The Recall Desk
ModerateFDA (Drugs)·D-1420-2015·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

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 use of, or exposure to, the product is not likely to cause adverse health consequences. The hazard is a chemical contamination (benzophenone) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Mutual Pharmaceutical Company, Inc. is recalling 25,272 bottles of Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles (NDC 53489-368-01). The recall is due to chemical contamination where benzophenone leached from the product label varnish.

The affected lots are 6669101 and 6669201 (expiring 12/15) and 6708201 and 6708301 (expiring 8/16). These products were distributed nationwide.

Consumers should check their medication for these specific lot numbers and expiration dates. If the medication 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
Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01
Manufacturer
Mutual Pharmaceutical Company, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
25,272

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: 6669101 & 6669201
  • exp 12/15 and 6708201 & 6708301
  • exp 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 →

Related recalls

Same manufacturer · Mutual Pharmaceutical Company, Inc.

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Same hazard · chemical contamination

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