Ceftriaxone Injection 250mg (Lupin) – CGMP Deviation (2016)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
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
Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Brand
Lupin Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lot #: a) C500031, Exp 12/17, b) C500026, Exp 12/17, C500036, C500043, Exp 01/18
Products Sold
Lot #: a) C500031, Exp 12/17; b) C500026, Exp 12/17; C500036, C500043, Exp 01/18
Lupin Pharmaceuticals Inc. is recalling Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68 due to CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.. 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
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
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