AuroMedics Levofloxacin IV Recall: Leaking Bags Risk Mold Contamination
AuroMedics Pharma recalls specific lots of IV levofloxacin injections due to leaking bags and mold growth between outer packaging and overwrap. Stop using affected products immediately.
Stop using this now
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
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What happened, in plain English
AuroMedics Pharma recalled certain lots of IV levofloxacin injections because they were found leaking and mold grew between the outer bag and overwrap. This poses a risk of contamination during medical use. Read more at govinfonow.com/recall/40716-auromedics-levofloxacin-iv-recall-leaking-bags-risk-mold-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/40716-auromedics-levofloxacin-iv-recall-leaking-bags-risk-mold-contamination · Updated October 7, 2026 · FDA enforcement record: FDA #D-0709-2018
Cite this page
“AuroMedics Levofloxacin IV Recall: Leaking Bags Risk Mold Contamination.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40716-auromedics-levofloxacin-iv-recall-leaking-bags-risk-mold-contamination. Based on FDA recall #D-0709-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0709-2018%22&limit=1).
Why it’s dangerous
The medication bags leak, allowing mold to grow between the outer bag and the overwrap. This contamination could lead to serious infections if the medication is used improperly.
Who’s affected
Healthcare professionals using the recalled IV medication for intravenous infusion. Patients receiving treatment with these specific lots are at risk of contamination.
How to tell if you have this one
Check the product label for the NDC number 55150-245-52 and lot numbers like CLF160012 through CLF170052. The product was sold between 2018 and 2019.
- Brand
AuroMedics- Category
Drug
All 7 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
US Nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0703-2018 | Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51; Lot/Batch #'s: CLZ160001, CLZ160002, CLZ160003, CLZ160004 exp July 2018; CLZ160005, CLZ160006, CLZ160008, CLZ160009, CLZ160010 and CLZ160012, exp August 2018; CLZ160013, CLZ160014, CLZ160015, CLZ160016, exp October 2018; CLZ160017, CLZ160018, CLZ160019, CLZ160021, CLZ160022, CLZ160023, exp November 2018; CLZ170001, CLZ170002, CLZ170003, CLZ170004, CLZ170005, CLZ170006, exp March 2019; CLZ170007, CLZ170008, CLZ170009, CLZ170010, exp May 2019; CLZ170011, CLZ170012, exp June 2019; CLZ170013, CLZ170014, CLZ170015, CLZ170016, exp, September 2019; CLZ170017, exp October 2019 | 395150 bags | 55150-242-51 |
| D-0704-2018 | Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for: AuroMedics Pharma, LLC, NDC 55150-243-46.; Lot/Batch #'s: CLF160002, CLF160004, CLF160005 exp May 2018; CLF160006, CLF160007 exp June 2018; CLF170027 exp July 2019; CLF170029 exp August 2019 | 46824 bags | 55150-243-46, 55150-244-47, 55150-245-52 |
| D-0705-2018 | Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47.; Lot/Batch #'s: CLV160016, CLV160017, and CLV160018, exp Sept 2018, CLV160019, exp Oct 2018, CLV160020, CLV160021, and CLV160031, exp Nov 2018; CLV160032 and CLV170001, exp 12/18; CLV170008 and CLV170009, exp April 2019, CLV170020, CLV170021 and CLV170022, exp Oct 2019 | 261250 bags | 55150-246-47, 55150-247-47, 55150-248-47 |
| D-0706-2018 | Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47.; Lot/Batch #'s: CLV160013, CLV160014 and CLV160015, exp Sept 2018; CLV160022, CLV160023, CLV160024, CLV160025, CLV160026, CLV160027, CLV160028, CLV160029, CLV160030 exp Oct 2018; CLV170002, Dec 2018; CLV170010, exp April 2019; CLV170027, CLV170028, CLV170029 and CLV170030 exp Oct 2019 | 188941 bags | 55150-246-47, 55150-247-47, 55150-248-47 |
| D-0707-2018 | Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47.; Lot/Batch #'s: CLV160004, CLV160005, and CLV160006 exp September 2018; CLV170011, CLV170015, CLV170016 exp June 2019 | 67300 bags | 55150-246-47, 55150-247-47, 55150-248-47 |
| D-0708-2018 | Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-47; Lot/Batch #'s: CLF160008, CLF160009, CLF160010, CLF160011, exp June 2018; CLF160015, CLF160016 , CLF160017, exp August 2018; CLF170001 exp December 2018; CLF170023, CLF170024, exp May 2019; CLF170039, CLF170040, CLF170041, CLF170042, CLF170043, CLF170044, CLF170045, CLF170046, CLF170047 exp August 2019 | 308472 bags | 55150-243-46, 55150-244-47, 55150-245-52 |
| D-0709-2018 | Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52; Lot/Batch #'s: CLF160012, CLF160014 exp July 2018; CLF170007, CLF170008, CLF170009, CLF170010, CLF170011, CLF170012, CLF170013 exp February 2019; CLF170014, CLF170015, CLF170016 exp March 2019; CLF170017, CLF170018, CLF170019, exp April 2019; CLF170020, CLF170021, CLF170022 exp May 2019; CLF170035, CLF170036, CLF170037, CLF170038 exp August 2019; CLF170048, CLF170049, CLF170050, CLF170051, CLF170052 exp September 2019 | 308112 bags | 55150-243-46, 55150-244-47, 55150-245-52 |
What to do — step by step
Stop Using Immediately
Discard the recalled IV medication if you have it. Do not use the product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.9 years 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.
Questions people ask
What specific lots are affected?
Affected lots include CLF160012, CLF160014 (expiring July 2018) through CLF170052 (expiring September 2019).
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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-0709-2018 (March 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0709-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.