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India's drug regulator flagged Abhayrab batch KE25012 as substandard and potentially spurious after a field sample failed a potency test.
A government document seen by Reuters said the Central Drugs Laboratory also found discrepancies in labelling, artwork, and packaging versus a reference sample.
The vaccine is described as widely used, and state regulators were asked to maintain vigilance over the batch.
Indian Immunologicals Ltd and federal regulators did not respond to requests for comment.
Why it mattersThe probe could affect vaccine trust, patient safety, and supply oversight.
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The reporting says this is not the first such concern, with counterfeit-dose issues around the vaccine having surfaced before.