Impurity Prompts Tablet Recall

Dr Reddy’s Laboratories Inc. is recalling 150 040 bottles of IBU (ibuprofen) tablets because of an unknown impurity. According to the September 4, 2024, US Food and Drug Administration (FDA) Enforcement Report, testing revealed impurity results of 0.13% and 0.11%. The specification limit is 0.10%.

The recall affects the following products, which were distributed in the United States and Puerto Rico:

• IBU ibuprofen tablets, 400 mg, in 100-count bottles (NDC 55111-682-01), from lots C2207529 (Exp. 5/31/26) and C2210993 (Exp. 9/30/26);
• IBU ibuprofen tablets, 400 mg, in 500-count bottles (NDC 55111-682-05), from lots C2207530 (Exp. 5/31/26), C2210992 (Exp. 9/30/26), C2210994 (Exp. 9/30/26), C2213304 (Exp. 11/30/26), and C2213305 (Exp. 11/30/26);
• IBU ibuprofen tablets, 600 mg, in 100-count bottles (NDC 55111-683-01), from lots C2207527 (Exp. 5/31/26), C2210864 (Exp. 9/30/26), and C2213018 (Exp. 11/30/26);
• IBU ibuprofen tablets, 600 mg, in 500-count bottles (NDC 5511-683-05), from lots C2207528 (Exp. 5/31/26), C2210860 (Exp. 9/30/26), C2213016 (Exp. 11/30/26), C2213017 (Exp. 11/30/26), C2301852 (Exp. 1/31/27), C2302056 (Exp. 1/31/27), and C2302057 (Exp. 1/31/27);
• IBU ibuprofen tablets, 800 mg, in 100-count bottles (NDC 55111-684-01), from lots C2207525 (Exp. 5/31/26), and C2212902 (Exp. 11/30/26); and
• IBU ibuprofen tablets, 800 mg, in 500-count bottles (NDC 55111-684-05), from lots C2207526 (Exp. 5/31/26), C2210751 (Exp. 9/30/26), C2210752 (Exp. 9/30/26), C2212765 (Exp. 11/30/26), C2212766 (Exp. 11/30/26), C2301027 (Exp. 12/31/26), C2301063 (Exp. 12/31/26), C2301187 (Exp. 12/31/26), C2301188 (Exp. 12/31/26), C2301247 (Exp. 12/31/26), C2301356 (Exp. 1/31/27), C2301388 (Exp. 1/31/27), C2301494 (Exp. 1/31/27), C2301478 (Exp. 1/31/27), C2301617 (Exp. 1/31/27), C2303381 (Exp. 2/28/27), C2303432 (Exp. 2/28/27), C2303565 (Exp. 2/28/27), C2303630 (Exp. 2/28/27), C2303643 (Exp. 2/28/27), C2303710 (Exp. 2/28/27), C2303879 (Exp. 3/31/27), C2303806 (Exp. 3/31/27), C2303895 (Exp. 3/31/27), C2303963 (Exp. 3/31/27), C2304263 (Exp. 3/31/27), C2304264 (Exp. 3/31/27), C2304130 (Exp. 3/31/27), C2304163 (Exp. 3/31/27), and C2304427 (Exp. 3/31/27).

The affected products were made in India and distributed by Dr Reddy’s Laboratories Inc., Princeton, New Jersey.

Dr Reddy’s Laboratories voluntarily initiated the recall on August 6, 2024. On August 26, 2024, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

IBU ibuprofen tablets 400 mg, 600 mg, and 800 mg are a nonsteroidal anti-inflammatory drug (NSAID) available with a prescription. They are indicated for the relief of mild to moderate pain, relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis, and for the treatment of primary dysmenorrhea.