Hi-Tech Pharmacal recalls Ferrous Sulfate Elixir 220mg/5mL due to pH instability during testing. This may affect product safety. Check your product's lot number and expiration date.
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Hi-Tech Pharmacal is recalling Ferrous Sulfate Elixir 220 mg/5 mL products that were manufactured in Lot 621120. The issue involves pH instability during stability testing, which could potentially affect product safety.
The product was found to have an out-of-specification pH result during stability testing. This could mean the medication may not be as effective or safe as intended over time, though the exact risk is not specified in the recall notice.
People who have purchased or used Ferrous Sulfate Elixir 220 mg/5 mL products with the specific lot number 621120 are affected. Those taking this medication for iron deficiency should be most concerned.
Check for the product name 'Ferrous Sulfate Elixir 220 mg/5 mL', UPC 350838778059, and NDC 50383-778-05. The affected lot number is 621120 with an expiration date of 04/2015.
Look for the product name, UPC, NDC, and lot number on the label to confirm if it's affected.
The recall notice states there was an out-of-specification pH result during stability testing, but it does not specify if the product is unsafe to use.
The recall notice does not provide a remedy or specific action steps for affected products.
Check the product's lot number; affected products have lot number 621120 with an expiration date of 04/2015.
We’ve drafted a message you can send Hi-Tech Pharmacal to request your refund or repair — edit it as you like.
Subject: Recall F-1380-2015 — Hi-Tech Pharmacal Hi-Tech Pharmacal Hello, I own a Hi-Tech Pharmacal that is covered by recall F-1380-2015 from Hi-Tech Pharmacal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
