CLASS I Drug recall · Reported 1 Jun 2016 · FDA Enforcement Report
Amikacin Sulfate injection USP,1 gm/ (250 mg/mL) vial recalled
Teva Pharmaceuticals USA is recalling Amikacin Sulfate injection USP,1 gm/ (250 mg/mL) vial, distributed nationwide in the US. The recall was initiated on 9 Mar 2016 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-0859-2016
- FDA event ID
- 73455
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 9 Mar 2016
- FDA classified
- 23 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 9 Mar 2016 | Recall initiated by company | |
| 23 May 2016 | Classified by FDA | +75 days |
| 1 Jun 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Product as listed by the FDA
Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Which lots are affected?
Lot #: 4750915, Exp 9/2017
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 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.
More recalls from Teva Pharmaceuticals USA
All 280| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
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 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 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 |