Manufacturer
4 recalls in our database name Hetero USA Inc as the manufacturing or recalling firm.
Of the 4 recalls from Hetero USA Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Hetero USA Inc. is recalling 2,352 bottles of Pantoprazole Sodium 40mg tablets due to manufacturing deviations that caused discoloration. The affected lot (PAN22542, exp. 9/2024) was distributed nationwide.
Hetero USA Inc. is recalling 5,664 bottles of Entecavir 0.5 mg tablets because a single unknown impurity exceeded the allowed limit during stability testing.
Hetero USA Inc. is recalling 13,692 bottles of Acyclovir 800 mg tablets because human hair was found melded into the tablets.
Hetero USA Inc. is recalling 65,664 bottles of Montelukast sodium tablets due to a complaint of blue spots and powder inside a sealed bottle.