The Recall Desk
ModerateFDA (Drugs)·D-1427-2022·Announced 2022-08-31

Dulcolax 5 mg Tablets Recalled for Improper Storage Conditions

Dulcolax 5 mg tablets distributed to Family Dollar Stores between April 30 and June 10, 2022 are recalled because they were stored outside appropriate temperature conditions, which could affect product effectiveness.

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 for CGMP storage deviation. No illnesses or injuries have been reported. The hazard is potential loss of product efficacy due to improper storage conditions, which is a quality issue rather than a direct safety threat.

Plain-English summary

Dulcolax 5 mg tablets in 25-count boxes distributed to specific Family Dollar Store locations between April 30, 2022 and June 10, 2022 (SKU 916079) are being recalled.

The product was stored outside appropriate temperature conditions in violation of current good manufacturing practices (CGMP). This could affect the product's potency and effectiveness.

Consumers who purchased the affected product should stop using it. Contact the store or pharmacy where you purchased the product for information about returns or replacements.

The recalled product

Product
DULCOLAX 5 MG TABLET 25 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Manufacturer
Family Dollar Stores, Llc.
Category
Drug
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)

  • SKU: 916079

Distribution

Distributed nationwide across the United States.

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