Key takeaways:
In March and April 2022, the manufacturer of quinapril (Accupril) and quinapril/hydrochlorothiazide (Accuretic) recalled several lots of both medications due to the presence of a potentially harmful chemical.
If you take quinapril or quinapril/hydrochlorothiazide, your pharmacist can help you find out if your product was affected by the recall. Don’t stop taking your quinapril medication without talking to your healthcare provider first.
If your quinapril product was affected by the recall, you may be able to switch to a quinapril product that isn’t recalled. Or your healthcare provider may prescribe a new medication altogether.
Over 133 million U.S. adults need medication to help lower their blood pressure. One common group of blood pressure medications is angiotensin-converting enzyme (ACE) inhibitors . ACE inhibitors include medications like lisinopril (Zestril), benazepril (Lotensin), and quinapril (Accupril).
But in March and April 2022, the manufacturer of quinapril and quinapril/hydrochlorothiazide (Accuretic) recalled several lots (or batches) of both medications due to high levels of potentially hazardous chemicals, called nitrosamines.
Here, we’ll cover everything you need to know about the quinapril recall — why it happened, which lots are recalled, and what to do if you have a recalled product.
Quinapril is a medication that treats high blood pressure. It is also used with diuretics (water pills) and/or digoxin (Lanoxin) to treat heart failure. Quinapril is usually taken once daily for high blood pressure and twice a day for heart failure.
Quinapril works by blocking ACE. Under normal circumstances, ACE helps make a chemical called angiotensin II. Angiotensin II is responsible for constricting blood vessels, which can raise your blood pressure. By blocking the activity of ACE, quinapril stops the production of angiotensin II and blood vessels can relax, which lowers your blood pressure.
Quinapril and quinapril/hydrochlorothiazide were recalled due to the presence of nitrosamines. Nitrosamines are chemicals that naturally exist in our food and water. When you encounter them, it’s usually in low amounts. If you ingest high amounts of nitrosamines, it can be dangerous and may raise your risk of cancer. This is why high levels of nitrosamines in medications can lead to recalls.
The specific nitrosamine found in some quinapril products is called Nnitroso-quinapril. During safety testing, it was discovered that certain batches (lots) of quinapril and quinapril/hydrochlorothiazide had higher levels of Nnitroso-quinapril than the acceptable intake limit. The acceptable intake limit is the amount of nitrosamines allowed in a medication. It’s decided by the FDA and other international agencies.
According to Pfizer, several lots of quinapril and quinapril/hydrochlorothiazide were affected by the recall. To see if your medication came from one of these lots, you can check the lot number on your bottle of medication. It’s typically printed on the side of each medication bottle.
You can also find the National Drug Code (or NDC). The NDC is a unique 10-digit number that helps the FDA identify a medication.
Only the lots mentioned below are affected by the recall as of June 2022. To stay up to date on medication recalls, you can check out the FDA list of drug recalls. If you take a quinapril product, you can also ask your pharmacist to check if it’s been affected by the recall. When a medication is recalled, your local pharmacy typically receives a notification letting them know.
Lot Number |
Strength |
NDC |
Expiration Date |
DR9639 |
10 mg |
0071-0530-23 |
March 2023 |
DX8682 |
20 mg |
0071-0532-23 |
March 2023 |
DG1188 |
20 mg |
0071-0532-23 |
May 2022 |
DX6031 |
40 mg |
0071-0535-23 |
March 2023 |
CK6260 |
40 mg |
0071-0535-23 |
May 2022 |
Lot Number |
Strength |
NDC |
Expiration Date |
FG5379 |
10 mg/12.5 mg |
0071-3112-23 |
August 2024 |
EA6686 |
10 mg/12.5 mg |
0071-0222-23 |
April 2022 |
FG5381 |
20 mg/12.5 mg |
0071-5212-23 |
August 2024 |
EA6665 |
20 mg/12.5 mg |
0071-0220-23 |
April 2022 |
CN0640 |
20 mg/12.5 mg |
0071-0220-23 |
April 2022 |
ET6974 |
20 mg/25 mg |
0071-0223-23 |
February 2023 |
Lot Number |
Strength |
NDC |
Expiration Date |
FE3714 |
20 mg/25 mg |
59762-5225-9 |
February 2023 |
DP3414 |
20 mg/25 mg |
59762-0223-1 |
February 2023 |
DN6931 |
20 mg/12.5 mg |
59762-0220-1 |
March 2023 |
ED3904 |
20 mg/12.5 mg |
59762-0220-1 |
March 2023 |
ED3905 |
20 mg/12.5 mg |
59762-0220-1 |
March 2023 |
If your medication has been affected by the recall, don’t stop taking it without talking to your healthcare provider first. Stopping quinapril suddenly can raise your blood pressure. This can raise your risk of having a heart attack or stroke.
If you’ve been taking a recalled quinapril product, your healthcare provider may still want you to continue taking it. But it should be from a lot that wasn’t affected by the recall. Or your healthcare provider may decide to prescribe you another medication to replace quinapril.
Other ACE inhibitors are going to be the most similar medication option to quinapril. There are several medications in this group, including:
Your healthcare provider may also decide to switch you to another class of medications entirely. A group of medications called angiotensin II receptor blockers (ARBs) are most similar to ACE inhibitors. They’re also used to treat high blood pressure and heart failure. Often, ACE inhibitors and ARBs can be used interchangeably.
It’s possible. For more information about how to return quinapril or quinapril/hydrochlorothiazide and get reimbursed, contact Sedgwick at 1-888-345-0481, Monday through Friday from 8AM to 5PM (ET).
There’s probably no immediate risk to someone that recently took a recalled quinapril product. But, we don’t know the effects of long-term use of recalled quinapril products.
Continuing to take recalled quinapril products isn’t recommended. It’s better to switch to a quinapril product that wasn’t recalled or another blood pressure medication entirely. But remember to talk to your healthcare provider before stopping your medication, even if it’s been recalled.
In March and April 2022, the manufacturers of quinapril and quinapril/hydrochlorothiazide announced a drug recall on several batches of the medications due to high levels of nitrosamines. Quinapril is a medication that’s used to treat high blood pressure and heart failure.
If you take quinapril or quinapril/hydrochlorothiazide, you’ll want to check if your specific product has been recalled. The pharmacy where you picked up your medication can help you find out. If your product has been recalled, talk to your healthcare provider about what to do next. They may switch you to a quinapril product that wasn’t affected by the recall, or switch you to a new medication altogether. But, don’t stop taking your medication before speaking with your provider first.
Bryant Ranch Prepack. (2022). Quinapril tablets [package insert].
Food and Drug Administration. (2022). Drug recalls.
Food and Drug Administration. (2021). Information about nitrosamine impurities in medications.
Food and Drug Administration. (2022). National drug code directory.
Food and Drug Administration. (2021). Control of nitrosamine impurities in human drugs: Guidance for industry.
Food and Drug Administration. (2022). Pfizer voluntary nationwide recall of lots of Accupril (quinapril HCL) due to n-nitroso-quinapril content.
Food and Drug Administration. (2022). Pfizer voluntary nationwide recall of lots of Accuretic (quinapril/hydrochlorothiazide), quinapril and hydrochlorothiazide tablets, and quinapril HCL/ hydrochlorothiazide tablets due to n-nitroso-quinapril content.
Ritchey, M. D., et al. (2018). Potential need for expanded pharmacologic treatment and lifestyle modification services under the 2017 ACC/AHA hypertension guideline. American Journal of Hypertension.
Vega, I. L., et al. (2015). ACE inhibitors vs. ARBs for primary hypertension. American Academy of Family Physicians.
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