Prescription-Strength NSAID Recalled
Direct Rx is recalling 1410 bottles of prescription-strength ibuprofen for failing to meet impurity/degradation specifications during 18-month stability testing, according to the November 13, 2024, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following ibuprofen products, which were manufactured by Dr Reddy’s Laboratories, Shreveport, Louisiana, and packaged and distributed throughout the United States by Direct Rx:
- ibuprofen, 800 mg, in 15-count bottles (NDC 61919-0621-15), from lot 02FE2414 (Exp. 11/30/26);
- ibuprofen, 800 mg, in 30-count bottles (NDC 61919-0621-30), from lots 18JU2407 (Exp. 11/30/26); 27JY2316 (Exp. 2/28/27); and 13SE2317, 13OC2312, and 23AU2307 (Exp. 3/31/27);
- ibuprofen, 800 mg, in 40-count bottles (NDC 61919-0621-40), from lot 25SE2308 (Exp. 3/31/27);
- ibuprofen, 800 mg, in 60-count bottles (NDC 61919-0621-60), from lots 29MA2313 and 23MA2315 (Exp. 12/31/26); 25MY2304 (Exp. 1/31/27); and 26JU2313 and 27JY2314 (Exp. 2/28/27);
- ibuprofen, 800 mg, in 90-count bottles (NDC 61919-0621-90), from lots 27SE2322, 30OC2304, and 12OC2301 (Exp. 3/31/27);
- ibuprofen, 800 mg, in 100-count bottles (NDCs 61919-0621-100, 61919-0621-71), from lots 11SE2322, 02FE2419, 23JA2405, 10JA2426, 17MY2416, 05DE2312, 24OC2321, 05FE2433, 20MA2418, and 29NO2317 (Exp. 11/30/26); and
- ibuprofen, 800 mg, in 120-count bottles (NDC 61919-0621-72), from lots 31MA2308 (Exp. 12/31/26) and 25SE2305 (Exp. 3/31/27).
Direct Rx voluntarily initiated the recall on August 9, 2024, and the FDA designated it Class II on November 7, 2024. Per the classification, use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Ibuprofen 800-mg tablets 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.
