Lannett Recalls Hydroxyzine Hydrochloride Syrup Due to Impurities
Lannett Company is recalling 8,324 bottles of Hydroxyzine Hydrochloride Syrup because cleaning procedures caused out-of-specification results for unknown impurities.
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 indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to manufacturing deviations (unknown impurities) rather than a known high-risk pathogen or structural defect.
Plain-English summary
Lannett Company, Inc. is recalling 8,324 bottles of Hydroxyzine Hydrochloride Syrup, 10 mg per 5 mL. The product is a prescription-only oral solution distributed nationwide in the USA. The specific lot number is 1097, with an expiration date of 10/18.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, cleaning procedures during manufacturing resulted in out-of-specification results for unknown impurities.
Consumers and healthcare providers should check their inventory for this specific lot and stop using the product if it matches the description. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
- Brand
- HYDROXYZINE HYDROCHLORIDE
- Manufacturer
- Lannett Company, Inc.
- Category
- Drug — Prescription Syrup
- Affected units
- 8,324
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 #: 1097
- Exp 10/18
UPCs (1)
- 0354838502800
Distribution
Distributed nationwide across the United States.
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