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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83581

11 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 23, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Aurolife Pharma, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

11 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 11

Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21

D-1864-2019
Recall number
D-1864-2019
Initiated
August 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Aurolife Pharma, LLC
Quantity
8,240 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot #: 067180008A, Exp 03/21

Distribution pattern

Nationwide in the USA

drug · product 2 of 11

Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785.

D-1865-2019
Recall number
D-1865-2019
Initiated
August 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Aurolife Pharma, LLC
Quantity
a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot #s: a) 067180025D1, Exp 07/21; b) 067180025B1, Exp 07/21; c) 067180025A1, Exp 07/21; d) 067180025C1, Exp 07/21

Distribution pattern

Nationwide in the USA

drug · product 3 of 11

Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23.

D-1866-2019
Recall number
D-1866-2019
Initiated
August 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Aurolife Pharma, LLC
Quantity
3240 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot #: 067180024A1, Exp 07/21

Distribution pattern

Nationwide in the USA

drug · product 4 of 11

fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.

D-1867-2019
Recall number
D-1867-2019
Initiated
August 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Aurolife Pharma, LLC
Quantity
71,748 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot #'s: 067180009A, Exp 03/21; 067180013A, 067180014A, 067180015A, Exp 04/21; 067180018A, Exp 05/21; 067180020A, Exp 06/21; 067180021A1, 067180022A1, Exp 07/21; 06718028A1, 06718028B1, Exp 09/21; 06719001A3, Exp 01/22

Distribution pattern

Nationwide in the USA

drug · product 5 of 11

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.

D-1868-2019
Recall number
D-1868-2019
Initiated
August 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Aurolife Pharma, LLC
Quantity
a) 11,928 cartons; b) 288 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot #s: a) 067180016B, Exp 05/21 and b) 067180024F1, Exp 07/21

Distribution pattern

Nationwide in the USA

drug · product 6 of 11

Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62.

D-1869-2019
Recall number
D-1869-2019
Initiated
August 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Aurolife Pharma, LLC
Quantity
129,600 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot #s: 067180010A, Exp 03/21; 067180023C1, 067180024D1, Exp 07/21

Distribution pattern

Nationwide in the USA

drug · product 7 of 11

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104.

D-1870-2019
Recall number
D-1870-2019
Initiated
August 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Aurolife Pharma, LLC
Quantity
a) 10,992 cartons; b) 24,792 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot #s: a) 067180010B, Exp 03/21; 067180024E1, Exp 07/21; b) 067180016A, Exp 05/21

Distribution pattern

Nationwide in the USA

drug · product 8 of 11

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.

D-1871-2019
Recall number
D-1871-2019
Initiated
August 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Aurolife Pharma, LLC
Quantity
6104 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

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

Distribution pattern

Nationwide in the USA

drug · product 9 of 11

Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09.

D-1872-2019
Recall number
D-1872-2019
Initiated
August 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Aurolife Pharma, LLC
Quantity
240 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot #: 067180026A1, Exp 07/21

Distribution pattern

Nationwide in the USA

drug · product 10 of 11

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.

D-1873-2019
Recall number
D-1873-2019
Initiated
August 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Aurolife Pharma, LLC
Quantity
4920 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot #: 06718027A1, Exp 09/21

Distribution pattern

Nationwide in the USA

drug · product 11 of 11

Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.

D-1874-2019
Recall number
D-1874-2019
Initiated
August 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Aurolife Pharma, LLC
Quantity
4536 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot #: 067180024B1, Exp 07/21

Distribution pattern

Nationwide in the USA