Heritage Pharmaceuticals, Inc. recalls AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd.,
Heritage Pharmaceuticals recalls Amikacin Sulfate Injection vials due to detected microbial growth in some lots. This poses a risk of infection during medical use. Affected products have specific NDC and lot numbers.
Recall notice
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) .
Contact the company & request your remedy
What happened, in plain English
Heritage Pharmaceuticals is recalling Amikacin Sulfate Injection vials that may contain microbial growth. This could lead to infections if used for medical treatment. Patients and healthcare providers should check their product details and follow the recall instructions. Read more at govinfonow.com/recall/38776-heritage-pharmaceuticals-amikacin-sulfate-injection-recall-microbial-growth-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38776-heritage-pharmaceuticals-amikacin-sulfate-injection-recall-microbial-growth-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1398-2019
Cite this page
“Heritage Pharmaceuticals Amikacin Sulfate Injection Recall: Microbial Growth Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38776-heritage-pharmaceuticals-amikacin-sulfate-injection-recall-microbial-growth-risk. Based on FDA recall #D-1398-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1398-2019%22&limit=1).
Why it’s dangerous
Microbial growth in the injection vials can cause infections when administered to patients. The recall specifically mentions that microbial growth was detected in a sublot of the Amikacin Sulfate Injection product.
Who’s affected
Patients and healthcare providers using the recalled Amikacin Sulfate Injection vials for medical treatment. Those with the specific NDC number 23155-290-32 and lot number VEAC025 are most at risk.
How to tell if you have this one
Check for the NDC number 23155-290-32 and lot number VEAC025 on the vial label. The product is a 4 mL vial of Amikacin Sulfate Injection, USP, 1 gram/4 mL (250 mg/ml), manufactured by Emcure Pharmaceuticals, Ltd.
- Brand
Heritage Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1397-2019 | PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31; Lot: VPCA172, EXP April 2020 | 55,480 2 mL vials | 23155-294-31, 23155-294-42, 23155-294-41 |
| D-1398-2019 | 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; Lot: VEAC025, EXP 10-2019 | 14,960 4 mL vials | 23155-290-31, 23155-290-41, 23155-290-32, 23155-290-42 |
What to do — step by step
Check Product Details
Look for the NDC number 23155-290-32 and lot number VEAC025 on the vial label.
Questions people ask
Is this product safe to use?
The recall indicates microbial growth was detected in some lots, so the product may not be safe. Do not use the recalled vials without checking the recall details.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Heritage Pharmaceuticals for further instructions.
How can I tell if my product is recalled?
Check for the NDC number 23155-290-32 and lot number VEAC025 on the vial label.
Contact Heritage Pharmaceuticals
We’ve drafted a message you can send Heritage Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1398-2019 — Heritage Pharmaceuticals Heritage Pharmaceuticals Hello, I own a Heritage Pharmaceuticals that is covered by recall D-1398-2019 from Heritage Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1398-2019 (May 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1398-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.