CLASS II Drug recall · Reported 25 Sep 2019 · FDA Enforcement Report
Allergy Relief (fexofenadine hydrochrloride) tablets recalled
Aurolife Pharma is recalling Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, Good Neighbor Pharmacy, 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
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-1866-2019
- 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
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #: 067180024A1, Exp 07/21
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 83581This product is part of a recall event; the main page for the event is Fexofenadine Hydrochloride Tablets USP, 180 mg recalled.
More recalls from Aurolife Pharma
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate | Aurolife Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate | Aurolife Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate | Aurolife Pharma | Foreign Material | Nationwide |
| Drug | CLASS II | Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg recalled | Aurolife Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, equate recalled | Aurolife Pharma | Potency & Assay | Nationwide |
Other Allergy Relief (fexofenadine Hydrochrloride recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg recalled | Aurolife Pharma | Potency & Assay | Nationwide |