Lupin Recalls Lisinopril Tablets Due to Foreign Tablet Presence
Lupin Pharmaceuticals is recalling specific bottles of 10 mg Lisinopril tablets because 20 mg tablets were found inside. Consumers should stop using the affected product.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II due to the presence of foreign tablets (20 mg in a 10 mg bottle), which poses a risk of incorrect dosing. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 11,688 bottles of Lisinopril Tablets USP, 10 mg, 1000 count. The recall was initiated because 20 mg Lisinopril tablets were found in a bottle labeled for 10 mg tablets. The affected product is identified by Lot # Q000232 and an expiration date of 01/2022.
The product was distributed to Ohio and may have been further distributed throughout the United States. The tablets are manufactured by Lupin Limited in Nagpur, India, for BluePoint Laboratories under NDC 68001-334-08.
Consumers who have this specific lot of Lisinopril should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- LISINOPRIL (LISINOPRIL)
- Brand
- LISINOPRIL
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 11,688
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 # Q000232
- exp. date 01/2022
UPCs (1)
- 0368001334082
Distribution
Distributed in 1 state:
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