Teva Recalls Hydralazine HCL Tablets Due to Impurity Concerns
Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 25 mg tablets because they may contain impurities outside of specification limits.
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 corresponds to a Moderate severity score when no specific hospitalizations or severe injuries are reported in the source text.
Plain-English summary
Teva Pharmaceuticals USA is recalling approximately 1,249,700 tablets of Hydralazine HCL Tablets, USP, 25 mg. The affected product is distributed nationwide by Goldline Laboratories and is identified by specific lot numbers and expiration dates listed in the recall notice.
The recall was initiated because the tablets have a potential to be out of specification for impurities throughout their shelf life. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have purchased these specific lots of Hydralazine HCL tablets should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The affected lots are #14071112AA, #14071112AB, #14071012BA, and #14071012BB, all with an expiration date of 03/14.
The recalled product
- Product
- Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister).
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,249,700
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 (5)
- lot #14071112AA
- Exp. 03/14. lot #14071112AB
- Exp. 03/14. lot # 14071012BA
- Exp. 03/14. lot #14071012BB
- Exp 03/14.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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