CLASS II Drug recall · Reported 1 Jun 2016 · FDA Enforcement Report
Linezolid Injection, 600 mg/ Single use container bags recalled
Teva North America is recalling Linezolid Injection, 600 mg/ Single use container bags (, distributed nationwide in the US. The recall was initiated on 27 Apr 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-0868-2016
- FDA event ID
- 74180
- Recalling firm
- Teva North America, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Apr 2016
- FDA classified
- 24 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 27 Apr 2016 | Recall initiated by company | |
| 24 May 2016 | Classified by FDA | +27 days |
| 1 Jun 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Due to potential for leaking bags.
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
Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Due to potential for leaking bags.
Which lots are affected?
Lot # 2520715, Exp Date: 7/17
Where was it sold?
Nationwide
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.
More recalls from Teva North America
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Claravis (isotretinoin capsules USP), 10mg recalled | Teva North America | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Injection USP 40 mg/ (2 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Eptifibatide Injection 75 mg/ (0.75 mg/mL) single use vial recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Linezolid Injection 600 mg recalled by Teva North America | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
Other Linezolid recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Linezolid Injection 600 mg recalled by AuroMedics PharmaLinezolid | AuroMedics Pharma | Mold | Nationwide |
| Drug | CLASS I | Linezolid Injection 600 mg/ (2 mg/mL) Single-use recalledLinezolid | AuroMedics Pharma | Mold | NJ |
| Drug | CLASS II | Linezolid Injection 600 mg recalled by Teva North America | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |