Mylan Recalls Fexofenadine Tablets Due to Elevated Impurities
Mylan Pharmaceuticals is recalling specific lots of Fexofenadine HCl 180 mg tablets because routine stability testing showed slightly elevated related compounds.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) in the absence of reported injuries or more severe classifications like Class I.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 88,090 bottles of Fexofenadine HCl Tablets, USP, 180 mg. The affected products are packaged in 30-count bottles (NDC 0378-0782-93) and 500-count bottles (NDC 0378-0782-05). The recall covers lots 3085490, 3085491, 3085492, 3085493, 3085494, and 3085495, all with an expiration date of 04/19.
The recall was initiated because related compound results obtained during routine stability testing were slightly elevated above specification. This is a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The affected products were distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed above and stop using the affected tablets. They should contact Mylan Pharmaceuticals or their healthcare provider for further instructions on disposal or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 88,090
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 (8)
- Lot #: a) 3085490
- 3085491
- Exp 04/19
- b) 3085492
- 3085493
- 3085494
- 3085495
- 3085496
Distribution
Distributed nationwide across the United States.
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