Lower risk Drug recall · FDA · Published May 3, 2022

Apotex Sirolimus Oral Solution Recall: Failed Dissolution Specifications

Apotex recalls Sirolimus Oral Solution (1 mg/mL, 60mL) due to failed dissolution specifications in one lot. This may affect medication effectiveness. Check your product details to see if it's affected.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0881-2022Drug Apotex ›

Lower-risk recall

Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

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Contact the company

Recalling firmApotex Corp.2400 N Commerce Pkwy Ste 400 · Weston, FL 33326-3253

✎ GovInfoNow plain-language explainer

Apotex is recalling a specific lot of Sirolimus Oral Solution because it failed dissolution tests at 14 months. This could mean the medication isn't working properly for patients who need it. Read more at govinfonow.com/recall/34797-apotex-sirolimus-oral-solution-recall-failed-dissolution-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/34797-apotex-sirolimus-oral-solution-recall-failed-dissolution-specifications · Updated August 18, 2026 · FDA enforcement record: FDA #D-0881-2022

Cite this page

“Apotex Sirolimus Oral Solution Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34797-apotex-sirolimus-oral-solution-recall-failed-dissolution-specifications. Based on FDA recall #D-0881-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0881-2022%22&limit=1).

The FDA announced on May 3, 2022, that Apotex Corp. voluntarily recalled Sirolimus Oral Solution due to failed dissolution specifications. The recall affects one lot distributed nationwide in the United States.

How to tell if you have it

Brand: Apotex
Product: Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle
NDC: 60505-6197-2
Lot: RZ1598
Expiration date: 02/2023
Quantity: 2353 bottles
Distribution: Nationwide in the USA

The hazard

The recall is due to Sirolimus Oral Solution lot RZ1598 exceeding the specification limit at the 14-month timepoint. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Apotex Corp. has 24 other recalls on record since June 14, 2007. Other recent recalls of similar products include AvKARE Amantadine Capsules Recall (Feb. 13, 2026), Sun Pharmaceutical Lisdexamfetamine Capsules Recall (Oct. 28, 2025) and Lannett Niacin Extended-release Tablets Recall (May 27, 2026).

How to tell if you have this one

Check for the product name 'Sirolimus Oral Solution', 1 mg/mL, 60 mL bottle, and the lot number RZ1598. The expiration date is February 2023.

Brand
Apotex
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot number RZ1598 on the label to confirm if your medication is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

May 3, 2022Firm started the recall
May 18, 2022FDA classified it Class III
May 25, 2022Published in FDA’s Enforcement Report
Oct 5, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Apotex recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/34797-apotex-sirolimus-oral-solution-recall-failed-dissolution-specifications">Apotex Sirolimus Oral Solution Recall: Failed Dissolution Specifications (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0881-2022 (May 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0881-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.