIROLIMUS (SIROLIMUS)
- Brand
- SIROLIMUS
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Immunosuppressant
- Hazard
- impurity
- degradation
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 H2200493
- Exp 6/30/2025
UPCs (1)
- 0355111654018
Distribution
Distributed nationwide across the United States.
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