Mutual Pharmaceutical Felodipine Extended-Release Tablets Recall

Why it was recalled

Chemical Contamination; benzophenone leached from the product label varnish

Product description

Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1421-2015
Classification: Class III
Status: Terminated
Recall initiated: Jul 16, 2015
FDA report date: Sep 16, 2015
Quantity: 97,859 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Mutual Pharmaceutical Company, Inc.

Original FDA data

Every field from FDA enforcement report D-1421-2015, exactly as published.

Show all FDA fields

City: Philadelphia
State: PA
Status: Terminated
Country: United States
Event ID: 71836
Address: 1100 Orthodox St
Code information: lot #s: 6662801 & 6662901, exp 10/15, 6689601, exp 4/16, 6689701, exp 5/16 and 6708401, 8/16
Postal code: 19124-3168
Report date: Sep 16, 2015
Product type: Drugs
Recall number: D-1421-2015
Classification: Class III
Recalling firm: Mutual Pharmaceutical Company, Inc.
Product quantity: 97,859 bottles
Termination date: Oct 13, 2016
Reason for recall: Chemical Contamination; benzophenone leached from the product label varnish
Voluntary / mandated: Voluntary: Firm initiated
Product description: Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
Distribution pattern: Nationwide
Recall initiation date: Jul 16, 2015
Initial firm notification: Letter
Center classification date: Sep 9, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1421-2015, published Sep 16, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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