Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

FERROUS SULFATE ELIXIR 220 mg/5 mL Recalled by Hi-Tech Pharmacal Co., Inc. Due to Out-of-specification result for pH observed during stability testing...

Date: December 23, 2014
Company: Hi-Tech Pharmacal Co., Inc.
Status: Terminated
Source: FDA (Food)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hi-Tech Pharmacal Co., Inc. directly.

Affected Products

FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701

Quantity: 581 units

Why Was This Recalled?

Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.

Where Was This Sold?

This product was distributed to 4 states: LA, NJ, OH, TX

Affected (4 states)Not affected

About Hi-Tech Pharmacal Co., Inc.

Hi-Tech Pharmacal Co., Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Food). Last updated March 26, 2026. View original report