Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1074-2014·Announced 2014-02-12

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.

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 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: impurities
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.

See all 2 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · impurities