CLASS II Drug recall · Reported 22 May 2024 · FDA Enforcement Report

Cefdinir for Oral Suspension USP 250 mg/ when reconstituted) recalled

Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension USP 250 mg/ when reconstituted), distributed nationwide in the US. The recall was initiated on 24 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # F305442, Exp 8/30/2025

NDC68180-722, 68180-723

UPC0368180723042

Quantity recalled17,070 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-0496-2024
FDA event ID: 94492
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Brand: Cefdinir
Manufacturer: Lupin Pharmaceuticals, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2024
FDA classified: 14 May 2024
Reported: 22 May 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Drug class: Antibiotics

Timeline

24 Apr 2024	Recall initiated by company
14 May 2024	Classified by FDA	+20 days
22 May 2024	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

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04

Where it was distributed

USA nationwide

Nationwide

Questions about this recall

Why was it recalled?

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Which lots are affected?

Lot # F305442, Exp 8/30/2025

Where was it sold?

USA 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.

Other products in this recall event

1 other product · FDA event 94492

Reported	Class	Recall	Company	Reason	Where
22 May 2024	CLASS II	Cefdinir for Oral Suspension USP 125 mg/ when reconstituted) recalledCefdinir	Lupin Pharmaceuticals	Foreign Material	Nationwide

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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
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
13 Nov 2019Drug	CLASS III	Cefdinir for Oral Suspension USP, 250 mg recalledCefdinir	Lupin Pharmaceuticals	Other	Nationwide