CLASS II Food recall · Reported 11 Mar 2015 · FDA Enforcement Report
Ferrous Sulfate Elixir 220 mg recalled by Hi-Tech Pharmacal Co
Hi-Tech Pharmacal is recalling Ferrous Sulfate Elixir 220 mg, distributed in Louisiana, New Jersey, Ohio, Puerto Rico, Texas. The recall was initiated on 23 Dec 2014 and the FDA has classified it as Class II.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- F-1380-2015
- FDA event ID
- 70097
- Recalling firm
- Hi-Tech Pharmacal, Amityville, NY
- Brand
- Ferrous Sulfate
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2014
- FDA classified
- 3 Mar 2015
- Reported
- 11 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Product category
- Herbal Supplements
Timeline
| 23 Dec 2014 | Recall initiated by company | |
| 3 Mar 2015 | Classified by FDA | +70 days |
| 11 Mar 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Where it was distributed
NJ, OH, TX, LA, and Puerto Rico
Questions about this recall
Why was it recalled?
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Which lots are affected?
Lot 62110, exp. date 04/2015
Where was it sold?
NJ, OH, TX, LA, and Puerto Rico
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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