# FDA recall D-0835-2020

> **Pfizer Inc.** · Class II · drug recall initiated 2020-02-03.

## Product

Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).

## Reason for recall

Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.

## Distribution

Nationwide in the U.S. and Puerto Rico

## Key facts

- **Recall number:** D-0835-2020
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-02-03
- **Report date:** 2020-02-19
- **Termination date:** 2022-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0835-2020

## Citation

> AI Analytics. FDA recall D-0835-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0835-2020. Source: US FDA. Licensed CC0.

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