Home / Food recalls / 2015
Hi-Tech Pharmacal Co., Inc.
FDA recall F-1380-2015 · Class II · reported 2015-03-11 · Terminated
- Product
- FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
- Reason
- Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
- Quantity
- 581 units
- Distribution
- NJ, OH, TX, LA, and Puerto Rico
- Firm location
- NY, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Letter
- Recall started
- 2014-12-23
- Terminated
- 2017-05-08
- Code info
- Lot 62110, exp. date 04/2015
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.