CLASS II Drug recall · Reported 29 Jul 2020 · FDA Enforcement Report

Cefdinir for Oral Suspension USP, 250 mg recalled

Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension USP, 250 mg, distributed nationwide in the US. The recall was initiated on 2 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # F802189, Exp 10/2020, F900240, Exp 1/2021

NDC68180-722, 68180-723

UPC0368180723042

Quantity recalled35,928 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-1406-2020
FDA event ID: 85960
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Brand: Cefdinir
Manufacturer: Lupin Pharmaceuticals, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 2 Jul 2020
FDA classified: 23 Jul 2020
Reported: 29 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Antibiotics

Timeline

2 Jul 2020	Recall initiated by company
23 Jul 2020	Classified by FDA	+21 days
29 Jul 2020	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

Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.

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

Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20

Where it was distributed

U.S.A. Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.

Which lots are affected?

Lot # F802189, Exp 10/2020, F900240, Exp 1/2021

Where was it sold?

U.S.A. 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
13 Nov 2019Drug	CLASS III	Cefdinir for Oral Suspension USP, 125 mg recalledCefdinir	Lupin Pharmaceuticals	Packaging Defects	Nationwide
13 Nov 2019Drug	CLASS III	Cefdinir for Oral Suspension USP, 250 mg recalledCefdinir	Lupin Pharmaceuticals	Other	Nationwide