The Recall Desk
ModerateFDA (Drugs)·D-493-2014·Announced 2014-01-22

FDA Recalls Bisacodyl Tablets Due to Potential Labeling Error

Aidapak Services, LLC is recalling 100-tablet bottles of Bisacodyl EC 5 mg tablets because they may be mislabeled as Cholecalciferol 400 units.

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: The recall is classified as FDA Class II and involves a labeling mixup. While mislabeling can lead to incorrect medication use, the source does not report any illnesses or injuries, fitting the criteria for a moderate severity labeling error.

Plain-English summary

Aidapak Services, LLC is recalling 100-tablet bottles of Bisacodyl EC, Tablet, 5 mg, Over The Counter (NDC 00904792760). The recall is due to a labeling error where the product may be mislabeled as Cholecalciferol, Tablet, 400 units (NDC 00904582360).

The affected product has the pedigree code AD34931_1 and an expiration date of 5/9/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers should check their medication for the specific NDC and pedigree code listed above. If the product matches the description, they should stop using it and contact their pharmacist or the recalling firm for instructions on return or replacement.

The recalled product

Product
BISACODYL EC, Tablet, 5 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904792760
Affected units
100

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 (4)

  • BISACODYL EC
  • Tablet
  • 5 mg has the following code Pedigree: AD34931_1
  • EXP: 5/9/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 recalled by Aidapak Services, LLC 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 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

See all →