The Recall Desk
ModerateFDA (Drugs)·D-0749-2022·Announced 2022-04-13

Sucralfate Oral Suspension Recalled Due to Label Mix-Up

DASH Pharmaceuticals is recalling Sucralfate Oral Suspension nationwide due to a labeling mix-up affecting approximately 45,940 unit dose cups.

What this means for you

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: FDA Class II recall with no reported illnesses or injuries. The source indicates a labeling mix-up with no specified hazard details, consistent with a minor labeling error.

Plain-English summary

DASH Pharmaceuticals LLC is recalling Sucralfate Oral Suspension, USP 1g/10mL, packaged in 10 mL unit dose cups, due to a labeling mix-up. The recall involves two lot numbers: Lot #376908P40 (40-case, NDC 69339-148-17, expiring 02/28/2023) and Lot #376908P100 (100-case, NDC 69339-148-19, expiring 02/28/2023). Approximately 45,940 unit dose cups were distributed nationwide.

Patients and healthcare providers with affected batches should consult a healthcare provider for guidance.

The recalled product

Product
Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458.
Manufacturer
DASH Pharmaceuticals LLC
Category
Drug
Hazard
  • mis-labeling

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 (3)

  • Lot #: a) 376908P40
  • Exp. Date 02/28/2023
  • b) 376908P100

Distribution

Distributed nationwide across the United States.

Related recalls

Same category