CLASS III ONGOING Drug recall · Reported 29 May 2024 · FDA Enforcement Report
Sirolimus Tablets 1mg Tablets recalled by Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is recalling Sirolimus Tablets 1mg Tablets, distributed nationwide in the US. The recall was initiated on 1 May 2024 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-0504-2024
- FDA event ID
- 94535
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Sirolimus
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 1 May 2024
- FDA classified
- 21 May 2024
- Reported
- 29 May 2024
- Type
- Voluntary: Firm initiated
- Reason category
- Potency & Assay
Timeline
| 1 May 2024 | Recall initiated by company | |
| 21 May 2024 | Classified by FDA | +20 days |
| 29 May 2024 | 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 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 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot H2200493; Exp 6/30/2025
Where was it sold?
US 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 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 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 0.75% 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 Oral Solution, 1 mg/mL recalled by Apotex | Apotex | Potency & Assay | Nationwide |
| 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 |
| Drug | CLASS II | Sirolimus, Tablet, 1 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |