CLASS II Drug recall · Reported 12 Jan 2022 · FDA Enforcement Report
basic+care, allergy Fexofenadine Hydrochloride Tablets recalled
Perrigo Company is recalling basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, distributed nationwide in the US. The recall was initiated on 27 Jul 2021 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-0331-2022
- FDA event ID
- 88384
- Recalling firm
- Perrigo Company, Allegan, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jul 2021
- FDA classified
- 5 Jan 2022
- Reported
- 12 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 27 Jul 2021 | Recall initiated by company | |
| 5 Jan 2022 | Classified by FDA | +162 days |
| 12 Jan 2022 | Published in enforcement report | +7 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; Out of specification result obtained for impurity A during stability testing.
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
basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7571-47 UPC 3 70030 11470 2
Where it was distributed
Nationwide in the USA
Questions about this recall
Is basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR recalled?
Yes. Perrigo Company recalled basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR on 27 Jul 2021. The recall is Class II and its status is Terminated. Recall number D-0331-2022.
Why was it recalled?
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Which lots are affected?
Lot # 0GR0528, Exp 03/31/22; 0KR0473, Exp 04/30/22; 0LR0369, Exp 06/30/22
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Perrigo Company
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|---|---|---|---|---|---|
| Drug | CLASS II | Children's Pain & Fever Acetaminophen recalled by Perrigo Company | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Children's Cherry Flavored Acetaminophen Oral Suspension (160mg recalled | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
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| Drug | CLASS II | Acetaminophen Oral Suspension Grape Flavor, 160 mg recalled | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Maximum Strength Nasal Spray recalled by Perrigo CompanyNasal | Perrigo Company | Manufacturing (CGMP) Deviations | Nationwide |