Severity
Moderate
ModerateClass IITerminated
FDA Food recall · Reported March 11, 2015
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Compiled from official public sources by the editorial team.
Verify with FDA Food →
Hi-Tech Pharmacal Co., Inc. recalled FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARM… - a moderate-severity action.
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARM… was recalled by Hi-Tech Pharmacal Co., Inc. in March 11, 2015. Reason: Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dos…. Check the official notice for the remedy. Verify recall #F-1380-2015 with the FDA Food before acting.
The recall
Hi-Tech Pharmacal Co., Inc. issued this moderate-severity FDA Food recall-Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dos….
- Moderate
- severity level
- 581 units
- affected scope
- Class II
- classification
- March 11, 2015
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-1380-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-1380-2015) was formally reported on March 11, 2015, with the manufacturer initiating the action on December 23, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Hi-Tech Pharmacal Co., Inc. is listed as the recalling firm, operating out of Amityville, NY. Federal records list the affected scope as 581 units.
The documented reason for this recall is: Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120. Distribution data in the federal record shows the product reached: NJ, OH, TX, LA, and Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 2 from FDA Food - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Food recalls over time
Where this recall sits in its category - 25,126 food recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
581 units
Related Recalls
6
2 from same agency
Product description
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Reason for recall
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-1380-2015 |
| Date reported | March 11, 2015 |
| Date initiated | December 23, 2014 |
| Recalling firm | Hi-Tech Pharmacal Co., Inc. |
| Firm location | Amityville, NY |
| Affected scope | 581 units |
| Distribution | NJ, OH, TX, LA, and Puerto Rico |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-1380-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701. Recalled by Hi-Tech Pharmacal Co., Inc.. Units affected: 581 units.
Why was this product recalled? ▼
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on March 11, 2015. Severity: Moderate. Recall number: F-1380-2015.
Where was the recalled product distributed? ▼
Distribution: NJ, OH, TX, LA, and Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-1380-2015) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported March 11, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.