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SupplierTrail

Hi-Tech Pharmacal Co., Inc.

FEI 2433247 · United States

Per FDA, as of 2026-10-31 · Sources: FDA Data Dashboard, Import Alerts, Enforcement Reports

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Import alerts
0
Import refusals (5 years)
0
Warning letters
0
Last FDA action
2014-12-23
11 years ago

FDA record

  1. 2014-12-23
    RecallRecall F-1380-2015 · Class 2 · Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
    FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
    Source: FDA Enforcement Reports
  2. 2014-08-25
    RecallRecall F-0820-2017 · Class 3 · The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.
    Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
    Source: FDA Enforcement Reports
  3. 2014-07-28
    RecallRecall F-0817-2017 · Class 3 · Out-of-specification results for pH.
    Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
    Source: FDA Enforcement Reports
  4. 2011-03-09
    RecallRecall F-1614-2011 · Class 3 · Presence of precipitate which was identified as undissolved biotin, a raw material present in the finished product formulation.
    GOLDEN AGE COMPLETE LIQUID FORMULA, HIGH POTENCY, MULTIVITAMIN, MULTIMINERAL, 8 fl oz (237mL), Rx CHOICE label, NDC 50383-786-08 (Barcode 3-50383-786-08-5), HI-TECH PHARMACAL Co., INC. AMITYVILLE, NY 11701. The product is also contract man…
    Source: FDA Enforcement Reports