A generic blood strain drug referred to as prazosin, made by Teva Prescription drugs, is being recalled by the Meals and Drug Administration as a result of it incorporates elevated ranges of cancer-causing chemical substances referred to as nitrosamines.

The recall, which Teva introduced on Oct. 7, 2025, impacts greater than 580,000 prazosin capsules. Prazosin is prescribed to round 510,000 sufferers yearly and is used to deal with post-traumatic stress dysfunction in addition to hypertension.

I’m a pharmacologist and pharmacist who has studied nitrosamine contamination of widespread blood strain, diabetes and heartburn medication, in addition to different points in generic drug manufacturing.

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Prazosin has been out there as a generic medicine for greater than 25 years and, like many generics which have been round that lengthy, is now produced by a number of producers.

This ratchets up competitors on value, which can clarify why older generics are extra liable to manufacturing points which will hurt affected person well being.

What are nitrosamines and the place do they arrive from?

Nitrosamines are by-products of many widespread chemical reactions. They kind when a sort of chemical constructing block referred to as a nitrite group interacts with one other kind referred to as an amine group.

Industrial processes like rocket gas, rubber and sealant manufacturing can produce excessive concentrations of nitrosamines throughout chemical reactions. Bacon, pepperoni and salami are excessive in nitrite preservatives that work together with the amine teams within the meats to kind small quantities of nitrosamines.

The chemical response that occurs when chlorinated water interacts with naturally occurring chemical substances that comprise nitrogen and oxygen can even kind small quantities of nitrosamines.

Occasional and small exposures to nitrosamines usually are not regarded as harmful. However some research have discovered that sure nitrosamines are carcinogenic when ingested in excessive quantities for lengthy intervals of time

European regulators first found in 2018 that pharmaceuticals may be contaminated when testing revealed that an energetic ingredient in a blood strain drug referred to as valsartan contained a nitrosamine chemical.

For the reason that Chinese language firm that made the drug’s energetic ingredient bought it to a number of producers of valsartan tablets, many corporations, together with Teva Prescription drugs, recalled the drug on the time.

The FDA then launched a serious effort to determine nitrosamines in prescription and over-the-counter medication and to outline unsafe ranges for tablets and capsules. It revealed an preliminary business steerage in 2021 and an up to date model in 2024.

Based mostly on the company’s new testing necessities, drugmakers have recognized nitrosamine contamination in broadly used blood strain, diabetes, heartburn, antibiotic and smoking cessation medication. A lot of the recalled medication have been contaminated throughout the chemical processing at a producing plant.

What ought to individuals who take prazosin do?

Teva Prescription drugs’ prazosin is only one of many generic variations – however it’s the one one that’s contaminated. You may decide whether or not your medicine got here from Teva by your prescription label. Seek for the abbreviations MFG or MFR, which stand for “manufacturing” or “producer.” If it says “MFG Teva” or “MFR Teva,” which means Teva Prescription drugs provided the medicine.

The primary 4 numbers of a Nationwide Drug Code, abbreviated as NDC on the prescription label, additionally reveal the producer or distributor. Teva merchandise have the quantity 0093.

If Teva Prescription drugs is the distributor, a pharmacist can cross-reference your prescription quantity to acquire the lot quantity and evaluate it with the posted lot numbers on the FDA web site for recalled prazosin. In case your product has been recalled, your pharmacy might produce other generic variations of prazosin in inventory that aren’t a part of this recall.

Based mostly on its threat evaluation for these tablets, the FDA gave the recall a Class II standing, which signifies that the medicine might trigger “momentary or medically reversible opposed well being penalties.”

If no different prazosin model exists at your pharmacy, don’t cease taking your drug with out speaking together with your doctor first. The chance of quickly taking tablets with an elevated quantity of nitrosamines could also be lower than the chance of immediately stopping this medicine.

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Your doctor can also have the ability to prescribe an various therapy akin to clonidine or trazodone.

Do older generics made abroad pose larger dangers?

Till lately, it wasn’t potential to match whether or not the protection information of generic medication manufactured abroad differed from the identical generics made within the U.S., as a result of the FDA doesn’t disclose which manufacturing crops corporations use to create their tablets and capsules. However in a 2025 research, researchers managed to triangulate that info from an FDA dataset.

They discovered that the chance of critical opposed occasions was 54.3% larger with generics made in India as in contrast with these made in the US. And the longer a drug has been out there in generic kind, the better the distinction in security threat between its U.S.- and India-made types.

As my colleague and I wrote in a commentary accompanying the research, the findings recommend that when the marketplace for generic medication is crowded by a number of producers, lower-priced choices naturally promote higher. Consequently, producers in growing nations are extra apt to supply poorer high quality merchandise which can be cheaper to supply.

Teva Prescription drugs has manufacturing crops all over the world, together with in India. The corporate has not disclosed the place its recalled prazosin capsules and their energetic and inactive elements have been manufactured.

The FDA publishes scores on generic drug high quality and claims that generics with an “A” ranking meet the identical manufacturing high quality requirements and obtain the identical blood concentrations as brand-name medication. However pharmacies cannot inform from these scores if a drug comes from manufacturing crops which can be at larger threat for high quality points.

Sufferers are on the mercy of selections pharmacies make within the generic variations of medication they procure for his or her shops. For my part, if pharmacies might entry dependable details about high quality, they could have the ability to make selections which can be safer for American shoppers.

C. Michael White, Distinguished Professor of Pharmacy Observe, College of Connecticut

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