Zerbaxa Injection (Merck) – Sterility Concern (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01
Brand
Merck Sharp & Dohme
Lot Codes / Batch Numbers
All lots within expiry: SP1488 08-Jun-21, SP1490 11-Jun-21, SP1492 13-Jun-21, SP1493 15-Jun-21, SP1494 21-Jun-21, SP1495 23-Jun-21, SP1496 25-Jun-21, SP1497 27-Jun-21, SP1498 29-Jun-21, SP1509 20-Sep-21, SP1510 26-Sep-21, SP1515 16-Oct-21, SP1517 23-Oct-21, SP1518 25-Oct-21, SP1519 30-Oct-21, SP1520 01-Nov-21, SP1521 06-Nov-21, SP1522 08-Nov-21, SP1523, 13-Nov-21, SP1524, 15-Nov-21, SP1525 20-Nov-21, SP1526 27-Nov-21, SP1537 11-Jan-22, SP1564 17-Oct-22, SP1567 16-Oct-22, SP1572 24-Oct-22, SP1573, 28-Oct-22, SP1574 29-Oct-22, SP1584, 14-Nov-22, SP1586, 15-Nov-22, SP1588, 19-Nov-22, SP1593 03-Dec-22, SP1602 18-Dec-22, SP1603, 19-Dec-22, SP1606 08-Jan-23, SP1609 15-Jan-23, SP1610 20-Jan-23, SP1611 22-Jan-23, SP1626 13-Apr-23, SP1629 17-Apr-23, SP1633 21-Apr-23
Products Sold
All lots within expiry: SP1488 08-Jun-21; SP1490 11-Jun-21; SP1492 13-Jun-21; SP1493 15-Jun-21; SP1494 21-Jun-21; SP1495 23-Jun-21; SP1496 25-Jun-21; SP1497 27-Jun-21; SP1498 29-Jun-21; SP1509 20-Sep-21; SP1510 26-Sep-21; SP1515 16-Oct-21; SP1517 23-Oct-21; SP1518 25-Oct-21; SP1519 30-Oct-21; SP1520 01-Nov-21; SP1521 06-Nov-21; SP1522 08-Nov-21; SP1523;13-Nov-21; SP1524; 15-Nov-21; SP1525 20-Nov-21; SP1526 27-Nov-21; SP1537 11-Jan-22; SP1564 17-Oct-22; SP1567 16-Oct-22; SP1572 24-Oct-22; SP1573; 28-Oct-22; SP1574 29-Oct-22; SP1584; 14-Nov-22; SP1586; 15-Nov-22; SP1588; 19-Nov-22; SP1593 03-Dec-22; SP1602 18-Dec-22; SP1603; 19-Dec-22; SP1606 08-Jan-23; SP1609 15-Jan-23; SP1610 20-Jan-23; SP1611 22-Jan-23; SP1626 13-Apr-23; SP1629 17-Apr-23; SP1633 21-Apr-23
Merck Sharp & Dohme is recalling Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. due to Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested pos. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026