CLASS III Drug recall · Reported 8 Jun 2016 · FDA Enforcement Report

Ceftriaxone for Injection USP, 250 mg, Single Use Vial recalled

Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 250 mg, Single Use Vial, distributed nationwide in the US. The recall was initiated on 11 Mar 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: a) C500031, Exp 12/17; b) C500026, Exp 12/17; C500036, C500043, Exp 01/18

Quantity recalled15408 vials

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-0951-2016
FDA event ID: 73830
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Classification: Class III
Status: Terminated
Recall initiated: 11 Mar 2016
FDA classified: 2 Jun 2016
Reported: 8 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Manufacturing (CGMP) Deviations
Drug class: Antibiotics

Timeline

11 Mar 2016	Recall initiated by company
2 Jun 2016	Classified by FDA	+83 days
8 Jun 2016	Published in enforcement report	+6 days

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

Reason for recall

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Product as listed by the FDA

Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count 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.

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Which lots are affected?

Lot #: a) C500031, Exp 12/17; b) C500026, Exp 12/17; C500036, C500043, Exp 01/18

Where was it sold?

Nationwide 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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 73830

This product is part of a recall event; the main page for the event is Ceftriaxone for Injection USP, Single Use Vial recalled.

Reported	Class	Recall	Company	Reason	Where
8 Jun 2016	CLASS III	Ceftriaxone for Injection USP, Single Use Vial recalled	Lupin Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
8 Jun 2016	CLASS III	Ceftriaxone for Injection USP, 500 mg, Single Use Vial recalled	Lupin Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
8 Jun 2016	CLASS III	Ceftriaxone for Injection USP, Single Use Vial recalled	Lupin Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
8 Jun 2016	CLASS III	Ceftriaxone Sodium (Sterile) USP active pharmaceutical recalled	Lupin Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Lupin Pharmaceuticals

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Other Ceftriaxone recalls

All 22

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