The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0497-2024·Announced 2024-05-22

Antibiotic Cefdinir Oral Suspension Recalled Over Foreign Material

Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to foreign material found in reconstituted bottles. This FDA Class II recall affects 17,040 bottles distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves foreign material contamination in an antibiotic medication with potential to cause harm if ingested. No illnesses or injuries have been reported, making this a risk-of-harm scenario without documented injury, consistent with a High severity classification per the rubric.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling one lot of Cefdinir for Oral Suspension USP 125 mg/5 mL due to the discovery of foreign material in a reconstituted bottle. Cefdinir is an antibiotic used to treat bacterial infections.

The affected product is Lot # F305292 with an expiration date of 8/30/2025. The recall affects 17,040 bottles that were distributed nationwide throughout the United States.

Consumers who have this medication should stop using it immediately and contact their pharmacy or healthcare provider. The FDA has classified this as a Class II recall. Those with questions can contact Lupin Pharmaceuticals or the FDA.

The recalled product

Product
CEFDINIR (CEFDINIR)
Brand
CEFDINIR
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Oral Suspension
Hazard
Affected units
17,040

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # F305292
  • Exp 8/30/2025

UPCs (1)

  • 0368180723042

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Lupin Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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