Teva Recalls Amikacin Sulfate Injection Due to CGMP Deviations
Teva Pharmaceuticals recalls specific lots of Amikacin Sulfate Injection due to Current Good Manufacturing Practice deviations. Check your lot numbers immediately.
Recall notice
CGMP Deviations
Contact the company
What happened, in plain English
Teva Pharmaceuticals USA is recalling Amikacin Sulfate Injection, USP, 500 mg/2 mL due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 27,547 vials distributed nationwide and in Puerto Rico. No specific injury mechanism or remedy details are provided in the record. Read more at govinfonow.com/recall/42510-teva-recalls-amikacin-sulfate-injection-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/42510-teva-recalls-amikacin-sulfate-injection-due-to-cgmp-deviations · Updated October 11, 2026 · FDA enforcement record: FDA #D-0023-2017
Cite this page
“Teva Recalls Amikacin Sulfate Injection Due to CGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42510-teva-recalls-amikacin-sulfate-injection-due-to-cgmp-deviations. Based on FDA recall #D-0023-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0023-2017%22&limit=1).
Why it’s dangerous
The recall is due to CGMP deviations, which indicate potential failures in the manufacturing process. The specific nature of these deviations and how they could impact product safety or efficacy is not described in the provided record.
Who’s affected
Patients prescribed Amikacin Sulfate Injection by healthcare providers may be affected. The record does not specify which patients are at risk or what symptoms to watch for.
How to tell if you have this one
Check if you have Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) manufactured in Hungary for Teva Pharmaceuticals USA. Look for NDC numbers 0703-9032-01 or 0703-9032-03 and Lot numbers 7080315, 7400315, 7410315, or 7980415.
- Brand
Teva 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 II- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0023-2017 | 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).; Lot # 7080315, 7400315, 7410315, 7980415 | 27,547 vials |
| D-0024-2017 | Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).; Lot # 2381114, 2771114, 4760915 | 11,844 vials |
What to do — step by step
Contact Healthcare Provider
Consult your doctor or pharmacist regarding the status of your medication and next steps.
Verify Lot Numbers
Check the vial labels against the recalled lot numbers: 7080315, 7400315, 7410315, and 7980415.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0023-2017 (July 29, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0023-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.