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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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 →Related recalls
Same manufacturer · Aurolife Pharma, LLC
See all →- ModerateGlycopyrrolate Tablets Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2023-06-28
- HighGlycopyrrolate Tablets Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2022-12-28
- HighGlycopyrrolate Tablets Recalled Due to Glass Pieces in Sealed Bottles
FDA (Drugs) · 2022-04-06
- SevereAurolife Recalls Fexofenadine Tablets Due to Impurity Failures
FDA (Drugs) · 2019-09-25
- SevereAurolife Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures
FDA (Drugs) · 2019-09-25
Same hazard · impurity
See all →- ModerateAjanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2026-09-16
- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
Similar recalls
- ModerateWal-Fex Fexofenadine Tablets Recalled for Impurity Specifications
FDA (Drugs) · 2022-01-12
- ModerateWal-Fex Fexofenadine Hydrochloride Tablets Recalled for Impurity Specification Failure
FDA (Drugs) · 2022-01-12
- ModeratePreferred Pharmaceuticals Recalls Fexofenadine HCl Tablets Due to Impurities
FDA (Drugs) · 2019-10-02
- ModerateSun Pharmaceutical Recalls Wal-Fex D Tablets Due to Impurity Testing Failures
FDA (Drugs) · 2019-06-26
- HighFexofenadine Hydrochloride Tablets Recalled for Failed Purity Specifications
FDA (Drugs) · 2023-07-19
- HighAllergy Relief Fexofenadine Tablets Recalled for Failed Impurity Specifications
FDA (Drugs) · 2023-07-19