FERROUS SULFATE ELIXIR 220 mg/5 mL
Recalling firm: Hi-Tech Pharmacal Co., Inc.
Why it was recalled
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
The exact product
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Check the codes
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Original FDA code information
Lot 62110, exp. date 04/2015
Recall details
- Recall number
- F-1380-2015
- Event ID
- 70097
- FDA status
- Terminated
- Initiated
- Dec 23, 2014
- Reported
- Mar 11, 2015
- Classified
- Mar 3, 2015
- Terminated
- May 8, 2017
- Quantity
- 581 units
- Location
- Amityville, NY, United States
- Initiation type
- Voluntary: Firm initiated
- Notification
- Letter
Where it was distributed
NJ, OH, TX, LA, and Puerto Rico
FDA source record · F-1380-2015
Data updated September 16, 2026. View official FDA data ↗
A missing code match is not a guarantee of safety. Follow official FDA and manufacturer guidance.