The FDA announced on May 8, 2024, that Lupin Pharmaceuticals Inc. voluntarily recalled Cefdinir for Oral Suspension USP due to defective containers lacking seal integrity. The recall affects 51,006 bottles distributed nationwide.
How to tell if you have it
- Brand: Lupin
- Product: Cefdinir for Oral Suspension USP, 250 mg/5 mL
- Packaging: 60 mL bottle
- NDC: 68180-723-04
- Lot codes: F305184, F305185, F305186
- Expiration date: 7/31/ 2025
The hazard
The recall was initiated because the product containers lack seal integrity. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since 2013-01-31. Recent brand recalls include the Lupin Clobetasol Cream Recall on 2026-08-03 for failed content uniformity, the Lupin Glucagon Emergency Kit Recall on 2026-06-23 for CGMP deviation risk, and the Lupin prednisolone acetate ophthalmic suspension recall on 2026-06-04 for a foreign substance. Other recent recalls of similar products include the Keystone Burkhart Anesthetic Gel Recall (2026-05-21), the Keystone DHP Topical Anesthetic Gel Recall (2026-05-21), and the Keystone Safco SensiCaine-Ultra Gel Recall (2026-05-21).