The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0996-2015·Announced 2015-05-20

Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

Akorn, Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim Oral Suspension because the sulfamethoxazole component failed to meet dissolution specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality issue rather than a direct safety hazard like contamination or mislabeling of a common allergen.

Plain-English summary

Akorn, Inc. is recalling 326,666 bottles of Sulfamethoxazole and Trimethoprim Oral Suspension, USP, 200 mg/40 mg per 5 mL, Grape Flavor, 16 fl oz (473 mL). The product is manufactured by Hi-Tech Pharmacal Co. Inc. and distributed nationwide and in Puerto Rico.

The recall was initiated because the product failed to meet dissolution specifications for the sulfamethoxazole component. This means the drug may not dissolve in the body as intended, potentially affecting its therapeutic effectiveness.

Consumers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact their pharmacist or healthcare provider for a replacement or further instructions.

The recalled product

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
Manufacturer
Akorn, Inc.
Category
Drug — Antibiotic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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