FDA Drug recall D-0504-2024
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India,…
- FDA Drug
- Class III
- ongoing
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class III recall of Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India,… by Dr Reddy S Laboratories, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0504-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-05-01 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
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
Reason
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 55111-653-30 |
|---|---|
| ndc | 55111-653-01 |
| ndc | 55111-654-30 |
| ndc | 55111-654-01 |
| code_info | Lot H2200493; Exp 6/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2025-07-23 · Dr Reddy S Laboratories - Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyd…
FDA Drug · Class I · 2025-04-23 · Dr Reddy S Laboratories - Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ…
FDA Drug · Class III · 2024-12-18 · Dr Reddy S Laboratories
All Dr Reddy S Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0504-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.