The Recall Desk
SevereFDA (Drugs)·D-1873-2019·Announced 2019-09-25

Aurolife Pharma Recalls Wal-Fex Tablets Due to Impurity Failures

Aurolife Pharma is recalling 4,920 cartons of Wal-Fex (Fexofenadine Hydrochloride) 180 mg tablets nationwide because they failed impurity and degradation specifications.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies this as a Class II recall. Per the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving structural defects or significant potential for harm, even if specific hospitalization reports are not detailed in the provided snippet.

Plain-English summary

Aurolife Pharma, LLC is recalling 4,920 cartons of Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons. The product is distributed by Walgreen Co. and carries NDC 0363-0097-55. The specific lot affected is 06718027A1 with an expiration date of 09/21.

The recall was initiated because the product failed impurities and degradation specifications. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The product was distributed nationwide in the USA. Consumers who have this specific lot of Wal-Fex tablets should stop using them and contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

Product
Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55.
Manufacturer
Aurolife Pharma, LLC
Category
Drug — Prescription/OTC Medication
Hazard
Affected units
4,920

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 (2)

  • Lot #: 06718027A1
  • Exp 09/21

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Aurolife Pharma, 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 11 products in this recall →

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