Esomeprazole Magnesium Delayed-Release Capsules USP — Class III drug recall D-0995-2019
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2019-02-20, distributed nationwide. Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
| Recall number | D-0995-2019 |
|---|---|
| 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 | 2019-02-06 |
| Classified | 2019-03-12 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2021-01-26 |
| Distributed | Nationwide (US) |
| NDC | 43598-0509, 43598-0509-10, 43598-0509-30, 43598-0509-90, 43598-0510, 43598-0510-10, 43598-0510-30, 43598-0510-90 |
| Expiration dates | 2019-02, 2019-03, 2019-05, 2019-06 |
Product
Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.
Reason for recall
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
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-0995-2019. 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.