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.
Other recalls by Hi Tech Pharmacal
- Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
FDA Food · Class III · 2016-12-28 · Hi Tech Pharmacal - Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
FDA Food · Class III · 2016-12-28 · Hi Tech Pharmacal - HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Ph…
FDA Drug · Class II · 2014-11-05 · Hi Tech Pharmacal - Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc
FDA Drug · Class III · 2014-01-01 · Hi Tech Pharmacal - GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUS…
FDA Drug · Class III · 2013-10-30 · Hi Tech Pharmacal
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.