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

Ceftriaxone Sodium (Sterile) USP active pharmaceutical recalled

Lupin Pharmaceuticals is recalling Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931, 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 #: B4000935, Exp 01/17; B4005178, Exp 06/17; B4008730, B4008729, B4008727, B4008724, Exp 10/17; B5001647, B5001648, B5001649, Exp 02/18

Quantity recalled741.171 kg

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-0955-2016
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: active pharmaceutical ingredient intermediates failed specifications.

Product as listed by the FDA

Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.

Which lots are affected?

Lot #: B4000935, Exp 01/17; B4005178, Exp 06/17; B4008730, B4008729, B4008727, B4008724, Exp 10/17; B5001647, B5001648, B5001649, Exp 02/18

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 for Injection USP, 250 mg, Single Use Vial recalled	Lupin Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

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