FDA Drug recall D-0026-2022
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a ca…
- FDA Drug
- Class II
- terminated
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a ca… by Dr Reddy S Laboratories, citing CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0026-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-05 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
Reason
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Identifiers
| ndc | 70000-0232-1 |
|---|---|
| ndc | 70000-0232-2 |
| ndc | 70000-0232-3 |
| code_info | BT001594C |
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-0026-2022%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.