Cefdinir for Oral Suspension USP
Defective container: lack of seal integrity.
Most common reason: Particulate / foreign matter (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cefdinir. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Defective container: lack of seal integrity.
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Presence of Foreign substance: identified as a dead ant.
Presence of Foreign substance: identified as a dead ant.
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Superpotent Drug
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
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