# FDA recall F-1380-2015

> **Hi-Tech Pharmacal Co., Inc.** · Class II · food recall initiated 2014-12-23.

## Product

FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059,  NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701

## Reason for recall

Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.

## Distribution

NJ, OH, TX, LA, and Puerto Rico

## Key facts

- **Recall number:** F-1380-2015
- **Recalling firm:** Hi-Tech Pharmacal Co., Inc.
- **Classification:** Class II
- **Product type:** food
- **Status:** Terminated
- **Initiation date:** 2014-12-23
- **Report date:** 2015-03-11
- **Termination date:** 2017-05-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1380-2015

## Citation

> AI Analytics. FDA recall F-1380-2015. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/F-1380-2015. Source: US FDA. Licensed CC0.

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