The Central Drugs Standard Control Organization (CDSCO), in its September 2026 Not of Standard Quality (NSQ) alert, has listed multiple batches of Eli Lilly’s Mounjaro KwikPen against reported assay, sterility and related-substances testing failures.
The listed batches include:
2.5 mg/0.6 mL: Batch D924668 — failed assay and sterility tests.
5 mg/0.6 mL: Batch D928027 — failed assay, sterility and related-substances/impurities tests.
7.5 mg/0.6 mL: Batch D938368 — failed assay test.
12.5 mg/0.6 mL: Batch D894806 — failed assay test.
15 mg/0.6 mL: Batch D949932 — failed assay test.
The alert identifies Eli Lilly Italy S.p.A. as the manufacturer and Eli Lilly and Company (India) Pvt. Ltd. as the importer. The 10 mg/0.6 mL presentation, batch D949702, is also listed, with the entry stating that the sample did not test for assay and related substances/impurities.
The same September alert lists other products with quality failures. These include Telma Beta 50 (telmisartan and metoprolol succinate extended-release tablets), batch GLB26001, manufactured by Glenmark Pharmaceuticals Ltd., for telmisartan content; and Levera-500 (levetiracetam 500 mg tablets), batch N2601077, manufactured by Intas Pharmaceuticals Ltd., for dissolution and labelling-related deficiencies.
Separately, the alert classifies Urja Urbpro capsules, batch URJA702, as spurious after testing detected tadalafil at 8.67 mg per capsule. Faiza Beauty Cream, batch 23FBC24, was also declared spurious after testing identified hydroquinone, with a reported content of 0.76 mg/g.
The findings are relevant to pharmacists, hospital procurement teams, distributors and quality-assurance professionals reviewing affected batches and supply-chain records.
