Lisinopril Injection Recalled for Sterility Assurance Concerns
Olympia Pharmacy is recalling Lisinopril 20 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as sterility assurance failures in injectable medications.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one unit of Lisinopril 20 mg/ml Injection. The product was compounded by Olympia Pharmacy in Orlando, FL, and distributed nationwide and to Puerto Rico. The specific code for the recalled product is A5028 with an expiration date of 6/2/13.
The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used during compounding. Specifically, there is a lack of assurance of sterility for the product. The agency has classified this recall as Class II.
Consumers and healthcare providers who have this specific product should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Lisinopril 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1
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 (1)
- A5028 Exp 6/2/13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 105 recalled by Lowlite Investments, Inc. D/B/A Olympia Pharmacy 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.
See all 105 products in this recall →Related recalls
Same manufacturer · Lowlite Investments, Inc. D/B/A Olympia Pharmacy
See all →- SevereOlympia Pharmacy Recalls Diclazuril Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- HighOlympia Pharmacy Recalls Metabolase Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- SevereOlympia Pharmacy Recalls Oxytocin Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- SevereOlympia Pharmacy Recalls Betamethasone Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- SevereOlympia Pharmacy Recalls HACC 270.1 Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
Same hazard · sterility
See all →- SevereHouston Rx LLC Recalls Tirzepatide/Niacinamide Vials Due to Sterility Concerns
FDA (Drugs) · 2026-10-21
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighInjectable drug recalled for lack of sterility assurance
FDA (Drugs) · 2022-06-01
- HighCompounded Injectable Medication Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-06-01
- HighDexpanthenol 250 mg/mL Injectable Solution Recalled for Sterility Failure
FDA (Drugs) · 2022-06-01
- HighSermorelin Acetate Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-06-01
- HighLidocaine-Epinephrine Injectable Vials Recalled for Sterility Assurance Failure
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Phenylephrine 1 mg/mL Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-06-01