Cefdinir Oral Suspension (Lupin) – Superpotent Drug Result (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
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
Brand
Lupin Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lot # F802189, Exp 10/2020, F900240, Exp 1/2021
Products Sold
Lot # F802189, Exp 10/2020, F900240, Exp 1/2021
Lupin Pharmaceuticals Inc. is recalling Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: due to Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.. 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
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
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