READ. SCROLL. LISTEN.

Unbiased headlines. Facts, not spin.

Unbiased Headlines is an independently owned news organization. We bring you the facts, not opinions, written fresh from 110+ named sources. Sources linked so you can verify it yourself.

← Back to headlines

Three Blood Pressure Combination Drugs Made in India Recalled This Month, Plus a GNC Supplement With Hidden Drugs

Three Blood Pressure Combination Drugs Made in India Recalled This Month, Plus a GNC Supplement With Hidden Drugs
FDA recall postings this month cover amlodipine combination tablets from Ascend/Alkem, Macleods and Viatris, over failed dissolution tests and one superpotent ingredient, plus a male-enhancement supplement sold at GNC franchises that contained undeclared prescription drugs. The agency classes the blood pressure recalls as lower-risk, and its guidance is that patients generally keep taking their medicine unless told otherwise. Some Viatris lots expire Oct. 31, and the FDA has not said whether any further lots are affected.

Three blood pressure pill recalls and one supplement recall have surfaced in FDA postings and company announcements. The supplement, sold at GNC franchises, contained prescription erectile dysfunction drugs the label never mentioned.

None of the postings reports an injury. Here is what each one says.

Ascend and Alkem: 11,424 bottles

New Jersey-based Ascend Laboratories is recalling 11,424 bottles of amlodipine and olmesartan medoxomil tablets, 10 mg/40 mg, lot 25120696, expiring Dec. 31, 2026. The reason listed is "out of specification due to dissolution."

Alkem Laboratories Ltd., based in India, manufactured the tablets. Ascend distributed them nationwide. The Epoch Times, citing the FDA notice, reports that Alkem has had several medications recalled this year.

The recall began Oct. 6. The FDA classified it Oct. 16 as Class II and added it to its enforcement database for the week of Oct. 30. The notice does not say what consumers should do, and Ascend issued no news release.

Macleods: olmesartan, amlodipine and hydrochlorothiazide

In a separate action posted this week, Macleods Pharma USA, Inc. recalled olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in a 40 mg/10 mg/12.5 mg dose. Macleods Pharmaceuticals Ltd., also based in India, made the drug.

The listed reason is "Failed Dissolution Specifications." The recall covers 3,528 30-count bottles, lot 12251163A, expiring May 31, 2027, and 216 90-count bottles, lot 12251163B, with the same expiration date.

The recall was initiated Oct. 7, and the FDA classified it Class II on Oct. 26.

Viatris: 21,620 bottles, one ingredient too strong

Viatris, based in Morgantown, West Virginia, is recalling 21,620 bottles of telmisartan and amlodipine tablets, 40 mg/5 mg, in 30-count bottles. The FDA notice describes the problem as a "superpotent drug" and cites the "potential for the Telmisartan content in these lots to exceed specifications."

The tablets were made in India for Mylan Pharmaceuticals Inc. The affected lots are 3228113, 3228114 and 3228115, which expire Oct. 31, 2026, and 3228120 and 3228121, which expire Nov. 30, 2026. According to the notice, the recall was first issued Oct. 1 and carries the FDA's Class III designation, its lowest tier.

The FDA defines Class III as a situation where use of the product "is not likely to cause adverse health consequences." Some of these lots expire Oct. 31.

What the FDA tells patients

The agency does not want patients dropping their medication on their own. Under its published guidance, consumers can generally continue taking a Class II or III recalled drug unless the recalling company says otherwise.

"In some instances, stopping your medicine may be more harmful to your health than continuing to take the recalled medicine," the FDA says. It tells patients to talk to a doctor or pharmacist with questions.

Class II, the tier covering the Ascend and Macleods products, applies where exposure "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

A dissolution failure is an out-of-specification result, meaning the product fell outside the acceptance criteria set in its drug application. A superpotent tablet may carry more of one ingredient than specified.

The supplement: hidden Viagra and Cialis ingredients

Separately, Tonight We Ride, LLC of Lakeville, Minnesota announced on Oct. 24 that it is recalling all lots of Ultimate Forza Male Supplement capsules to the consumer level. The company said the product contains undeclared sildenafil, tadalafil and dapoxetine.

Sildenafil and tadalafil are the active ingredients in Viagra and Cialis. The announcement says they may interact with nitrates found in some prescription drugs, such as nitroglycerin, and "may lower blood pressure to dangerous levels." Dapoxetine is not approved by the FDA. It belongs to the SSRI class of drugs, and the announcement says consumption has been shown to increase the risk of suicidal thinking and behavior in children, adolescents and young adults.

The supplement was distributed through certain independently owned and operated GNC franchise locations from 2017 to Oct. 1, 2026, not through GNC corporate stores. The recall was initiated after GNC's third-party product testing identified the undeclared ingredients. Sales were stopped, affected products were quarantined at franchise locations, and customers were notified to discontinue use and return remaining product.

No adverse events or complaints have been reported. Consumers should stop using the product immediately and can return it to a GNC store for a full refund, providing a receipt or the phone number or email address tied to the loyalty account used for the purchase. Questions go to GNC Customer Service at 1-877-462-4700.

Open questions

All three blood pressure products trace to manufacturers in India. The FDA notices do not say what caused the dissolution failures or the superpotency, and the recalling companies have not explained.

The Forza product was distributed from 2017 until Oct. 1, 2026, before testing flagged it. The announcement does not say how many units were sold.

The next information to watch is whether the FDA widens any of these recalls to additional lots, and whether Ascend, Macleods or Viatris issue patient instructions beyond the agency's general guidance.

Sources used for this briefing

3 links from 3 independent newsrooms (syndicated copies of the same report count once)

These are the sources it draws on, linked so you can verify.

Gov
fdaTonight We Ride, LLC Issues Voluntary Recall of Ultimate Forza Male Supplement Due to Presence of Undeclared Sildenafil, Tadalafil, and Dapoxetine
right
Epoch TimesThousands of Bottles of Blood Pressure Drugs Recalled Across US - The Epoch Times
right
ExpressUrgent blood pressure drug recall issued over 'super potent' pills