Mylan Recalls Fexofenadine HCl Tablets Due to Impurity Failures
Mylan Pharmaceuticals is recalling specific lots of Fexofenadine HCl 60 mg tablets because they failed impurity specifications. The recall covers 13,856 bottles distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 13,856 bottles of Fexofenadine HCl Tablets, USP, 60 mg. The affected products are sold in 60-count bottles (NDC 0378-0781-91) and 500-count bottles (NDC 0378-0781-05). The specific lot number is 3047303, with an expiration date of 04/2015. The products were distributed nationwide.
The recall was initiated because the tablets failed impurity and degradation specifications. Specifically, out-of-specification results were found for a related compound, which is a degradant of fexofenadine.
Consumers who have these specific bottles should stop using the product and contact their pharmacist or Mylan Pharmaceuticals for further instructions.
The recalled product
- Product
- Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 13,856
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3047303
- Exp 04/2015
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Mylan Pharmaceuticals Inc.
See all →- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
- HighMycophenolate Mofetil Injection Recalled Due to Precipitate in Vials
FDA (Drugs) · 2026-08-05
- HighAmnesteem isotretinoin 40 mg capsules failed dissolution specifications
FDA (Drugs) · 2026-03-11
- HighPrasugrel 5 mg Tablets Recalled Due to Failed Dissolution Specifications
FDA (Drugs) · 2025-03-26
- CriticalInsulin Glargine Prefilled Pens Recalled for Missing Label
FDA (Drugs) · 2022-08-03
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17