Novartis recalls one lot of Diovan (valsartan) — Class II, nationwide
- Novartis Pharmaceuticals recalled one lot of Diovan (its valsartan brand, used for high blood pressure, heart failure, and post-heart-attack left ventricular failure) due to a potency issue.
- Affected: 160 mg tablets, 90-count bottles, lot AV5913C, expiration June 2027.
- Manufactured by Patheon Manufacturing Services LLC in North Carolina, USA; distributed by Novartis.
- Reason: “failed dissolution specifications” — pills may not dissolve properly in the body.
- Initiated Aug. 4, 2026; FDA classified as Class II (temporary/reversible effects possible, low probability of serious harm).
- Bottle count not disclosed; recall is nationwide.
- Valsartan is an angiotensin II receptor blocker (relaxes blood vessels); ~10.9 million US patients took it in 2024.
- Unrelated to the 2018 valsartan recalls, which stemmed from carcinogenic contamination (NDMA) at Zhejiang Huahai Pharmaceuticals in Linhai, China.
Other recent heart/BP drug recalls noted in the article:
- Dabigatran etexilate (blood thinner) — recalled by Alkem Laboratories Ltd., manufactured in India; ~5,600 packages, over an impurity/degradation issue.
- Amlodipine and olmesartan medoxomil tablets — manufactured by Alkem Laboratories Ltd. (India), distributed by Ascend Laboratories LLC (New Jersey, USA); 6,192 bottles affected.
Pattern: the Diovan recall is the only one of the three current recalls tied to US-based manufacturing (North Carolina) — the other two originate from Indian manufacturing, and the 2018 precedent traces to Chinese manufacturing.