Lower risk Drug recall · FDA · Published November 1, 2019

Lupin Cefdinir Oral Suspension Recall: Dead Ant Found in Product

Lupin Pharmaceuticals recalls 250mg/5mL Cefdinir oral suspension bottles due to dead ant contamination. This recall affects specific lots manufactured in Baltimore, Maryland. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0305-2020Drug Lupin Pharmaceuticals ›

Lower-risk recall

Presence of Foreign substance: identified as a dead ant.

Take action

Contact the company

Recalling firmLupin Pharmaceuticals Inc.Harborplace Tower, 111 S Calvert St Fl 21st · Baltimore, MD 21202-6174

✎ GovInfoNow plain-language explainer

Lupin Pharmaceuticals is recalling Cefdinir oral suspension bottles that contain a dead ant. This contamination poses a potential risk of ingestion of foreign material, which could cause health issues for users. Read more at govinfonow.com/recall/37769-lupin-cefdinir-oral-suspension-recall-dead-ant-found-in-product.

Source Summary by GovInfoNow · govinfonow.com/recall/37769-lupin-cefdinir-oral-suspension-recall-dead-ant-found-in-product · Updated October 5, 2026 · FDA enforcement record: FDA #D-0305-2020

Cite this page

“Lupin Cefdinir Oral Suspension Recall: Dead Ant Found in Product.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37769-lupin-cefdinir-oral-suspension-recall-dead-ant-found-in-product. Based on FDA recall #D-0305-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0305-2020%22&limit=1).

The FDA announced on November 1, 2019, that Lupin Pharmaceuticals Inc. voluntarily recalled Cefdinir for Oral Suspension USP due to the presence of a dead ant. The agency classified this Class III recall as terminated.

How to tell if you have it

Brand: Lupin Pharmaceuticals
Product: Cefdinir for Oral Suspension USP, 250 mg/5mL, 100 mL bottle
NDC: 68180-723-10
Lot codes: F802345, F802346, F802347
Expiration date: 11/20
Quantity: 30,516 bottles

The hazard

The recall addresses the presence of a foreign substance identified as a dead ant within the medication bottles. The FDA classified this issue as a Class III hazard.

Context

GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since January 31, 2013. Recent brand recalls include a Clobetasol Cream recall for failed content uniformity specifications on August 3, 2026, and a Glucagon Emergency Kit recall citing CGMP deviation risk on June 23, 2026. Other recent recalls of similar products include Zep Alcohol Sanitizer Spray Recall (May 22, 2026), Guardian Drug CAREone Calcium Antacid Recall (May 28, 2026), and Guardian Drug Family Wellness Antacid Tablets Recall (May 28, 2026).

How to tell if you have this one

Check for the product name 'Cefdinir for Oral Suspension USP', 250 mg/5mL, 100 mL bottle, Rx only. Look for lot numbers F802345, F802346, or F802347 with expiration date 11/20.

Brand
Lupin Pharmaceuticals
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Terminated
Distribution
Product was distributed to major distributors/wholesalers throughout the United States.

Recall number	Product, codes & lots	Quantity	NDC
D-0304-2020	Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02; Lot #: F802436, F802437, F802438, F802442, Exp 11/20	28,254 bottles	—
D-0305-2020	Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10; Lot #: F802345, F802346, F802347, Exp 11/20	30,516 bottles	68180-722-20, 68180-722-10, 68180-722-04, 68180-722-05, 68180-723-20, 68180-723-10, 68180-723-04, 68180-723-05
D-0306-2020	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; Lot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20	a) 4074 bottles b) 30,300 bottles	68180-722-20, 68180-722-10, 68180-722-04, 68180-722-05, 68180-723-20, 68180-723-10, 68180-723-04, 68180-723-05

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name, lot number, and expiration date to confirm if it's part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Product was distributed to major distributors/wholesalers throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 16 months after the firm started it.

Nov 1, 2019Firm started the recall
Nov 7, 2019FDA classified it Class III
Nov 13, 2019Published in FDA’s Enforcement Report
Mar 4, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/37769-lupin-cefdinir-oral-suspension-recall-dead-ant-found-in-product">Lupin Cefdinir Oral Suspension Recall: Dead Ant Found in Product (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0305-2020 (November 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0305-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.