Recall archive / FDA company announcement

Pfizer: Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg — FDA announcement Apr 22, 2022

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Apr 22, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg
Reason: Due to N-Nitroso-Quinapril Content
Classification: Not supplied
Recalling firm: Pfizer
Quantity: Not supplied
Agency-reported status: Terminated in FDA listing
Source record identifier: 477f4de31f266499

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.; 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; Contact Center \| Contact Information \| Area of Support; Pfizer Medical Information \| 800-438-1985, option 3 (Mon.- Fri. 8 am-9 pm ET) www.pfizermedinfo.com \| For medical questions regarding the product; Pfizer Drug Safety \| 800-438-1985, option 1 (24 hours a day; 7 days a \| To report adverse events and product

Label field

Details supplied by the agency

Lot, code or applicability

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.; 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; Contact Center | Contact Information | Area of Support; Pfizer Medical Information | 800-438-1985, option 3 (Mon.- Fri. 8 am-9 pm ET) www.pfizermedinfo.com | For medical questions regarding the product; Pfizer Drug Safety | 800-438-1985, option 1 (24 hours a day; 7 days a | To report adverse events and product

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
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
0071-0532-23	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
0071-0535-23	CK6260	2022 MAY 31	40 mg	1 x 90 count bottle

FDA company announcement, table 2
Contact Center	Contact Information	Area of Support
Pfizer Medical Information	800-438-1985, option 3 (Mon.- Fri. 8 am-9 pm ET) www.pfizermedinfo.com	For medical questions regarding the product
Pfizer Drug Safety	800-438-1985, option 1 (24 hours a day; 7 days a	To report adverse events and product

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Fda listing date: Apr 22, 2022
Company announcement date: Apr 22, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What to do next

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the affected product and promptly contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am - 5:00 pm ET) to obtain a Business Reply Form (BRF) to initiate the return process. If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Sedgwick. Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you and then follow the instructions above for returning the product to Sedgwick. To request replacement product for any Pfizer PAP or Pfizer IPAP product you return, please contact 833-203-2776 (Mon.-Fri. 8 am-6 pm ET). Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the affected product should contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am - 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

Read the current instructions