The Recall Desk
ModerateFDA (Drugs)·D-0143-2017·Announced 2016-11-30

Actavis Recalls Nifedipine Capsules Due to Presence of Foreign Tablets

Actavis Elizabeth LLC is recalling Nifedipine Capsules USP, 10 mg, because the product may contain foreign tablets or capsules.

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 III, which indicates the product is not likely to cause adverse health consequences. The hazard involves the presence of foreign tablets or capsules, which is a quality control issue rather than a high-risk pathogen or structural defect.

Plain-English summary

Actavis Elizabeth LLC is voluntarily recalling Nifedipine Capsules USP, 10 mg, Rx only, 100 count bottles. The recall is being conducted because the product may contain foreign tablets or capsules.

The affected product is identified by NDC 0228-2407-10, Lot # 0598B151, and an expiration date of 03/18. A total of 27,517 bottles were distributed in the United States.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10
Affected units
27,517

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 # 0598B151
  • Exp 03/18

Distribution

Distribution scope not specified by the agency.