The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1093-2014·Announced 2014-03-12

Teva Recalls Hydroxyzine Pamoate Capsules Due to Unapproved Manufacturing Material

Teva Pharmaceuticals USA is recalling 2,494 bottles of Hydroxyzine Pamoate Capsules, 100 mg, because the active ingredient was incorrectly released for use.

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 is a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation involving an unapproved material, which fits the criteria for a moderate severity recall without reported injuries.

Plain-English summary

Teva Pharmaceuticals USA is voluntarily recalling 2,494 bottles of Hydroxyzine Pamoate Capsules, USP, 100 mg. The affected product is identified by Lot # 34017426A and has an expiration date of 10/16. The product was distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the active pharmaceutical ingredient (API) was incorrectly released for use in manufacturing, meaning an unapproved material was used in the production of the capsules.

Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance. The product is prescription-only, and patients should not attempt to self-treat or substitute medication without professional advice.

The recalled product

Product
HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE)
Brand
HYDROXYZINE PAMOATE
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard
Affected units
2,494

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 # 34017426A
  • Exp. 10/16.

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 →

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