Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Ceftriaxone for Injection USP Recalled by Lupin Pharmaceuticals Inc. Due to Presence of Particulate Matter: Product complaints received of...

Date: December 20, 2018
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

Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

Quantity: a) 12,000 vials; b) 11,763 boxes

Why Was This Recalled?

Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

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