FDA Orders Recall of Rs 2.45 Crore Worth of Medicines Over Similar Brand Names That Could Cause Medication Errors
Pune, 12th July 2026: The Maharashtra Food and Drug Administration (FDA) has ordered the immediate recall of medicines worth nearly ₹2.45 crore manufactured by a multinational pharmaceutical company after finding that the branding of newly launched products could lead to medication errors and pose a potential risk to public health.
The action has been initiated against Cadila Pharmaceuticals, which markets anti-acidity medicines under the well-known Aciloc brand.
According to the FDA, the company had approval to manufacture and sell Aciloc 150 and Aciloc 300, which contain Ranitidine as the active pharmaceutical ingredient and are used to treat acidity, heartburn and stomach ulcers.
However, the company subsequently introduced Aciloc 150 Plus and Aciloc 300 Plus, containing Famotidine, a different acid-suppressing drug. Although both medicines are prescribed for similar medical conditions, they contain different active ingredients and dosages.
The FDA said the similarity in brand names, combined with nearly identical packaging and label artwork, could result in doctors, pharmacists or patients mistakenly prescribing, dispensing or consuming the wrong medicine.
The issue came to light during a routine inspection conducted by the FDA in Amravati. Investigators found that the company had launched the new “Plus” variants by merely adding a “+” symbol to the established brand name while retaining similar packaging, despite the medicines containing an entirely different active ingredient.
Officials noted that the simultaneous availability of both the old and new products in the market significantly increased the risk of confusion among healthcare professionals and patients.
Following the investigation, the FDA conducted raids at the company’s carrying and forwarding agent (CFA) warehouses in Pune, Nagpur and Bhiwandi (Thane district).
Under the guidance of FDA Commissioner Tukaram Mundhe, the department prohibited the distribution of medicine stocks worth:
- ₹89.45 lakh in Pune,
- ₹98.71 lakh in Nagpur, and
- ₹57.20 lakh in Bhiwandi.
The total value of the recalled stock is approximately ₹2.45 crore.
Ganesh Rokade, Joint Commissioner (Drugs), FDA, said that confusion arising from similar medicine names is a serious public health concern.
“Confusion caused by medicine brand names is a serious issue for public health. Pharmaceutical companies must strictly comply with regulatory norms while selecting brand names and marketing medicines. Safe medicines are a fundamental right of citizens. Further legal action is being initiated under the Drugs and Cosmetics Act, 1940,” Rokade said.
The FDA has directed the company to immediately recall the affected medicines from the market while legal proceedings under the Drugs and Cosmetics Act, 1940 are underway.
