Pfizer has issued a voluntary nationwide recall of five (5) lots of Accupril (Quinapril HCl) tablets due to the presence of Nitroso-Quinapril. Pfizer distributed the affected products to the patient (consumer/user) level.
The recall was initiated after a recent testing revealed that the tablets contained nitrosamine, Nnitroso-quinapril which was above the Acceptable Daily Intake (ADI) level.
Everyone is exposed to a given level of nitrosamines from the environment and from food but are believed to be safe at the levels typically found in food.
However, high levels of nitrosamines can be carcinogenic and thus Pfizer initiated a voluntary recall out of an abundance of caution.
Accupril tablets are indicated for the treatment of hypertension and congestive heart failure. Accupril has maintained a safety profile established over 30 years. Pfizer has not received any reports of the adverse effects associated with the use of these products.
While long term ingestion of nitrosamine is associated with cancer risk in humans, patients taking these medications are not under any immediate risk.
Patients taking Accupril (Quinapril HCl) that have purchased the affected lots should discontinue use and immediately contact their healthcare provider or pharmacist to discuss alternate treatment options.
The affected product lots were distributed to wholesalers, distributors, and retailers throughout the United States and Puerto Rico from December 2019 to April 2022. The recalled products can be identified by lot numbers listed below:
- Accupril® (Quinapril HCl Tablets), 10 mg
- Accupril® (Quinapril HCl Tablets), 20 mg
- Accupril® (Quinapril HCl Tablets), 40 mg
| NDC | Lot Number | Expiration
Date |
Strength | Configuration/ Count |
| 0071-0530-23 | DR9639 | 2023 MAR 31 | 10 mg | 1 x 90 count bottle |
| 0071-0532-23 | DX8682 | 2023 MAR 31 | 20 mg | 1 x 90 count bottle |
| DG1188 | 2022 MAY 31 | 20 mg | 1 x 90 count bottle | |
| 0071-0535-23 | DX6031 | 2023 MAR 31 | 40 mg | 1 x 90 count bottle |
| CK6260 | 2022 MAY 31 | 40 mg | 1 x 90 count bottle |
Pfizer is sending letters to wholesalers, distributors, retailers, and healthcare professionals to return any of the recalled products. Wholesalers and distributors with the inventory of the affected products should stop the distribution and quarantine the products immediately.
Wholesalers and distributors who had distributed the products should notify their accounts about the recall information. They should stop the distribution immediately and contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am – 5:00 pm ET) to obtain a Business Reply Form (BRF) for the return process.
Patients should confirm with their healthcare providers or pharmacies to confirm if they have the recalled products before using them.
In case they have the recalled products, they should contact their healthcare providers or pharmacies for a replacement of another product with similar efficacy and safety profile. Patients are also advised to not dispose of the affected lots in household garbage.
Patients and caregivers with questions regarding this recall can contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am – 5:00 pm ET). Patients who experience any problems that may be linked to the use of the affected products should contact their healthcare professionals immediately.
Healthcare providers with questions regarding the recall can contact Pfizer through the following information:
- For medical questions regarding the product
Pfizer Medical Information: 800-438-1985, option 3 (Mon.- Fri. 8 am-9 pm ET) www.pfizermedinfo.com
- To report adverse events and product
Pfizer Drug Safety: 800-438-1985, option 1 (24 hours a day; 7 days a
Any adverse reactions or quality issues can be reported to FDA’s MedWatch Adverse Event Reporting program via their website at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
