Lupin Recalls 20 mg Lisinopril Tablets Due to Product Mix-Up
Lupin Pharmaceuticals is recalling 20 mg Lisinopril tablets because 10 mg tablets were found inside sealed 20 mg bottles.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a product mix-up (wrong dosage) rather than a high-risk pathogen or structural defect, fitting the Moderate criteria for labeling/packaging errors.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 11,808 bottles of Lisinopril Tablets USP, 20 mg, 1000-count. The recall is due to a product mix-up where 10 mg Lisinopril tablets were found inside two sealed bottles labeled as 20 mg.
The affected product is identified by Lot # Q000255 and an expiration date of 01/2022. The product was distributed nationwide in the United States.
Consumers should check their medication for this specific lot number and expiration date. If they have the affected product, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 11,808
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 # Q000255
- Exp 01/2022
Distribution
Distributed nationwide across the United States.
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