Hi-Tech Pharmacal Recalls Ferrous Sulfate Elixir Due to pH Issues
Hi-Tech Pharmacal is recalling 581 units of Ferrous Sulfate Elixir because stability testing showed out-of-specification pH results.
The agency’s classification
FDA (Food): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling or quality control issue (pH) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Hi-Tech Pharmacal Co., Inc. is recalling 581 units of Ferrous Sulfate Elixir 220 mg/5 mL (NDC 50383-778-05, UPC 350838778059). The recall was initiated after out-of-specification results for pH were observed during stability testing of the product.
The affected product is identified as Lot 62110 with an expiration date of 04/2015. The recall is classified as FDA Class II. The product was distributed in New Jersey, Ohio, Texas, Louisiana, and Puerto Rico.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is precautionary, and no illnesses or injuries have been reported in connection with this product.
The recalled product
- Product
- FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
- Manufacturer
- Hi-Tech Pharmacal Co., Inc.
- Category
- Drug — Liquid Supplement
- Hazard
- Affected units
- 581
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 62110
- exp. date 04/2015
Distribution
Related recalls
Same manufacturer · Hi-Tech Pharmacal Co., Inc.
See all →- LowHi-Tech Pharmacal Recalls Liquid Vitamin C Due to Low Active Ingredient
FDA (Food) · 2016-12-28
- LowHi-Tech Pharmacal Recalls Liquid Vitamin C Due to pH Issues
FDA (Food) · 2016-12-28
- SevereHi-Tech Pharmacal Recalls HydrOXYzine Hydrochloride Oral Solution Due to Impurity
FDA (Drugs) · 2014-11-05
- LowHi-Tech Pharmacal Recalls Acyclovir Oral Suspension for Stability Failures
FDA (Drugs) · 2014-01-01
- ModerateHi-Tech Pharmacal Recalls Subpotent Giltuss and Exactuss Cough Medicines
FDA (Drugs) · 2013-10-30
Same hazard · quality control
See all →- HighBaxter Recalls CARDENE IV Nicardipine Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls MYXREDLIN Insulin Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- LowHi-Tech Pharmacal Recalls Acyclovir Oral Suspension for Stability Failures
FDA (Drugs) · 2014-01-01
- LowHi-Tech Pharmacal Recalls Liquid Vitamin C Due to pH Issues
FDA (Food) · 2016-12-28
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateHi-Tech Pharmacal Recalls Subpotent HydrOXYzine Hydrochloride Oral Solution
FDA (Drugs) · 2013-06-26
- ModeratePharmatech Recalls Ferrous Sulfate Liquid Due to Potential Contamination
FDA (Food) · 2016-11-02
- SevereRugby Ferrous Sulfate Elixir Recalled for Yeast and B. cepacia Contamination
FDA (Food) · 2018-01-31