CLASS III Drug recall · Reported 13 Jul 2016 · FDA Enforcement Report
Sirolimus Tablets, 1 mg recalled by Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is recalling Sirolimus Tablets, 1 mg, distributed nationwide in the US. The recall was initiated on 3 Jun 2016 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-1063-2016
- FDA event ID
- 74325
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Sirolimus
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Jun 2016
- FDA classified
- 5 Jul 2016
- Reported
- 13 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 3 Jun 2016 | Recall initiated by company | |
| 5 Jul 2016 | Classified by FDA | +32 days |
| 13 Jul 2016 | Published in enforcement report | +8 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: out of specification result for impurity secorapamycin.
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, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01
Where it was distributed
Nationwide
Questions about this recall
Is Sirolimus Tablets, 1 mg recalled?
Yes. Dr. Reddy's Laboratories recalled Sirolimus Tablets, 1 mg on 3 Jun 2016. The recall is Class III and its status is Terminated. Recall number D-1063-2016.
Why was it recalled?
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Which lots are affected?
Lot # H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16
Where was it sold?
Nationwide
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 Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | 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 Oral Solution, 1 mg/mL recalled by ApotexSirolimus | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS III | Sirolimus Tablets 1 mg (5 blister cards x doses) recalledSirolimus | American Health Packaging | Potency & Assay | Nationwide |