Regulators have announced separate recalls involving two prescription blood pressure medicines. One lot of Diovan 160 mg has been recalled in the United States, while Taiwan has ordered the withdrawal of 87,360 Beniel 8 mg tablets. Patients should check their medicine packaging and consult a healthcare professional before changing treatment.
Could a blood pressure tablet that does not dissolve as expected provide less medicine than the patient needs?
Separate batches of two hypertension medicines have been recalled in the United States and Taiwan after failing dissolution requirements. Although both recalls concern how the tablets dissolve, they involve different drugs, manufacturers, batches and regulatory authorities.
One Diovan Lot Recalled Across the United States
Novartis Pharmaceuticals voluntarily recalled one lot of Diovan, its brand of valsartan, after the tablets failed dissolution specifications. The US Food and Drug Administration classified the action as a Class II recall.
The affected medicine is Diovan 160 mg supplied in bottles containing 90 tablets. Patients and pharmacists should check for lot number AV5913C and an expiration date of June 2027. No additional Diovan lots were listed in the recall information.
The tablets were manufactured by Patheon Manufacturing Services in Greenville, North Carolina, and distributed by Novartis Pharmaceuticals Corporation.
Beniel Recall Affects Over 87,000 Tablets in Taiwan
Taiwan’s Food and Drug Administration ordered the recall of 87,360 Beniel F.C. Tablets 8 mg manufactured by Synmosa Biopharma Corporation.
The action applies only to batch 2KA31. Stability testing found that the tablets did not meet the required dissolution standard, potentially affecting their quality and effectiveness.(1✔ ✔Trusted Source
TFDA orders recall of over 87,000 antihypertensive tablets
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Synmosa was instructed to complete the recall by August 24 and submit an investigation and corrective-action report. Taiwanese authorities said other batches were not affected and sufficient supplies were available to prevent a shortage.
Dissolution Problems May Affect Drug Performance
A dissolution test measures how quickly and completely a tablet releases its active ingredient under controlled conditions. Passing this test helps demonstrate that the medicine should deliver the intended dose consistently.
A failure does not necessarily mean every tablet is ineffective. However, a tablet that dissolves too slowly or incompletely may release less medicine than expected, potentially reducing absorption and blood pressure control.
The recalls relate to drug performance rather than reports of contamination. Patients should identify whether their specific lot is affected instead of assuming that every package containing the same medicine has been recalled.
Diovan and Beniel Lower Blood Pressure Differently
Diovan contains valsartan, an angiotensin II receptor blocker. It reduces the blood vessel-tightening effects of angiotensin II, allowing vessels to relax and blood pressure to fall. Valsartan is also prescribed for certain patients with heart failure or following a heart attack.(2✔ ✔Trusted Source
Valsartan
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Beniel contains benidipine hydrochloride, a long-acting calcium channel blocker. It lowers blood pressure by reducing calcium movement into blood vessel muscle cells, helping the vessels relax and improving blood flow.
Because the medicines belong to different drug classes, patients should not substitute one for the other without medical advice.
FDA Class II Recall Indicates Moderate Risk
The FDA defines a Class II recall as one in which exposure to a product may cause temporary or medically reversible health consequences, or where the possibility of serious harm is remote.
This classification does not mean the recall should be ignored. Inadequately controlled blood pressure may increase cardiovascular risk, particularly among people also being treated for heart failure or complications following a heart attack.
How To Identify the Recalled Blood Pressure Tablets
People taking Diovan 160 mg in the United States should check the lot number and expiration date on the bottle. Those using Beniel 8 mg in Taiwan should look for batch number 2KA31.
Patients who cannot locate the information should take the package to their pharmacist. Pharmacies and healthcare facilities should follow the recall instructions and remove affected stock from circulation.(1✔ ✔Trusted Source
TFDA orders recall of over 87,000 antihypertensive tablets
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Consult a Doctor Before Changing Blood Pressure Treatment
Patients should not abruptly stop taking prescribed blood pressure medicine or switch to another product on their own. The FDA advises that patients affected by many Class II recalls may continue treatment unless instructed otherwise by the regulator, manufacturer or healthcare professional.
Anyone who has an affected batch should contact their pharmacist or prescribing doctor promptly for instructions about replacement medicine. Valsartan users are specifically advised not to stop treatment without consulting their doctor.
Medical attention should be sought urgently if a patient experiences chest pain, severe breathlessness, fainting, sudden weakness or other symptoms suggesting a cardiovascular emergency.
Recalls Reinforce the Need for Quality Monitoring
The two actions demonstrate why stability and dissolution testing continue after medicines reach the market. Tablets can appear normal while failing laboratory standards that assess whether they release their active ingredients reliably throughout their shelf life.
Prompt recalls, clear batch identification and access to replacement medicine can reduce disruption while protecting patients who depend on uninterrupted hypertension treatment.
References:
- TFDA orders recall of over 87,000 antihypertensive tablets- (https://focustaiwan.tw/society/202608120010)
- Valsartan- (https://medlineplus.gov/druginfo/meds/a697015.html)
Source-Medindia