FDA Orders Recall of ₹2.45 Crore Worth of Aciloc Plus Medicines Over Risk of Medication Confusion

Cadila Pharmaceuticals asked to withdraw products across Maharashtra after similar branding of medicines with different active ingredients raised safety concerns.
FDA Orders Recall of ₹2.45 Crore Worth of Aciloc Plus Medicines Over Risk of Medication Confusion
FDA Orders Recall of ₹2.45 Crore Worth of Aciloc Plus Medicines Over Risk of Medication ConfusionThe Bridge Chronicle
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Pune, 13th July 2026: The Maharashtra Food and Drug Administration (FDA) has directed Cadila Pharmaceuticals to immediately recall medicines worth around ₹2.45 crore from the market after finding that the company introduced products with nearly identical brand names despite using different active pharmaceutical ingredients.

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The regulator said the similarity could lead to doctors, pharmacists and patients mistakenly using the wrong medicine.

Cadila was already manufacturing Aciloc 150 and Aciloc 300, medicines used to treat acidity, heartburn and stomach ulcers. These products contain ranitidine as the active ingredient.

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The company later launched Aciloc 150 Plus and Aciloc 300 Plus, which are used for similar conditions but contain famotidine, a different acid-suppressing drug. Although both medicines are prescribed for similar ailments, they differ in their active ingredients and dosage.

According to the FDA, the addition of only a "Plus" sign to the brand name and the use of nearly identical packaging increased the possibility of medication errors.

The issue came to light during a routine FDA inspection in Amravati. Investigators found that both the older and newer versions of the medicines were being sold simultaneously, creating the potential for confusion among healthcare professionals and patients.

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Following the investigation, FDA teams raided the company's carrying and forwarding (CFA) warehouses in Pune, Nagpur and Bhiwandi (Thane). Authorities stopped the distribution of medicine stocks worth ₹89.45 lakh in Pune, ₹98.71 lakh in Nagpur, and ₹57.20 lakh in Bhiwandi, taking the total value of the recalled stock to approximately ₹2.45 crore.

FDA officials said the similarity in branding posed a serious public health concern and violated regulatory norms governing the marketing of medicines. The department has initiated legal proceedings against the company under the Drugs and Cosmetics Act, 1940.

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FDA Joint Commissioner Ganesh Rokade said that medicine names should not create confusion, as patient safety is paramount. He added that pharmaceutical companies are expected to follow regulatory guidelines while branding and marketing medicines, and appropriate legal action is being taken under the Drugs and Cosmetics Act, 1940.

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