CLASS III Drug recall · Reported 9 Apr 2014 · FDA Enforcement Report

Suprax, Cefixime for Oral Suspension USP 500 mg recalled

Lupin Pharmaceuticals is recalling Suprax, Cefixime for Oral Suspension USP 500 mg/ (when reconstituted), distributed nationwide in the US. The recall was initiated on 27 Jan 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #s: F300737 Exp. February 2015, F300743 Exp. February 2015

Quantity recalled4,038 bottles

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-1186-2014
FDA event ID: 67462
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Classification: Class III
Status: Terminated
Recall initiated: 27 Jan 2014
FDA classified: 2 Apr 2014
Reported: 9 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

27 Jan 2014	Recall initiated by company
2 Apr 2014	Classified by FDA	+65 days
9 Apr 2014	Published in enforcement report	+7 days

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

Reason for recall

Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.

Which lots are affected?

Lot #s: F300737 Exp. February 2015, F300743 Exp. February 2015

Where was it sold?

Nationwide

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

1 other product · FDA event 67462

This product is part of a recall event; the main page for the event is Suprax, Cefixime for Oral Suspension USP, 500 mg recalled.

Reported	Class	Recall	Company	Reason	Where
9 Apr 2014	CLASS III	Suprax, Cefixime for Oral Suspension USP, 500 mg recalled	Lupin Pharmaceuticals	Potency & Assay	Nationwide

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Reported	Class	Recall	Company	Reason	Where
9 Apr 2014Drug	CLASS III	Suprax, Cefixime for Oral Suspension USP, 500 mg recalled	Lupin Pharmaceuticals	Potency & Assay	Nationwide