CLASS III Drug recall · Reported 27 May 2015 · FDA Enforcement Report
Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy recalled
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine (10 X, distributed nationwide in the US. The recall was initiated on 26 Mar 2015 and the FDA has classified it as Class III.
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-1083-2015
- FDA event ID
- 70857
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Mar 2015
- FDA classified
- 15 May 2015
- Reported
- 27 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 26 Mar 2015 | Recall initiated by company | |
| 15 May 2015 | Classified by FDA | +50 days |
| 27 May 2015 | Published in enforcement report | +12 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: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine 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
Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
Which lots are affected?
Lot #: 3051728, 3053762, Exp. 4/2015
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
All 22Other Fexofenadine recalls
All 32| 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 |