Omeprazole Delayed-Release Capsules — Class II drug recall D-0308-2021
Terminated recall by Breckenridge Pharmaceutical, Inc, reported 2021-03-24, distributed nationwide. Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities dur
| Recall number | D-0308-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breckenridge Pharmaceutical, Inc, Berlin, CT, United States |
| Recall initiated | 2021-03-11 |
| Classified | 2021-03-18 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2022-03-23 |
| Distributed | Nationwide (US) |
| Quantity | 3,146 bottles |
| Reason classes | specification failure |
| NDC | 51991-0643-10 |
| Lot numbers | 191659 |
| Expiration dates | 2021-05 |
Product
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
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-0308-2021. 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.