Dr. Reddy's Laboratories, Inc. recalls IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in In
Recalled September 4, 2024 · FDA recall D-0646-2024 · Dr. Reddy's Laboratories
Hazard
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. · FDA Class II
Units
14940 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Product
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →