The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0496-2024·Announced 2024-05-22

Antibiotic Cefdinir Oral Suspension Recalled for Foreign Material Contamination

Lupin Pharmaceuticals is recalling Cefdinir Oral Suspension USP 250 mg/5 mL (Lot F305442, expiration 8/30/2025) due to foreign material found in reconstituted bottles. Approximately 17,070 bottles were 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 contamination from foreign material without reported illnesses or injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported qualify as High (Score 3).

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Cefdinir for Oral Suspension USP 250 mg/5 mL due to the presence of foreign material in reconstituted bottles. The affected lot is F305442 with an expiration date of 8/30/2025, and approximately 17,070 bottles were distributed nationwide.

The recall was initiated following product complaints of foreign material found in reconstituted bottles. Cefdinir is a prescription antibiotic used to treat bacterial infections.

Patients who have this medication should not use it and should contact their pharmacy or healthcare provider immediately. Do not discontinue your prescribed antibiotic without consulting your doctor, as you may need an alternative medication to continue treatment.

This is an FDA Class II recall. For more information, contact Lupin Pharmaceuticals Inc. or visit the FDA website.

The recalled product

Product
CEFDINIR (CEFDINIR)
Brand
CEFDINIR
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Oral Suspension / Antibiotic
Hazard
Affected units
17,070

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 # F305442
  • 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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