FDA Drug recall D-0995-2019
Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10),…
- FDA Drug
- Class III
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class III recall of Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10),… by Dr Reddy S Laboratories, citing discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0995-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-02-06 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Identifiers
| ndc | 43598-509-30 |
|---|---|
| ndc | 43598-509-90 |
| ndc | 43598-509-10 |
| ndc | 43598-510-30 |
| ndc | 43598-510-90 |
| ndc | 43598-510-10 |
| code_info | Lot #: a) C800589, Exp 5/2019; C706058, Exp 03/2019 Lot #: b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0995-2019%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.