The Recall Desk
HighFDA (Drugs)·D-1450-2022·Announced 2022-08-31

Allergy Medications Recalled Due to Improper Storage Temperature Conditions

Family Dollar Stores is recalling multiple allergy and sinus medications because they were held outside appropriate storage temperature conditions, which may affect their safety and efficacy.

What this means for you

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 CGMP deviations that could compromise pharmaceutical safety and efficacy. No illnesses or injuries have been reported, which prevents a higher severity score, but the risk-of-harm nature of the defect (improper storage affecting medication integrity) supports a High severity rating.

Plain-English summary

Family Dollar Stores, LLC is recalling multiple allergy and sinus medication products distributed nationwide. The affected products were distributed between April 30, 2022 and June 10, 2022.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations: the products were held outside appropriate storage temperature conditions. Improper storage conditions can affect the safety and efficacy of pharmaceutical products.

Affected consumers should discontinue use of the recalled products. The recalled items should be returned to Family Dollar Stores for a refund.

The recalled product

Product
QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU 916003 QP ALLERGY MULTI SYMPTOM CAPLET 24CT SKU 916918 BENADRYL D CHILD ALLERGY SINUS GRAPE 4FO SKU 901738 GOOD SENSE CHILD ALLERGY CHERRY 4 FL OZ SKU 916917 BENADRYL ALLERGY CONGESTN
Manufacturer
Family Dollar Stores, Llc.
Hazard
  • improper-storage
  • temperature-deviation

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 (8)

  • SKUs: 900449
  • 916003
  • 916918
  • 901738
  • 916917
  • 999834
  • 902217
  • 916715

Distribution

Distributed nationwide across the United States.