Pravastatin Sodium Tablets — Class III drug recall D-1038-2017
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2017-08-09, distributed nationwide. Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C
| Recall number | D-1038-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2017-07-11 |
| Classified | 2017-07-31 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2019-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 544 bottles |
| Reason classes | specification failure |
| NDC | 55111-0229, 55111-0229-01, 55111-0229-05, 55111-0229-30, 55111-0229-90, 55111-0230, 55111-0230-01, 55111-0230-05, 55111-0230-30, 55111-0230-90, 55111-0231, 55111-0231-01, 55111-0231-05, 55111-0231-30, 55111-0231-90, 55111-0274, 55111-0274-01, 55111-0274-05, 55111-0274-30, 55111-0274-90 |
Product
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.
Reason for recall
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1038-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.