FDA Food recall F-1380-2015
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
- FDA Food
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701 by Hi Tech Pharmacal, citing out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Read the official FDA Food notice
| Agency | FDA Food |
|---|---|
| Recall number | F-1380-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-23 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:49 UTC |
| Company | Hi Tech Pharmacal |
| Distribution | LA, NJ, OH, PR, TX |
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.
Identifiers
| upc | 350838778059 |
|---|---|
| code_info | Lot 62110, exp. date 04/2015 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:49 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-1380-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.