The Recall Desk
ModerateFDA (Drugs)·D-1312-2022·Announced 2022-08-17

Bisacodyl suppositories recalled nationwide due to improper storage

McKesson Medical-Surgical is recalling Bisacodyl suppositories stored outside label specifications. The FDA Class II recall affects 45 boxes distributed nationwide.

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: This is an FDA Class II recall involving improper storage outside drug label specifications. No illnesses or injuries have been reported, and the recall is precautionary based on CGMP manufacturing practice deviations.

Plain-English summary

Bisacodyl suppositories (10 mg strength, 100 suppositories per box, Health Star brand) manufactured by McKesson Medical-Surgical Inc. are being recalled. The product is identified by NDC 57896-443-01 and part number 444-01-HST. Approximately 45 boxes were affected.

The product was stored outside the specifications listed on the drug label. This constitutes a deviation from Current Good Manufacturing Practice standards.

The affected product was distributed nationwide throughout the United States.

Consumers who have purchased this product or have questions about the recall should contact McKesson Medical-Surgical Inc. or the FDA for further information.

The recalled product

Product
BISACODYL (BISACODYL)
Brand
BISACODYL
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Laxative / OTC
Hazard
  • improper-storage

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 (1)

  • Part# 444-01-HST

UPCs (1)

  • 0357896444051

Distribution

Distributed nationwide across the United States.

Related recalls

Same category