CLASS III Drug recall · Reported 13 Nov 2019 · FDA Enforcement Report

Cefdinir for Oral Suspension USP, 125 mg recalled

Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension USP, 125 mg, distributed nationwide in the US. The recall was initiated on 1 Nov 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20

NDC68180-722, 68180-723

UPC0368180723042

Quantity recalleda) 4074 bottles b) 30,300 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-0306-2020
FDA event ID: 84196
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Brand: Cefdinir
Manufacturer: Lupin Pharmaceuticals, Inc.
Classification: Class III
Status: Terminated
Recall initiated: 1 Nov 2019
FDA classified: 7 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Antibiotics

Timeline

1 Nov 2019	Recall initiated by company
7 Nov 2019	Classified by FDA	+6 days
13 Nov 2019	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

Presence of Foreign substance: identified as a dead ant.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA

Where it was distributed

Product was distributed to major distributors/wholesalers throughout the United States.

Nationwide

Questions about this recall

Why was it recalled?

Presence of Foreign substance: identified as a dead ant.

Which lots are affected?

Lot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20

Where was it sold?

Product was distributed to major distributors/wholesalers throughout the United States.

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

2 other products · FDA event 84196

This product is part of a recall event; the main page for the event is Cefdinir for Oral Suspension USP, 250 mg recalled.

Reported	Class	Recall	Company	Reason	Where
13 Nov 2019	CLASS III	Cefdinir for Oral Suspension USP, 250 mg recalledCefdinir	Lupin Pharmaceuticals	Other	Nationwide
13 Nov 2019	CLASS III	Cephalexin for Oral Suspension USP, 250 mg recalled	Lupin Pharmaceuticals	Other	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
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, 250 mg recalledCefdinir	Lupin Pharmaceuticals	Other	Nationwide