Teva Recalls Hydroxyzine Pamoate Capsules Due to Unapproved Manufacturing Material
Teva Pharmaceuticals is recalling specific lots of Hydroxyzine Pamoate capsules because they were manufactured using an unapproved active pharmaceutical ingredient.
What this means for you
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 involves situations where use may cause temporary or medically reversible health consequences. The source text identifies a CGMP deviation regarding an unapproved material but does not report any specific illnesses, injuries, or fatalities, aligning with a moderate severity rating for a precautionary quality control recall.
Plain-English summary
Teva Pharmaceuticals USA is recalling Hydroxyzine Pamoate Capsules, USP, 25 mg, 100-count bottles. The recall affects approximately 35,746 capsules from two specific lots: Lot # 34016752A and Lot # 34016753A, both with an expiration date of 09/16. The product is distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the active pharmaceutical ingredient (API) used in the manufacturing process was incorrectly released for use, meaning an unapproved material was utilized in the production of the capsules.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE)
- Brand
- HYDROXYZINE PAMOATE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Affected units
- 35,746
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 (3)
- Lot # 34016752A
- Exp. 09/16. Lot # 34016753A
- Exp. 09/16.
UPCs (2)
- 0305550302025
- 0305550323020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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