FERROUS SULFATE ELIXIR 220 mg/5 mL — Class II food recall F-1380-2015
Terminated recall by Hi-Tech Pharmacal Co., Inc., reported 2015-03-11, distributed in LA, NJ, OH, PR, TX. Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose
| Recall number | F-1380-2015 |
|---|---|
| Product type | Food |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hi-Tech Pharmacal Co., Inc., Amityville, NY, United States |
| Recall initiated | 2014-12-23 |
| Classified | 2015-03-03 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2017-05-08 |
| Distributed | LA, NJ, OH, PR, TX |
| Quantity | 581 units |
| Reason classes | specification failure |
| NDC | 50383-0778-05 |
| Lot numbers | 62110 |
| Expiration dates | 2015-04 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/F-1380-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.