CLASS III Drug recall · Reported 29 Sep 2021 · FDA Enforcement Report
Sirolimus Tablets 1 mg (5 blister cards x doses) recalled
American Health Packaging is recalling Sirolimus Tablets 1 mg (5 blister cards x doses), distributed nationwide in the US. The recall was initiated on 12 May 2021 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-0813-2021
- FDA event ID
- 88650
- Recalling firm
- American Health Packaging, Columbus, OH
- Brand
- Sirolimus
- Manufacturer
- American Health Packaging
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 May 2021
- FDA classified
- 20 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 12 May 2021 | Recall initiated by company | |
| 20 Sep 2021 | Classified by FDA | +131 days |
| 29 Sep 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
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 Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
Where it was distributed
Nationwide within the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #: 1000789, Exp. Date 10/31/2022
Where was it sold?
Nationwide within 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 26 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 American Health Packaging
All 60| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | American Health Packaging | Potency & Assay | Nationwide |
Other Sirolimus recalls
All 6| 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 | Potency & Assay | 4 states |
| Drug | CLASS III | Sirolimus Oral Solution, 1 mg/mL recalled by ApotexSirolimus | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS III | Sirolimus Tablets, 1 mg recalled by Dr. Reddy's LaboratoriesSirolimus | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Sirolimus, Tablet, 1 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |