The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1421-2015·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 product label varnish.

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 1/5 (Low).

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

Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for minor issues.

Plain-English summary

Mutual Pharmaceutical Company, Inc. is recalling 97,859 bottles of Felodipine Extended-Release Tablets, 5 mg, 100 count bottles. The affected product is prescription-only and was distributed nationwide. The recall involves specific lot numbers with expiration dates ranging from October 2015 to August 2016.

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 violative product is not likely to cause adverse health consequences.

Consumers who have these specific bottles should stop using the medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The affected lots are identified by the following numbers and expiration dates: 6662801 (exp 10/15), 6662901 (exp 10/15), 6689601 (exp 4/16), 6689701 (exp 5/16), and 6708401 (exp 8/16).

The recalled product

Product
Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
Manufacturer
Mutual Pharmaceutical Company, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
97,859

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 (7)

  • lot #s: 6662801 & 6662901
  • exp 10/15
  • 6689601
  • exp 4/16
  • 6689701
  • exp 5/16 and 6708401
  • 8/16

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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