Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted) Recalled by Lupin Pharmaceuticals Inc. Due to Foreign Object Contamination

Date: April 24, 2024
Company: Lupin Pharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Lupin Pharmaceuticals Inc. directly.

Affected Products

Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04

Quantity: 17,040 bottles

Why Was This Recalled?

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Lupin Pharmaceuticals Inc.

Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report