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.
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 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
- 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 →Related recalls
Same brand · HYDROXYZINE PAMOATE
- HighHydroxyzine Pamoate Capsules Recalled Due to Temperature Abuse During Manufacturing
FDA (Drugs) · 2022-06-15
- ModerateTeva Recalls Hydroxyzine Pamoate Capsules Due to Unapproved Manufacturing Material
FDA (Drugs) · 2014-03-12
Same manufacturer · Teva Pharmaceuticals USA
See all →- ModerateDoxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
- LowPrescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
- ModerateTretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
- LowMimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
- ModerateBrinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26
Same hazard · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- SevereShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- HighShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19