Ceftriaxone Injection (Aidarex) – manufacturing 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, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Brand
Aidarex Pharmaceuticals LLC
Lot Codes / Batch Numbers
Lot#: 47312-1, Exp 01/2018
Products Sold
Lot#: 47312-1, Exp 01/2018
Aidarex Pharmaceuticals LLC is recalling CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Ph due to CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.. 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: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
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 noticeDistribution
As reported by FDA
GA, IN
Page updated: Jan 7, 2026