CLASS I Drug recall · Reported 16 Jan 2019 · FDA Enforcement Report

Ceftriaxone for Injection recalled by Lupin Pharmaceuticals

Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, distributed nationwide in the US. The recall was initiated on 20 Dec 2018 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: C600109, Exp 05/19; C600129, C600135, Exp 08/19

Quantity recalled3,792 boxes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0358-2019
FDA event ID: 81796
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Classification: Class I
Status: Terminated
Recall initiated: 20 Dec 2018
FDA classified: 14 Jan 2019
Reported: 16 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Antibiotics

Timeline

20 Dec 2018	Recall initiated by company
14 Jan 2019	Classified by FDA	+25 days
16 Jan 2019	Published in enforcement report	+2 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.

Where it was distributed

Nationwide in the USA and Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Is Ceftriaxone for Injection USP recalled?

Yes. Lupin Pharmaceuticals recalled Ceftriaxone for Injection USP on 20 Dec 2018. The recall is Class I and its status is Terminated. Recall number D-0358-2019.

Why was it recalled?

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

Which lots are affected?

Lot #: C600109, Exp 05/19; C600129, C600135, Exp 08/19

Where was it sold?

Nationwide in the USA and Puerto Rico.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Lupin Pharmaceuticals

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Other Ceftriaxone recalls

All 21

Reported	Class	Recall	Company	Reason	Where
24 May 2023Drug	CLASS II	Ceftriaxone for Injection, USP per Pharmacy recalled	Astral SteriTech Private	Sterility	Nationwide
24 May 2023Drug	CLASS II	Ceftriaxone for Injection, USP per vial recalled	Astral SteriTech Private	Sterility	Nationwide
24 May 2023Drug	CLASS II	Ceftriaxone for Injection, USP 250 mg per vial recalled	Astral SteriTech Private	Sterility	Nationwide
24 May 2023Drug	CLASS II	Ceftriaxone for Injection, USP per vial recalled	Astral SteriTech Private	Sterility	Nationwide
24 May 2023Drug	CLASS II	Ceftriaxone for Injection, USP per vial recalled	Astral SteriTech Private	Sterility	Nationwide