Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Cefdinir Oral Suspension Recalled for Foreign Material

Agency Publication Date: May 14, 2024

Summary

Lupin Pharmaceuticals Inc. has voluntarily recalled 34,110 bottles of Cefdinir for Oral Suspension USP in 125 mg/5 mL and 250 mg/5 mL strengths. This recall was initiated following a product complaint regarding foreign material found in a bottle after it was mixed with water. Cefdinir is a prescription antibiotic used to treat various bacterial infections.

Risk

Ingesting foreign material in a liquid medication can cause physical injury to the mouth or digestive tract. Additionally, the presence of a foreign substance could potentially interfere with the effectiveness of the antibiotic treatment.

What You Should Do

This recall affects Cefdinir for Oral Suspension USP in 125 mg/5 mL and 250 mg/5 mL strengths, packaged in 60 mL bottles.
Identify if your product is affected by checking the lot number and NDC code on the label. Affected bottles include Lot F305292 with NDC 68180-722-04 (125 mg strength) and Lot F305442 with NDC 68180-723-04 (250 mg strength). Both lots have an expiration date of August 30, 2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL)

Variants: 250 mg/5 mL, Oral Suspension

Lot Numbers:

F305442 (Exp 8/30/2025)

NDC:

68180-723-04

Recall #: D-0496-2024; Quantity: 17,070 bottles

Product: Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL)

Variants: 125 mg/5 mL, Oral Suspension

Lot Numbers:

F305292 (Exp 8/30/2025)

NDC:

68180-722-04

Recall #: D-0497-2024; Quantity: 17,040 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94492

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: pharmacies

Manufactured In: United States, India

Units Affected: 2 products (17,070 bottles; 17,040 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Cefdinir for Oral Suspension USP in 125 mg/5 mL and 250 mg/5 mL strengths, packaged in 60 mL bottles.

Identify if your product is affected by checking the lot number and NDC code on the label. Affected bottles include Lot F305292 with NDC 68180-722-04 (125 mg strength) and Lot F305442 with NDC 68180-723-04 (250 mg strength). Both lots have an expiration date of August 30, 2025.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL)

Variants: 250 mg/5 mL, Oral Suspension

Lot Numbers:

F305442 (Exp 8/30/2025)

NDC:

68180-723-04

Recall #: D-0496-2024; Quantity: 17,070 bottles

Product: Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL)

Variants: 125 mg/5 mL, Oral Suspension

Lot Numbers:

F305292 (Exp 8/30/2025)

NDC:

68180-722-04

Recall #: D-0497-2024; Quantity: 17,040 bottles