Hi-Tech Pharmacal Co., Inc. FDA recall records
The FDA has published 3 food recall enforcement records naming Hi-Tech Pharmacal Co., Inc. between 2015 and 2016, covering 3 separate recall events. The firm is recorded in New York. Data last updated 2 September 2026.
- Records of 29,386
- 3
- Share of all recalls
- 0%
- Class I of 3
- 0
- Reported between
- 2015 to 2016
What these records are
Every record on this page was published by the FDA in the openFDA food enforcement database. 3 records cover 3 recall events, because the agency opens one record per product code: a single recall of a product line with many codes appears here many times.
0 of these records are Class I, 1 Class II and 2 Class III. A recall count is not a safety score. Most FDA food recalls are initiated by the firm itself, and a recall is the firm removing product from the market, which is what a food safety plan is built to produce.
By year
Counts are by the date the FDA reported the enforcement action. That date runs behind the date a firm started a recall, so the most recent year is always partial.
Where the recalling firms are
The state is the location of the recalling firm, not where the product was sold. Distribution is recorded separately on each record.
Most recently reported
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2016-12-28 | Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 | Hi-Tech Pharmacal Co., Inc. | Out-of-specification results for pH. | Class III |
| 2016-12-28 | Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 | Hi-Tech Pharmacal Co., Inc. | The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label. | Class III |
| 2015-03-11 | FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701 | Hi-Tech Pharmacal Co., Inc. | Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120. | Class II |
Questions
- How many FDA recalls has Hi-Tech Pharmacal Co., Inc. had?
- The FDA has published 3 food recall enforcement records naming Hi-Tech Pharmacal Co., Inc. between 2015 and 2016. Those records cover 3 separate recall events: the agency opens one record per product code, so one recall of a product line appears as many records.
- Does a high recall count mean a firm is unsafe?
- Not on its own. Most FDA food recalls are initiated voluntarily by the firm, and a recall is the firm removing product from the market, which is what a working food safety plan is supposed to produce. Record counts also scale with the number of product codes a firm carries rather than with the number of things that went wrong.
A recall is the end of an evidence trail that either existed or did not. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.