The Recall Desk
LowFDA (Drugs)·D-1422-2015·Announced 2015-09-16

Mutual Pharmaceutical Recalls Felodipine Tablets Due to Chemical Contamination

Mutual Pharmaceutical is recalling specific lots of Felodipine Extended-Release Tablets because benzophenone leached from the label varnish.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.

Plain-English summary

Mutual Pharmaceutical Company, Inc. is recalling 63,975 bottles of Felodipine Extended-Release Tablets, 10 mg, 100 count bottles. The affected product is prescription-only and was distributed nationwide. The recall involves specific lot numbers 6667301 (exp 11/15), 6667401 (exp 11/15), and 6699201 (exp 6/16).

The recall was initiated due to chemical contamination. Specifically, benzophenone was found to have leached from the product label varnish. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific NDC 53489-370-01 and the listed lot numbers. If the product matches the recalled description, it should be discontinued and returned to the supplier or disposed of according to local regulations.

The recalled product

Product
Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01
Manufacturer
Mutual Pharmaceutical Company, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
63,975

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 (3)

  • lot #s: 6667301 & 6667401
  • exp 11/15 and 6699201
  • exp 6/16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Mutual Pharmaceutical Company, 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 6 products in this recall →

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Same manufacturer · Mutual Pharmaceutical Company, Inc.

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Same hazard · chemical contamination

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