Sirolimus Oral Solution Recalled for Failed Dissolution Specifications
Apotex Corp. recalls Sirolimus Oral Solution lot RZ1598 for exceeding dissolution specifications at the 14-month timepoint. Approximately 2,353 bottles were distributed nationwide.
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 or injuries. The hazard is a manufacturing quality defect (failed dissolution specifications) without documented harm, making this a precautionary recall.
Plain-English summary
Apotex Corp. is recalling Sirolimus Oral Solution (1 mg/mL, 60 mL bottles) lot RZ1598 (expiration date 02/2023) due to failed dissolution specifications. During testing at the 14-month timepoint, this lot exceeded the specification limit for dissolution.
Sirolimus is a prescription immunosuppressant medication used in transplant recipients. The recall affects 2,353 bottles that were distributed nationwide in the United States.
Patients or caregivers with this medication should contact their healthcare provider or pharmacist for guidance regarding this recall.
The recalled product
- Product
- SIROLIMUS (SIROLIMUS)
- Brand
- SIROLIMUS
- Manufacturer
- Apotex Corp.
- Category
- Drug
- Hazard
- dissolution-failure
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: RZ1598
- exp. date 02/2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · SIROLIMUS
- ModeratePrescription Drug Sirolimus Recalled for Failed Impurity Specifications
FDA (Drugs) · 2024-05-29
- ModerateSirolimus Tablets Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2021-09-29
Same category
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22