CLASS II Drug recall · Reported 25 Sep 2019 · FDA Enforcement Report

Fexofenadine HCL Tablets USP, 180 mg, 500's Brite Stock recalled

Aurolife Pharma is recalling Fexofenadine HCL Tablets USP, 180 mg, 500's Brite Stock, distributed nationwide in the US. The recall was initiated on 23 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s:067180011A, 067180012A, Exp 04/21, 06718027B1, Exp 09/21

Quantity recalled6104 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1871-2019
FDA event ID: 83581
Recalling firm: Aurolife Pharma, Dayton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 23 Aug 2019
FDA classified: 17 Sep 2019
Reported: 25 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Allergy Medication

Timeline

23 Aug 2019	Recall initiated by company
17 Sep 2019	Classified by FDA	+25 days
25 Sep 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities/Degradation Specifications

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications

Which lots are affected?

Lot #s:067180011A, 067180012A, Exp 04/21, 06718027B1, Exp 09/21

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

10 other products · FDA event 83581

This product is part of a recall event; the main page for the event is Fexofenadine Hydrochloride Tablets USP, 180 mg recalled.

Reported	Class	Recall	Company	Reason	Where
25 Sep 2019	CLASS II	Fexofenadine Hydrochloride Tablets USP, 180 mg recalled	Aurolife Pharma	Potency & Assay	Nationwide
25 Sep 2019	CLASS II	Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg recalled	Aurolife Pharma	Potency & Assay	Nationwide
25 Sep 2019	CLASS II	Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg recalled	Aurolife Pharma	Potency & Assay	Nationwide
25 Sep 2019	CLASS II	fexofenadine hydrochloride tablets USP, 180 mg, Member's Mark recalled	Aurolife Pharma	Potency & Assay	Nationwide
25 Sep 2019	CLASS II	Allergy Relief (fexofenadine hydrochrloride) tablets recalled	Aurolife Pharma	Potency & Assay	Nationwide
25 Sep 2019	CLASS II	Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg recalled	Aurolife Pharma	Potency & Assay	Nationwide
25 Sep 2019	CLASS II	Fexofenadine Hydrochloride Tablets USP, 180 mg recalled	Aurolife Pharma	Potency & Assay	Nationwide
25 Sep 2019	CLASS II	Fexofenadine Hydrochrloride Tablets USP, 180 mg recalled	Aurolife Pharma	Potency & Assay	Nationwide
25 Sep 2019	CLASS II	Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, equate recalled	Aurolife Pharma	Potency & Assay	Nationwide
25 Sep 2019	CLASS II	Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg recalled	Aurolife Pharma	Potency & Assay	Nationwide

More recalls from Aurolife Pharma

All 14

Reported	Class	Recall	Company	Reason	Where
28 Jun 2023Drug	CLASS III	Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate	Aurolife Pharma	Potency & Assay	Nationwide
28 Dec 2022Drug	CLASS II	Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate	Aurolife Pharma	Potency & Assay	Nationwide
6 Apr 2022Drug	CLASS II	Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate	Aurolife Pharma	Foreign Material	Nationwide
25 Sep 2019Drug	CLASS II	Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg recalled	Aurolife Pharma	Potency & Assay	Nationwide
25 Sep 2019Drug	CLASS II	Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, equate recalled	Aurolife Pharma	Potency & Assay	Nationwide

Other Fexofenadine recalls

All 32

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Drug	CLASS III	Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
31 Jan 2024Drug	CLASS II	Fexofenadine Hydrochloride Tablets, USP 180mg recalledFexofenadine Hydrochloride	SUN Pharmaceutical Industries	Sterility	Nationwide
19 Jul 2023Drug	CLASS II	aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg recalledExchange Select Aller Ease	L. Perrigo	Potency & Assay	Nationwide
19 Jul 2023Drug	CLASS II	Allergy Aller-fex, Fexofenadine Hydrochloride Tablets, 180 mg recalledKirkland Signature Aller Fex	L. Perrigo	Potency & Assay	Nationwide
19 Jul 2023Drug	CLASS II	Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride recalledBerkley Jensen Allergy Relief	L. Perrigo	Potency & Assay	Nationwide