Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0631-2017·Announced 2017-04-12

Alvogen Recalls Nifedipine Tablets Due to Sorafenib Cross-Contamination

Alvogen Inc. is recalling Nifedipine Extended-Release Tablets, 90 mg, due to cross-contamination with sorafenib powder found in the inlet air duct.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard involves cross-contamination with sorafenib, a potent drug, but no illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity score.

Plain-English summary

Alvogen Inc. is recalling Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only. The recall is due to cross-contamination with another product, specifically residual powder found in the inlet air duct that was identified as sorafenib.

The affected product is manufactured for Alvogen Inc. in Pine Brook, NJ, and carries NDC 47781-370-01. The recall covers specific lots with expiration dates ranging from 03/2018 to 10/2018, including lot numbers BXH1P51, BXH66D1, BXH1P51A, BXH5ZS1, BXH1P52, BXHBKF1A, and BXHB8S1A. The distribution pattern is listed as nationwide.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider regarding alternative treatments if they have been using the recalled medication.

The recalled product

Product: Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01.
Manufacturer: Alvogen, Inc
Category: Drug — Prescription Medication
Hazard: cross-contamination
foreign-substance

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 (10)

Lot #: BXH1P51
BXH66D1
BXH1P51A
BXH5ZS1
Exp. 03/2018
BXH1P52
Exp. 05/2018
BXHBKF1A
and BXHB8S1A
Exp. 10/2018.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Alvogen, Inc 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 9 products in this recall →

Same manufacturer · Alvogen, Inc

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Same hazard · cross contamination