CLASS II Drug recall · Reported 19 Oct 2016 · FDA Enforcement Report

Amikacin Sulfate Injection, USP, 500 mg/ (250 mg/mL) recalled

Teva Pharmaceuticals USA 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

Lot, batch or date codesLot # 7080315, 7400315, 7410315, 7980415

Quantity recalled27,547 vials

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 USA, 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

Nationwide Puerto Rico

Questions about this recall

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 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 74816

Reported	Class	Recall	Company	Reason	Where
19 Oct 2016	CLASS II	Amikacin Sulfate Injection, USP, 1 gm/ (250 mg/mL) recalled	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Teva Pharmaceuticals USA

All 280

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29 Apr 2026Drug	CLASS II	Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
15 Apr 2026Drug	CLASS II	Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin	Teva Pharmaceuticals USA	Potency & Assay	4 states
15 Apr 2026Drug	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
22 Feb 2023Drug	CLASS II	Amikacin 450MG IN NS, Antibiotic, used in a Homepump recalled	Sentara Infusion Services	Sterility	Nationwide
25 Aug 2021Drug	CLASS II	Amikacin Sulfate Injection USP (250mg/ML) single-dose vials recalled	Teva Pharmaceuticals USA	Sterility	Nationwide
19 Jun 2019Drug	CLASS I	Amikacin Sulfate Injection, USP (250 mg/ml) vial recalledAmikacin Sulfate	Heritage Pharmaceuticals	Sterility	Nationwide
19 Oct 2016Drug	CLASS II	Amikacin Sulfate Injection, USP, 1 gm/ (250 mg/mL) recalled	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	Nationwide
1 Jun 2016Drug	CLASS I	Amikacin Sulfate injection USP,1 gm/ (250 mg/mL) vial recalled	Teva Pharmaceuticals USA	Particulate Matter	Nationwide