Suprax Cefixime (Lupin) – Color Specification Issue (2013)
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
Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.
Brand
Lupin Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lot #s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014
Products Sold
Lot #s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014
Lupin Pharmaceuticals Inc. is recalling Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufact due to Discoloration; Product may not meet specifications for color description once reconstituted.. 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
Discoloration; Product may not meet specifications for color description once reconstituted.
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