CLASS II Drug recall · Reported 18 Sep 2019 · FDA Enforcement Report
Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg recalled
Avkare is recalling Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg per, distributed nationwide in the US. The recall was initiated on 28 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-1875-2019
- FDA event ID
- 83700
- Recalling firm
- Avkare, Pulaski, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2019
- FDA classified
- 17 Sep 2019
- Reported
- 18 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 28 Aug 2019 | Recall initiated by company | |
| 17 Sep 2019 | Classified by FDA | +20 days |
| 18 Sep 2019 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability 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
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Failed Stability Specifications.
Which lots are affected?
Lot #s: 067180011A; 067180012A, Exp. 04/2021; 06718027B1 Exp. 09/2021
Where was it sold?
Nationwide in the U.S.
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.
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|---|---|---|---|---|---|
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