Lower risk Drug recall · FDA · Published December 21, 2020

Merck Zerbaxa 1.5g Injection Vials: Sterility Risk in Some Batches

Merck recalls Zerbaxa 1.5g injection vials due to sterility test failures in some batches. Five batches tested positive for Ralstonia pickettii. Affected lots include SP1488 through SP1633 with expiry dates up to April 2023.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0176-2021Drug Merck ›

Lower-risk recall

Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.

Take action

Contact the company

Recalling firmMerck Sharp & Dohme126 E Lincoln Ave · Rahway, NJ 07065-4607

✎ GovInfoNow plain-language explainer

Merck is recalling certain Zerbaxa 1.5g injection vials because sterility tests on some batches showed contamination with Ralstonia pickettii bacteria. This could lead to infections if the medication is used improperly. Patients prescribed this drug should check their vial lot numbers and contact their healthcare provider if they have an affected batch. Read more at govinfonow.com/recall/36571-merck-zerbaxa-1-5g-injection-vials-sterility-risk-in-some.

Source Summary by GovInfoNow · govinfonow.com/recall/36571-merck-zerbaxa-1-5g-injection-vials-sterility-risk-in-some · Updated October 4, 2026 · FDA enforcement record: FDA #D-0176-2021

Cite this page

“Merck Zerbaxa 1.5g Injection Vials: Sterility Risk in Some Batches.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36571-merck-zerbaxa-1-5g-injection-vials-sterility-risk-in-some. Based on FDA recall #D-0176-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0176-2021%22&limit=1).

The FDA announced on Dec. 21, 2020, that Merck Sharp & Dohme is recalling Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection due to a lack of assurance of sterility. The recall affects 106,503 vials distributed nationwide.

How to tell if you have it

Brand: Merck
Product: Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial
NDC: 67919-030-01
Lots: SP1488 through SP1633 (all lots within expiry dates from June 2021 to April 2023)

The hazard

The results of sterility tests for seven batches were out of specification, with five testing positive for Ralstonia pickettii and two producing turbid results. Although all distributed product met registered specifications for release, it was manufactured on the same equipment as the affected batches.

Context

GovInfoNow's records show Merck has been involved in other recent recalls of similar products, including the Reliance Bortezomib Injection Recall for lack of sterility risk (2026-06-24) and the Reliance Pemetrexed Injection Recall for sterility risk in IV doses (2026-06-24).

How to tell if you have this one

Check the vial lot number on the label, which ranges from SP1488 to SP1633. The product was sold between June 2021 and April 2023 with expiration dates up to April 2023.

Brand
Merck
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Vial Lot Number
Look for the lot number on the vial label, which should be between SP1488 and SP1633.
Contact Healthcare Provider
If you have an affected lot number, contact your healthcare provider for instructions on next steps.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “U.S.A. 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 years after the firm started it.

Dec 21, 2020Firm started the recall
Jan 7, 2021FDA classified it Class II
Jan 13, 2021Published in FDA’s Enforcement Report
Dec 4, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/36571-merck-zerbaxa-1-5g-injection-vials-sterility-risk-in-some">Merck Zerbaxa 1.5g Injection Vials: Sterility Risk in Some Batches (GovInfoNow)</a>

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-0176-2021 (December 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0176-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 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.