Mumbai: The Maharashtra Food and Drug Administration (FDA) has directed the recall of four medicines manufactured by Cadila Pharmaceuticals Ltd., citing concerns that similar brand names for products containing different active pharmaceutical ingredients could lead to medication errors.
The regulator has also prohibited the sale and distribution of two of the products and seized medicine stocks worth approximately Rs 2.45 crore across the state as part of its enforcement action.
Four Aciloc products under recall
The FDA’s order applies to the following products:
- Aciloc 150
- Aciloc 150 Plus
- Aciloc 300
- Aciloc 300 Plus
Officials said the medicines contain two different active ingredients—Ranitidine and Famotidine—despite having similar brand names.
The regulator has instructed the company to immediately recall all available stocks of the four products from the market.
In addition, the sale and distribution of Aciloc 150 Plus and Aciloc 300 Plus have been barred.
Concern over medication errors
According to the Maharashtra FDA, the similarity in branding could result in doctors, pharmacists or patients inadvertently selecting the wrong medicine.
Although both Ranitidine and Famotidine belong to the H2 receptor blocker class of medicines and are commonly prescribed to treat acid reflux and related gastric conditions, they are different drugs with distinct chemical compositions and dosage requirements.
Health regulators have previously cautioned that medicines with nearly identical brand names but different formulations or strengths can increase the risk of dispensing or consuming the wrong product, particularly when packaging appears similar.
FDA cites public health risk
Maharashtra FDA Commissioner Tukaram Mundhe said the possibility of confusion arising from similar branding poses a serious public health concern.
He emphasised that compliance with regulations governing the branding, labelling and marketing of medicines is essential to ensure patient safety and minimise the risk of medication errors.
The regulator said preventing confusion between medicines remains a key aspect of pharmaceutical oversight.
Stock worth Rs 2.45 crore seized
As part of the enforcement action, the Maharashtra FDA seized stocks of the affected medicines worth around Rs 2.45 crore from various locations across the state.
Officials said the action forms part of the department’s routine surveillance of medicines available in the market.
The FDA regularly conducts inspections of pharmaceutical manufacturers, distributors and retail outlets to identify labelling violations, quality issues and other regulatory non-compliance.
Further action under review
The Maharashtra FDA said additional action against the company will depend on its compliance with the recall order and the findings of the ongoing regulatory review.
Officials will continue monitoring the recall process and assess whether further regulatory measures are required based on the company’s response.
The regulator has advised healthcare professionals, distributors and retailers to comply with the recall directive and ensure that the affected products are removed from circulation.