CLASS II Drug recall · Reported 25 Apr 2018 · FDA Enforcement Report

Lupin Cefdinir powder for Oral Suspension USP, 250 mg recalled

Lupin Pharmaceuticals is recalling Lupin Cefdinir powder for Oral Suspension USP, 250 mg/ in (a) packs (, distributed nationwide in the US. The recall was initiated on 27 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # F602241; Exp. 10/18 Lot # F602577; Exp. 11/18 Lot # F700036; Exp. 12/18

NDC68180-722, 68180-723

UPC0368180723042

Quantity recalled40,824 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-0684-2018
FDA event ID: 79612
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Brand: Cefdinir
Manufacturer: Lupin Pharmaceuticals, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 27 Mar 2018
FDA classified: 17 Apr 2018
Reported: 25 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Antibiotics

Timeline

27 Mar 2018	Recall initiated by company
17 Apr 2018	Classified by FDA	+21 days
25 Apr 2018	Published in enforcement report	+8 days

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

Reason for recall

Superpotent Drug

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

Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Superpotent Drug

Which lots are affected?

Lot # F602241; Exp. 10/18 Lot # F602577; Exp. 11/18 Lot # F700036; Exp. 12/18

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

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Other Cefdinir recalls

All 11

Reported	Class	Recall	Company	Reason	Where
5 Jun 2024Drug	CLASS II	Cefdinir for Oral Suspension USP, 250 mg recalledCefdinir	Lupin Pharmaceuticals	Packaging Defects	Nationwide
22 May 2024Drug	CLASS II	Cefdinir for Oral Suspension USP 125 mg/ when reconstituted) recalledCefdinir	Lupin Pharmaceuticals	Foreign Material	Nationwide
22 May 2024Drug	CLASS II	Cefdinir for Oral Suspension USP 250 mg/ when reconstituted) recalledCefdinir	Lupin Pharmaceuticals	Foreign Material	Nationwide
29 Jul 2020Drug	CLASS II	Cefdinir for Oral Suspension USP, 250 mg recalledCefdinir	Lupin Pharmaceuticals	Potency & Assay	Nationwide
13 Nov 2019Drug	CLASS III	Cefdinir for Oral Suspension USP, 125 mg recalledCefdinir	Lupin Pharmaceuticals	Packaging Defects	Nationwide