CLASS III Drug recall · Reported 25 May 2022 · FDA Enforcement Report
Sirolimus Oral Solution, 1 mg/mL recalled by Apotex
Apotex is recalling Sirolimus Oral Solution, 1 mg/mL, distributed nationwide in the US. The recall was initiated on 3 May 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0881-2022
- FDA event ID
- 90114
- Recalling firm
- Apotex, Weston, FL
- Brand
- Sirolimus
- Manufacturer
- Apotex Corp
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 May 2022
- FDA classified
- 18 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 3 May 2022 | Recall initiated by company | |
| 18 May 2022 | Classified by FDA | +15 days |
| 25 May 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Sirolimus Oral Solution, 1 mg/mL recalled?
Yes. Apotex recalled Sirolimus Oral Solution, 1 mg/mL on 3 May 2022. The recall is Class III and its status is Terminated. Recall number D-0881-2022.
Why was it recalled?
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Which lots are affected?
Lot: RZ1598, exp. date 02/2023
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Apotex
All 75| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 5mg recalled by Apotex | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
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| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
Other Sirolimus recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Sirolimus Tablets 1mg Tablets recalled by Dr. Reddy's LaboratoriesSirolimus | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Fyarro (sirolimus protein-bound particles recalled by Aadi BioscienceFyarro | Aadi Bioscience | Particulate Matter | 4 states |
| Drug | CLASS III | Sirolimus Tablets 1 mg (5 blister cards x doses) recalledSirolimus | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Sirolimus Tablets, 1 mg recalled by Dr. Reddy's LaboratoriesSirolimus | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |