CLASS II Drug recall · Reported 19 Oct 2016 · FDA Enforcement Report
Amikacin Sulfate Injection, USP, 500 mg/ (250 mg/mL) recalled
Teva Pharmaceuticals U is recalling Amikacin Sulfate Injection, USP, 500 mg/ (250 mg/mL), distributed nationwide in the US. The recall was initiated on 29 Jul 2016 and the FDA has classified it as Class II.
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-0023-2017
- FDA event ID
- 74816
- Recalling firm
- Teva Pharmaceuticals U, North Wales, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2016
- FDA classified
- 12 Oct 2016
- Reported
- 19 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Jul 2016 | Recall initiated by company | |
| 12 Oct 2016 | Classified by FDA | +75 days |
| 19 Oct 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Amikacin Sulfate Injection, USP, 500 mg/ (250 mg/mL) recalled?
Yes. Teva Pharmaceuticals U recalled Amikacin Sulfate Injection, USP, 500 mg/ (250 mg/mL) on 29 Jul 2016. The recall is Class II and its status is Terminated. Recall number D-0023-2017.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # 7080315, 7400315, 7410315, 7980415
Where was it sold?
Nationwide and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Amikacin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amikacin Sulfate Injection USP (250mg/ML) single-dose vials recalled | Teva Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS I | Amikacin Sulfate Injection, USP (250 mg/ml) vial recalledAmikacin Sulfate | Heritage Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Amikacin Sulfate Injection, USP, 1 gm/ (250 mg/mL) recalled | Teva Pharmaceuticals U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Amikacin Sulfate injection USP,1 gm/ (250 mg/mL) vial recalled | Teva Pharmaceuticals U | Particulate Matter | Nationwide |
| Drug | CLASS II | Amikacin Injection, all strengths and all presentations including recalled | FVS Holdings | Sterility | Nationwide |