Food, drugs, devices › Hi-Tech Pharmacal Co., Inc.
Food recall: FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 117
Hi-Tech Pharmacal Co., Inc. (Amityville, NY) initiated this food recall on 23 Dec 2014; FDA lists 1 product record under event 70097, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 41% of the 573 food enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 8 May 2017. Initiation: voluntary: firm initiated. Hi-Tech Pharmacal Co., Inc. has 10 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Hi-Tech Pharmacal Co., Inc., Amityville, NY.
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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-1380-2015 | FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701 | 581 units | Class II | Terminated | 11 Mar 2015 |
Context
Other enforcement events for Hi-Tech Pharmacal Co., Inc.
All 10 events for Hi-Tech Pharmacal Co., Inc.
Questions and answers
Why was this food recalled?
FDA's record gives the reason for recall as: "Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "NJ, OH, TX, LA, and Puerto Rico"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 May 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA food enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.