Drug FDA Class II Terminated cGMP deviation

Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04

Lupin Pharmaceuticals Inc. Published Jun 5, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Lupin Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Defective container: lack of seal integrity.

Hazards

Lack of Seal Integrity · primary

Affected products (1)

Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04

CEFDINIR · 51,006 bottles

NDC: 68180-722, 68180-723, 68180-722-20, 68180-722-10, 68180-722-04, 68180-722-05, 68180-723-20, 68180-723-10, 68180-723-04, 68180-723-05

Lot codes: F305184

Code info: Lot #F305184, F305185, F305186, Exp 7/31/ 2025

Affected areas

Nationwide

Timeline

Initiated

May 8, 2024
Published

Jun 5, 2024
Terminated

Apr 29, 2025

Recall number: D-0518-2024
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.