# FDA recall D-0308-2021

> **Breckenridge Pharmaceutical, Inc** · Class II · drug recall initiated 2021-03-11.

## 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.

## Distribution

Product was distributed nationwide

## Key facts

- **Recall number:** D-0308-2021
- **Recalling firm:** Breckenridge Pharmaceutical, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-11
- **Report date:** 2021-03-24
- **Termination date:** 2022-03-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Berlin, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0308-2021

## Citation

> AI Analytics. FDA recall D-0308-2021. Retrieved 2026-07-30 from https://api.ai-analytics.org/recall/D-0308-2021. Source: US FDA. Licensed CC0.

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