Food, drugs, devices › Mutual Pharmaceutical Company, Inc.
Drug recall: Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, P
Mutual Pharmaceutical Company, Inc. (Philadelphia, PA) initiated this drug recall on 16 Jul 2015; FDA lists 6 product records under event 71836, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 31% of the 292 drug enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 13 Oct 2016. Initiation: voluntary: firm initiated. Mutual Pharmaceutical Company, Inc. has 5 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mutual Pharmaceutical Company, Inc., Philadelphia, PA.
Reason for recall
"Chemical Contamination; benzophenone leached from the product label varnish"
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1420-2015 | Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01 | 25,272 bottles | Class III | Terminated | 16 Sep 2015 |
| D-1421-2015 | Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01 | 97,859 bottles | Class III | Terminated | 16 Sep 2015 |
| D-1422-2015 | Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01 | 63,975 bottles | Class III | Terminated | 16 Sep 2015 |
| D-1423-2015 | Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01 | 5472 bottles | Class III | Terminated | 16 Sep 2015 |
| D-1424-2015 | Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01 | 14,112 bottles | Class III | Terminated | 16 Sep 2015 |
| D-1425-2015 | Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01 | 10,080 bottles | Class III | Terminated | 16 Sep 2015 |
Context
Other enforcement events for Mutual Pharmaceutical Company, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Oct 2015 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutua | Drug | Class II | 1 |
| 9 Jul 2015 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-2 | Drug | Class II | 3 |
| 10 Mar 2015 | Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPH | Drug | Class II | 1 |
| 27 Feb 2013 | FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90) | Drug | Class III | 3 |
All 5 events for Mutual Pharmaceutical Company, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Chemical Contamination; benzophenone leached from the product label varnish"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Oct 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.