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State Drug Alert: 111 Batches Including Paracetamol, Telmisartan Fail CDSCO Quality Tests

Written By : Susmita Roy   |  
State Drug Alert: CDSCO Flags 78 NSQ, Spurious, Misbranded Drug Samples in April Quality Checks
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New Delhi: Continuing its nationwide surveillance of drug quality, the Central Drugs Standard Control Organisation (CDSCO) has flagged 111 drug, cosmetic and medical device samples as Not of Standard Quality (NSQ), misbranded, spurious, or otherwise non-compliant with prescribed standards in its May 2026 drug alert, based on test reports submitted by State Drug Testing Laboratories across the country.

The alert covers a broad range of products, including antibiotics, antidiabetics, antihypertensives, analgesics, gastrointestinal medicines, respiratory formulations, cardiovascular drugs, vitamin supplements, injections, ointments, oral rehydration products, medical devices, hand sanitizers, and cosmetic products.

Several widely used medicines were found to have failed critical quality parameters such as assay, dissolution, disintegration, description, pH, content uniformity, microbial examination, identification tests, and labeling requirements. A number of products were also declared misbranded, while one antibiotic formulation was classified as spurious.

Among the notable products flagged by CDSCO are Rabeprazole sodium IP 40mg manufactured by Cadila pharmaceuticlas, Telmisartan Tablets IP 40 mg manufactured by Hindustan Laboratories, and Folic Acid Tablets IP. 0.4 mg manufactured by Unicure India, Chlorpheniramine Maleate Tablets IP 4mg manufactured by Medisky Pharmaceuticals; Telmikind Trio 12.5 manufactured by Synokem Lifesciences, Oxytocin Injection IP 5 IU/ml manufactured by Jackson Laboratories, Clopidogrel Tablets IP manufactured by Bactolac Formulations, Metformin Hydrochloride Prolonged Release Tablets IP 500mg manufactured by Carewell Steuart Pharma, Ondansetron Injection IP-2mg/ml manufactured by Marc Laboratories, and others.

Also Read:State Drug Alert: CDSCO Flags 78 NSQ, Spurious, Misbranded Drug Samples in April Quality Checks

The list further includes popular formulations such as Paracetamol and Domperidone Tablets (Dompar) manufactured by Cipla, Amoxycillin and Potassium Clavulanate Tablets IP manufactured by Sun Pharmaceuticals, Amoxycillin and Potassium Clavulanate Tablets IP manufactured by Alkem Health, and Cefixime Dispersible Tablets IP 200 mg manufactured by Skymap Pharmaceuticals.

A number of products were declared misbranded, including multiple batches of Aceclofenac-Paracetamol combinations, Cefixime and Ofloxacin tablets, Itraconazole Capsules, Lipstick products, and Vitamin preparations that failed statutory labeling requirements.

One batch of Amoxycillin and Potassium Clavulanate Tablets manufactured by Apex Formulation, Himachal Pradesh, was reported by Bihar Drug Control Laboratory as failing identification and content tests and was classified as spurious.

A batch of Cefixime Dispersible Tablets IP 200 mg manufactured by Skymap Pharmaceuticals Pvt. Ltd. was declared misbranded, while Lipstick manufactured by Kiss Love Cosmetics, Delhi, was also reported as misbranded.

The sunscreen lotion and facewash products were found to be non-compliant with microbial examination standards, raising concerns over product quality and consumer safety. The absorbent gauze sample failed to meet prescribed standards for length, width and weight.

The products were reported by drug testing laboratories from Jammu & Kashmir, West Bengal, Assam, Goa, Karnataka, Kerala, Maharashtra, Odisha, Punjab, Rajasthan, Tamil Nadu, Telangana, Tripura, Uttarakhand and other states.

Also Read:CDSCO Flags 46 Drug Batches Including Thyroxine, Amoxycillin-Clavulanate as NSQ in May 2026

Under the Drugs and Cosmetics Act, 1940, a drug is deemed "Not of Standard Quality" if it does not comply with the standards specified in the Indian Pharmacopoeia (IP) or other prescribed requirements. Such alerts are issued by CDSCO based on laboratory analyses conducted by central and state drug testing laboratories to safeguard public health and ensure compliance with regulatory standards.

Details of Products Reported in CDSCO's May 2026 Alert

cdscostate drug alertdrug alertstate drug testing laboratorynot of standard qualityamoxycillin clavulanateMetforminglimepiride
Susmita Roy
Susmita Roy

    Mpharm (Pharmacology)

    Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

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