The Recall Desk
ModerateFDA (Drugs)·D-193-2013·Announced 2013-03-20

Teva Recalls Terazosin Hydrochloride Capsules Due to Foreign Capsule Presence

Teva Pharmaceuticals USA is recalling specific lots of Terazosin Hydrochloride Capsules because a foreign capsule was found in one bottle.

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 and involves a foreign object contamination that is a low-risk physical hazard without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 3,913 bottles of Terazosin Hydrochloride Capsules, 2 mg. The affected product is packaged in 100-count bottles (NDC 0093-4337-01) and 1000-count bottles (NDC 0093-4337-10). The specific lot number is N03029 with an expiration date of 03/14. The product was manufactured in India by Intas Pharmaceuticals Ltd. for Teva Pharmaceuticals USA.

The recall is being conducted due to the presence of a foreign capsule found in one bottle. The agency has classified this recall as Class II. The product was distributed nationwide.

Consumers should check their medication for the specific NDC numbers and lot number listed above. If the product matches the recalled description, they should stop using it and contact their pharmacist or healthcare provider for guidance on replacement or disposal.

The recalled product

Product
Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India - 382 210; Manufactured For: Teva Pharmaceuticals US
Affected units
3,913

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 # N03029
  • Exp 03/14

Distribution

Distributed nationwide across the United States.