Lupin Recalls Cephalexin Oral Suspension Due to Foreign Substance
Lupin Pharmaceuticals is recalling Cephalexin for Oral Suspension bottles because a dead ant was identified as a foreign substance.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard is a foreign substance (dead ant) with no reported injuries or illnesses.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottles. The recall was initiated because a foreign substance, identified as a dead ant, was found in the product.
The affected product is prescription-only and was distributed to major distributors and wholesalers throughout the United States. The specific lots involved are F802436, F802437, F802438, and F802442, all with an expiration date of 11/20. The total quantity recalled is 28,254 bottles.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or distributor for disposal or credit. Patients should contact their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- 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
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 28,254
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: F802436
- F802437
- F802438
- F802442
- Exp 11/20
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Lupin Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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