CLASS I Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Amikacin Sulfate Injection, USP (250 mg/ml) vial recalled
Heritage Pharmaceuticals is recalling Amikacin Sulfate Injection, USP (250 mg/ml) vial, distributed nationwide in the US. The recall was initiated on 21 May 2019 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1398-2019
- FDA event ID
- 82918
- Recalling firm
- Heritage Pharmaceuticals, East Brunswick, NJ
- Brand
- Amikacin Sulfate
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 May 2019
- FDA classified
- 19 Jun 2019
- Reported
- 19 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 21 May 2019 | Recall initiated by company | |
| 19 Jun 2019 | Classified by FDA | +29 days |
| 19 Jun 2019 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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) .
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it 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) .
Which lots are affected?
Lot: VEAC025, EXP 10-2019
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 82918| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Prochlorperazine Edisylate Injection, USP 10 mg/ (5mg/mL) Vial recalledProchlorperazine Edisylate | Heritage Pharmaceuticals | Sterility | Nationwide |
More recalls from Heritage Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Palmitate Hydrochloride For Oral Solution, USP, 75 mg recalledClindamycin Palmitate Hydrochloride | Heritage Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 75 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 100 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 50 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 10 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Other Amikacin recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amikacin 450MG IN NS, Antibiotic, used in a Homepump recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Amikacin Sulfate Injection USP (250mg/ML) single-dose vials recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Amikacin Sulfate Injection, USP, 1 gm/ (250 mg/mL) recalled | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Amikacin Sulfate Injection, USP, 500 mg/ (250 mg/mL) recalled | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Amikacin Sulfate injection USP,1 gm/ (250 mg/mL) vial recalled | Teva Pharmaceuticals USA | Particulate Matter | Nationwide |