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All product recalls associated with SUN PHARMACEUTICAL INDUSTRIES INC.
Total Recalls
1000
Past Year
303
Class I (Serious)
34
Most Recent
Nov 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
cGMP - Water leakage
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
This recall involves the Kroger brand acetaminophen over-the-counter drug. The red, white and gray label states Kroger, Acetaminophen, Extended-Release Tablets USP, 650mg, Pain Reliever/Fever Reducer, 100 caplets. The bottle has a white continuous thread closure. The UPC number is 041260012877 with the batch codes AC45463, AC38213 or AC30682. The location of the UPC number is under the bar code on the packaging and the batch code is at the bottom of the label on the bottle.