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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Antibiotic Oral Suspensions Recalled for Dead Ant Contamination

Agency Publication Date: November 7, 2019
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Summary

Lupin Pharmaceuticals Inc. has voluntarily recalled 62,844 bottles of Cephalexin and Cefdinir oral suspension antibiotics due to the discovery of a dead ant inside the product. These prescription medications are used to treat bacterial infections in children and adults. The recall affects specific batches of these liquid medications distributed to wholesalers and distributors across the United States. Consumers should check their medicine cabinets for the specific lot numbers and bottle sizes listed to ensure their medication is safe to use.

Risk

The presence of a foreign substance, specifically a dead ant, in a liquid oral medication poses a risk of contamination and potential physical harm or allergic reaction if ingested. While the risk level is classified as low, foreign matter in pharmaceutical products indicates a potential breach in quality control during manufacturing.

What You Should Do

  1. Check your prescription bottle for the following specific products and lot numbers: Cephalexin for Oral Suspension USP 250 mg/5mL (Lot F802436, F802437, F802438, F802442), Cefdinir for Oral Suspension USP 250 mg/5mL (Lot F802345, F802346, F802347), and Cefdinir for Oral Suspension USP 125 mg/5mL (Lot F900153, F802327, F802328, F802329).
  2. Verify the expiration date on the bottle is November 2020 (Exp 11/20).
  3. If your medication matches these lot numbers, contact your healthcare provider or pharmacist immediately to obtain guidance on continuing your treatment and to secure a replacement prescription.
  4. Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund.
  5. Contact Lupin Pharmaceuticals Inc. at their Baltimore headquarters for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return to pharmacy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Cephalexin for Oral Suspension USP, 250 mg/5mL (200 mL bottle)
Model:
NDC 68180-0441-02
Recall #: D-0304-2020
Lot Numbers:
F802436 (Exp 11/20)
F802437 (Exp 11/20)
F802438 (Exp 11/20)
F802442 (Exp 11/20)
Date Ranges: Expiration 11/20
Product: Cefdinir for Oral Suspension USP, 250 mg/5mL (100 mL bottle)
Model:
NDC 68180-723-10
Recall #: D-0305-2020
Lot Numbers:
F802345 (Exp 11/20)
F802346 (Exp 11/20)
F802347 (Exp 11/20)
Date Ranges: Expiration 11/20
Product: Cefdinir for Oral Suspension USP, 125 mg/5mL (60 mL bottle)
Model:
NDC 68180-722-20
Recall #: D-0306-2020
Lot Numbers:
F900153 (Exp 11/20)
Date Ranges: Expiration 11/20
Product: Cefdinir for Oral Suspension USP, 125 mg/5mL (100 mL bottle)
Model:
NDC 68180-722-10
Recall #: D-0306-2020
Lot Numbers:
F802327 (Exp 11/20)
F802328 (Exp 11/20)
F802329 (Exp 11/20)
Date Ranges: Expiration 11/20

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84196
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: distributors; wholesalers
Manufactured In: India, United States
Units Affected: 3 products (28,254 bottles; 30,516 bottles; a) 4074 bottles b) 30,300 bottles)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.