The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1420-2022·Announced 2022-08-31

PREVACID Lansoprazole 15mg Capsules Recalled Due to Storage Conditions

Family Dollar Stores is recalling PREVACID 24HR Lansoprazole 15mg capsules distributed nationwide from April 30 to June 10, 2022, because the product was stored at improper temperatures in violation of manufacturing standards. Consumers should not use this product and should contact Family Dollar Stores for a refund.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving improper storage temperature of a pharmaceutical product. While no illnesses or injuries have been reported, improper storage of medication presents a potential risk of harm by affecting drug stability and efficacy, satisfying the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Family Dollar Stores, LLC, is recalling PREVACID 24HR Lansoprazole 15mg capsules (SKU 903449) distributed to specific Family Dollar Store locations nationwide. The product was held at improper storage temperatures, constituting a violation of Current Good Manufacturing Practice (CGMP) standards.

The affected product was distributed between April 30, 2022, and June 10, 2022. The recall notice does not specify which store locations were affected or provide lot numbers for identification beyond the SKU.

Consumers who purchased this product should stop using it and contact Family Dollar Stores for information about refunds or replacements. Healthcare providers and patients taking this medication should consult with their pharmacist or doctor for alternative options if needed.

The recalled product

Product
PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug

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: 903449

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 100 recalled by Family Dollar Stores, 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 100 products in this recall →

Same manufacturer · Family Dollar Stores, Llc.

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