Hydroxyzine Hydrochloride Oral Solution recalled for foreign substance
ANI Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution due to the presence of a foreign substance. The affected lot is S25133A, 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: This is an FDA Class III recall. The source text does not report any illnesses, injuries, or confirmed adverse events. The hazard is a foreign substance, which is a physical contamination concern but classified by the FDA as unlikely to cause adverse health consequences in this classification tier.
Plain-English summary
ANI Pharmaceuticals, Inc. is recalling Hydroxyzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL bottles (NDC 70954-912-10) due to the presence of a foreign substance. A total of 6564 bottles of Lot S25133A have been distributed nationwide in the USA.
Patients taking this product who are concerned about their medication should contact their pharmacist or healthcare provider. The product should not be used if a foreign substance is observed or suspected.
The recalled product
- Product
- HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
- Brand
- HYDROXYZINE HYDROCHLORIDE
- Manufacturer
- ANI Pharmaceuticals, Inc.
- Hazard
- Affected units
- 6,564
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 (1)
- Lot S25133A
UPCs (1)
- 0370954912101
Distribution
Distributed nationwide across the United States.
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