Sulfamethoxazole Oral Suspension (Akorn) – Dissolution Failure (2015)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
Brand
Akorn, Inc.
Lot Codes / Batch Numbers
Lot # 618358, Exp. 11/15/2015, Lot # 618646, Exp. 11/18/2015, Lot # 618649, Exp. 11/19/2015, Lot # 618652, Exp. 11/20/2015, Lot # 618746, Exp. 11/26/2015, Lot # 618749, Exp. 11/27/2015, Lot # 618934, Exp. 12/5/2015, Lot # 618940, Exp. 12/6/2015, Lot # 618946, Exp. 12/8/2015, Lot # 621496, Exp. 5/13/2016, Lot # 621890, Exp. 6/24/2016, Lot # 622779, Exp. 7/27/2016, Lot # 623389, Exp. 8/31/2016, Lot # 623829, Exp. 9/27/2016, Lot # 623946, Exp. 10/2/2016, Lot # 623952, Exp. 10/3/2016, Lot # 623955, Exp. 10/3/2016, Lot # 624147, Exp. 10/8/2016, Lot # 624153, Exp. 10/9/2016, Lot # 624159, Exp. 10/15/2016, Lot # 624162, Exp. 10/17/2016, Lot # 624271, Exp. 10/18/2016, Lot # 624274, Exp. 10/18/2016, Lot # 624490, Exp. 10/23/2016, Lot # 624493, Exp. 10/23/2016, Lot # 624496, Exp. 10/25/2016, Lot # 624499, Exp. 10/25/2016, Lot # 624744, Exp. 11/6/2016, Lot # 624747, Exp. 11/6/2016, Lot # 624750, Exp. 11/8/2016, Lot # 624753, Exp. 11/8/2016, Lot # 624836, Exp. 11/14/2016, Lot # 624839, Exp. 11/15/2016, Lot # 625120, Exp. 12/4/2016, Lot # 625123, Exp. 12/29/2016, Lot # 625126, Exp. 12/30/2016, Lot # 625795, Exp. 1/14/2017, Lot # 625918, Exp. 1/22/2017, Lot # 625921, Exp. 1/23/2017, Lot # 625924, Exp. 1/23/2017, Lot # 625927, Exp. 1/24/2017, Lot # 626211, Exp. 2/6/2017, Lot # 626465, Exp. 3/25/2017, Lot # 626735, Exp. 3/5/2017, Lot # 626743, Exp. 3/20/2017
Products Sold
Lot # 618358, Exp. 11/15/2015; Lot # 618646, Exp. 11/18/2015; Lot # 618649, Exp. 11/19/2015; Lot # 618652, Exp. 11/20/2015; Lot # 618746, Exp. 11/26/2015; Lot # 618749, Exp. 11/27/2015; Lot # 618934, Exp. 12/5/2015; Lot # 618940, Exp. 12/6/2015; Lot # 618946, Exp. 12/8/2015; Lot # 621496, Exp. 5/13/2016; Lot # 621890, Exp. 6/24/2016; Lot # 622779, Exp. 7/27/2016; Lot # 623389, Exp. 8/31/2016; Lot # 623829, Exp. 9/27/2016; Lot # 623946, Exp. 10/2/2016; Lot # 623952, Exp. 10/3/2016; Lot # 623955, Exp. 10/3/2016; Lot # 624147, Exp. 10/8/2016; Lot # 624153, Exp. 10/9/2016; Lot # 624159, Exp. 10/15/2016; Lot # 624162, Exp. 10/17/2016; Lot # 624271, Exp. 10/18/2016; Lot # 624274, Exp. 10/18/2016; Lot # 624490, Exp. 10/23/2016; Lot # 624493, Exp. 10/23/2016; Lot # 624496, Exp. 10/25/2016; Lot # 624499, Exp. 10/25/2016; Lot # 624744, Exp. 11/6/2016; Lot # 624747, Exp. 11/6/2016; Lot # 624750, Exp. 11/8/2016; Lot # 624753, Exp. 11/8/2016; Lot # 624836, Exp. 11/14/2016; Lot # 624839, Exp. 11/15/2016; Lot # 625120, Exp. 12/4/2016; Lot # 625123, Exp. 12/29/2016; Lot # 625126, Exp. 12/30/2016; Lot # 625795, Exp. 1/14/2017; Lot # 625918, Exp. 1/22/2017; Lot # 625921, Exp. 1/23/2017; Lot # 625924, Exp. 1/23/2017; Lot # 625927, Exp. 1/24/2017; Lot # 626211, Exp. 2/6/2017; Lot # 626465, Exp. 3/25/2017; Lot # 626735, Exp. 3/5/2017; Lot # 626743, Exp. 3/20/2017
Akorn, Inc. is recalling SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz due to Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026