CLASS II Drug recall · Reported 6 Feb 2019 · FDA Enforcement Report
Fexofenadine HCl Tablets, USP, 180 mg recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Fexofenadine HCl Tablets, USP, 180 mg, distributed nationwide in the US. The recall was initiated on 18 Jan 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-0428-2019
- FDA event ID
- 81930
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jan 2019
- FDA classified
- 4 Feb 2019
- Reported
- 6 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 18 Jan 2019 | Recall initiated by company | |
| 4 Feb 2019 | Classified by FDA | +17 days |
| 6 Feb 2019 | Published in enforcement report | +2 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: Related compound results obtained during routine stability testing was slightly elevated above specification.
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, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Fexofenadine HCl Tablets, USP, 180 mg recalled?
Yes. Mylan Pharmaceuticals recalled Fexofenadine HCl Tablets, USP, 180 mg on 18 Jan 2019. The recall is Class II and its status is Terminated. Recall number D-0428-2019.
Why was it recalled?
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Which lots are affected?
Lot #: a) 3085490, 3085491, Exp 04/19; b) 3085492, 3085493, 3085494, 3085495, 3085496, Exp 04/19
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 Mylan Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
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| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Fexofenadine recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Fexofenadine Hydrochloride Tablets, USP 180mg recalledFexofenadine Hydrochloride | Sun Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg recalledExchange Select Aller Ease | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy Aller-fex, Fexofenadine Hydrochloride Tablets, 180 mg recalledKirkland Signature Aller Fex | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride recalledBerkley Jensen Allergy Relief | L. Perrigo | Potency & Assay | Nationwide |