Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
AMIKACIN SULFATE INJECTION Recalled by Heritage Pharmaceuticals, Inc. Due to Non-Sterility:Microbial growth detected in sub lot of Amikacin...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Heritage Pharmaceuticals, Inc. directly.
Affected Products
AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32
Quantity: 14,960 4 mL vials
Why Was This Recalled?
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Heritage Pharmaceuticals, Inc.
Heritage Pharmaceuticals, Inc. has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report