The Recall Desk
ModerateFDA (Drugs)·D-0355-2022·Announced 2022-01-12

Kirkland Aller-Fex tablets recalled for impurity specification failure

Perrigo Company is recalling Kirkland Aller-Fex fexofenadine hydrochloride 180 mg tablets nationwide because stability testing found out-of-specification impurity levels in affected lots.

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 a manufacturing/quality defect (out-of-specification impurity). The source text does not report any illnesses or injuries, making this a precautionary recall based on a quality control failure rather than a known harm event.

Plain-English summary

Perrigo Company PLC is recalling Kirkland Aller-Fex fexofenadine hydrochloride tablets, 180 mg, 24-hour antihistamine in 180-count bottles, due to failed impurities and degradation specifications. During stability testing, an out-of-specification result was obtained for impurity A in affected lots.

The recalled product was made in the Czech Republic and packaged by Perrigo at 515 Eastern Ave., Allegan, Michigan 49010, for Costco Wholesale Corporation. The recall affects 42,026 containers distributed nationwide in the USA. Affected lots include: 0HV1246 (expiration 1/1/2022); 0GV1974, 0GV1459 (expiration 2/1/2022); 0HV1438 (expiration 3/1/2022); 0KV2116, 0KV2117 (expiration 5/1/2022); and 0KV2119, 0LV2196, 0MV2203, 0MV2204, 0MV2205 (expiration 6/1/2022).

Consumers who have this product should stop use. Those with questions should contact Costco or consult a healthcare provider.

The recalled product

Product
KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech Republic, Packaged by Perrigo 515 Eastern Ave., Allegan, MI 49010, For Costco Wholesale Corporation. P.O. Box 34535 Seattle, WA 98124-1535, NDC 63981-571-48, U
Manufacturer
Perrigo Company PLC
Category
Drug — Antihistamine / OTC
Hazard
Affected units
42,026

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 (16)

  • Lot # 0HV1246
  • exp 1/1/2022
  • 0GV1974
  • 0GV1459
  • exp 2/1/2022
  • 0HV1438
  • exp 3/1/2022
  • 0KV2116
  • 0KV2117
  • exp 5/1/2022
  • 0KV2119
  • 0LV2196
  • 0MV2203
  • 0MV2204
  • 0MV2205
  • exp 6/1/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 30 recalled by Perrigo Company PLC 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 30 products in this recall →

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