The Recall Desk
HighFDA (Drugs)·D-0901-2023·Announced 2023-07-19

Berkley Jensen Allergy Relief Recalled for Failed Quality Specifications

L. Perrigo Company is recalling Berkley Jensen Allergy Relief tablets due to failed product quality specifications involving impurities and degradation. Consumers should verify their lot numbers and expiration dates.

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 of a drug product with failed quality control specifications for impurities and degradation products. No illnesses or injuries have been reported, but the product integrity issue represents a potential health risk, meeting the High severity threshold for risk-of-harm products without reported adverse events.

Plain-English summary

L. Perrigo Company is recalling Berkley Jensen Allergy Relief (Fexofenadine Hydrochloride) 180 mg tablets nationwide. The FDA classified this as a Class II recall due to failed impurities and degradation product specifications. Approximately 23,868 cartons of the affected product were distributed.

The recalled product consists of 150-count cartons distributed by BJ's Wholesale Club. The affected lots include: Lot #2DV1863 and 2HV2698 (Exp. 12/23), Lot #2GV1583 (Exp. 02/24), and Lot #2GV1950 and 2HV2697 (Exp. 01/24). The product NDC is 68391-847-47.

Consumers with affected lots should stop using the product and contact their pharmacy or BJ's Wholesale Club for a refund or replacement. Consult your healthcare provider if you have questions about your allergy medication alternatives.

The recalled product

Product
BERKLEY JENSEN ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
Brand
BERKLEY JENSEN ALLERGY RELIEF
Manufacturer
L. Perrigo Company
Category
Drug — OTC Allergy Relief
Hazard
Affected units
23,868

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)

  • Lot #:2DV1863
  • 2HV2698
  • Exp. date 12/23
  • 2GV1583
  • Exp. date 02/24
  • 2GV1950
  • 2HV2697
  • Exp. Date 01/24.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by L. Perrigo Company 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 13 products in this recall →

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