Hi-Tech Pharmacal Co., Inc.
Complete recall history across all FDA and CPSC categories — 10 total recalls
Recall Summary
Hi-Tech Pharmacal Co., Inc. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Food Recalls (3)
FDA food safety enforcement actions by Hi-Tech Pharmacal Co., Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 23, 2014 | FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- H... | Out-of-specification result for pH observed during stability testing of Ferro... | Class II |
| Aug 25, 2014 | Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-... | The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ing... | Class III |
| Jul 28, 2014 | Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-... | Out-of-specification results for pH. | Class III |
Drug Recalls (7)
FDA drug safety enforcement actions by Hi-Tech Pharmacal Co., Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 1, 2014 | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (4... | Failed Impurity/Degradation Specification; out-of-specification result for on... | Class II |
| Oct 28, 2013 | Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx onl... | Failed Stability Specification; product viscosity and or pH are below specifi... | Class III |
| Sep 4, 2013 | GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-... | Subpotent; phenylephrine HCl | Class III |
| Jul 25, 2013 | Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL... | Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream U... | Class III |
| Apr 30, 2013 | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL)... | Subpotent; 24 month stability test station | Class III |
| Apr 8, 2013 | BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 m... | Subpotent; Cetylpyridinum Chloride | Class III |
| Mar 11, 2013 | Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co.,... | Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay o... | Class III |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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