Lupin Recalls Cephalexin Oral Suspension Due to Missing Manufacturing Records
Lupin Pharmaceuticals is recalling 7,215 bottles of Cephalexin for Oral Suspension because the manufacturing batch record could not be located.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a CGMP deviation (missing batch record) without reported illnesses or injuries, fitting the rubric for moderate severity involving documentation issues or low-risk contamination.
Plain-English summary
Lupin Pharmaceuticals Inc. is voluntarily recalling 7,215 bottles of Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only. The product is identified by NDC 68180-0124-02, lot number F602820, and an expiration date of December 2019. The recall was initiated because the manufacturing batch record for this specific lot could not be located, representing a Current Good Manufacturing Practice (CGMP) deviation.
The affected product was distributed to 12 major distributors, who may have further distributed the medication throughout the United States. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 7,215
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 (2)
- lot # F602820
- Expiry December 2019
Distribution
Distribution scope not specified by the agency.
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