Lupin Recalls Lisinopril 5 mg Tablets Due to Product Mix-Up
Lupin Pharmaceuticals is recalling 4,224 bottles of Lisinopril 5 mg tablets because 10 mg tablets were found in the 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 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, and the hazard involves a product mix-up that could lead to incorrect dosing of a prescription medication, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 4,224 bottles of Lisinopril 5 mg tablets, USP, 1000-count. The recall is due to a product mix-up where Lisinopril 10 mg tablets were found in the 5 mg bottles.
The affected product is identified by Lot # Q900683 and an expiration date of 10/31/2022. The bottles were distributed nationwide within the US.
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 on obtaining a replacement.
The recalled product
- Product
- LISINOPRIL (LISINOPRIL)
- Brand
- LISINOPRIL
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 4,224
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 # Q900683
- Exp. 10/31/2022
UPCs (3)
- 0368180513018
- 0368180512028
- 0368180513032
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LISINOPRIL
- HighLisinopril 10 mg Tablets Recalled for Metal Fragment Contamination
FDA (Drugs) · 2024-11-27
- HighLisinopril Tablets Recalled for Embedded Metal Contamination
FDA (Drugs) · 2022-09-21
- HighLupin Recalls Lisinopril Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2020-08-05
- ModerateLupin Recalls Lisinopril Tablets Due to Foreign Tablet Mix-Up
FDA (Drugs) · 2020-04-08
- SevereLupin Recalls Lisinopril Tablets Due to Metal Contaminant
FDA (Drugs) · 2018-08-22
Same manufacturer · Lupin Pharmaceuticals Inc.
See all →- ModerateLupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
FDA (Drugs) · 2026-09-02
- SevereGlucagon Emergency Kit Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2026-07-08
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- ModerateGanirelix acetate injection recalled after failing an impurity specification
FDA (Drugs) · 2025-12-17
Same hazard · product mix up
See all →- HighAripiprazole 30mg bottle contained voriconazole 50mg tablets instead
FDA (Drugs) · 2026-06-24
- HighLisinopril and hydrochlorothiazide bottle contained a foreign antiretroviral tablet
FDA (Drugs) · 2025-07-23
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- HighKWIK-STICK Quality Control Kit for Culture Media Swab Mix-Up
FDA (Devices) · 2025-06-18
- HighStryker 3.0MM Neuro Precision Head Recalled for Package Labeling Mismatch
FDA (Devices) · 2025-01-29
Similar recalls
- ModerateLupin Recalls Lisinopril Tablets Due to Foreign Tablet Mix-Up
FDA (Drugs) · 2020-04-08
- ModerateLupin Recalls 20 mg Lisinopril Tablets Due to Product Mix-Up
FDA (Drugs) · 2020-04-29
- LowLupin Recalls Lisinopril Tablets Due to CGMP Deviations
FDA (Drugs) · 2016-09-28
- HighLupin Recalls Lisinopril Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2020-08-05
- SevereLupin Recalls Lisinopril Tablets Due to Metal Contaminant
FDA (Drugs) · 2018-08-22
- ModerateLupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to CGMP Deviations
FDA (Drugs) · 2016-07-06