American Health Packaging recalls Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American
American Health Packaging recalls 1mg Sirolimus tablets due to failed impurities and degradation specifications. Rx-only medication with specific lot and expiration date. Consumers should contact for remedy.
Recall notice
Failed Impurities/Degradation Specifications
Contact the company & request your remedy
What happened, in plain English
American Health Packaging is recalling 1 mg Sirolimus tablets (30 tablets per blister pack) because they failed impurities and degradation tests. This could affect medication safety for patients using these prescription drugs. Read more at govinfonow.com/recall/36143-american-health-packaging-sirolimus-tablets-1mg-recall-failed-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36143-american-health-packaging-sirolimus-tablets-1mg-recall-failed-impurities-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0813-2021
Cite this page
“American Health Packaging Sirolimus Tablets 1mg Recall: Failed Impurities Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36143-american-health-packaging-sirolimus-tablets-1mg-recall-failed-impurities-risk. Based on FDA recall #D-0813-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0813-2021%22&limit=1).
Why it’s dangerous
The tablets failed impurities and degradation specifications, meaning they may contain harmful substances or break down in a way that affects safety. This could lead to medication issues for patients taking them.
Who’s affected
Prescription patients using the recalled Sirolimus tablets. Those with the specific lot number (1000789) and expiration date (10/31/2022) are most at risk.
How to tell if you have this one
Check for the lot number 1000789 and expiration date 10/31/2022 on the packaging. The product is a prescription-only medication with NDC code 68084-915-25.
- Brand
American Health Packaging- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 1000789 and expiration date 10/31/2022 on the packaging.
Questions people ask
Is this product safe to use?
The recall states the tablets failed impurities and degradation specifications, so they may not be safe. Contact the manufacturer for specific guidance.
What should I do if I have this product?
The recall record does not specify a remedy, so contact American Health Packaging for instructions.
How can I tell if I have the recalled product?
Check for the lot number 1000789 and expiration date 10/31/2022 on the packaging.
Contact American Health Packaging
We’ve drafted a message you can send American Health Packaging to request your refund or repair — edit it as you like.
Subject: Recall D-0813-2021 — American Health Packaging American Health Packaging Hello, I own a American Health Packaging that is covered by recall D-0813-2021 from American Health Packaging. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0813-2021 (May 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0813-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.