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.
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 2/5 (Moderate).
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.
See all →- ModerateMutual Pharmaceutical Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Foreign Substance
FDA (Drugs) · 2016-01-27
- LowMutual Pharmaceutical Recalls Imipramine HCl Tablets Due to Chemical Contamination
FDA (Drugs) · 2015-09-16
- ModerateMutual Pharmaceutical Recalls Imipramine HCl Tablets Due to Chemical Contamination
FDA (Drugs) · 2015-09-16
- LowMutual Pharmaceutical Recalls Felodipine Tablets Due to Chemical Contamination
FDA (Drugs) · 2015-09-16
- ModerateMutual Pharmaceutical Recalls Imipramine HCl Tablets Due to Benzophenone Contamination
FDA (Drugs) · 2015-09-16
Same hazard · chemical contamination
See all →- ModerateAvid Medical Recalls 30 DAVINCI LAP/GYN Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls Plastic Trays Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls Craniotomy Packs Due to Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateHeritage Pharmaceuticals Recalls Felodipine Extended Release Tablets Due to Impurities
FDA (Drugs) · 2020-12-02
- ModerateMutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations
FDA (Drugs) · 2015-08-05
- ModerateMutual Pharmaceutical Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Foreign Substance
FDA (Drugs) · 2016-01-27
- LowMutual Pharmaceutical Recalls Fenofibric Acid Tablets Due to Labeling Error
FDA (Drugs) · 2014-01-15
- ModerateMylan Recalls Fexofenadine Tablets Due to Elevated Impurities
FDA (Drugs) · 2019-02-06
- LowTribute Pharmaceuticals Recalls Fenofibric Acid Tablets Due to Benzophenone Contamination
FDA (Drugs) · 2015-10-21