Heritage Pharmaceuticals Recalls Felodipine Extended Release Tablets Due to Impurities
Heritage Pharmaceuticals is recalling specific bottles of Felodipine Extended Release Tablets because routine testing found out-of-specification impurities.
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 is defined as unlikely to cause adverse health consequences. The issue involves out-of-specification impurities detected during routine testing without reported illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Heritage Pharmaceuticals Inc. is recalling 7,176 bottles of Felodipine Extended Release Tablets, USP 10 mg, 100-count. The affected product is identified by Lot # 18029979 and an expiration date of 1/2021. The product was distributed nationwide in the United States.
The recall was initiated because routine testing of stability samples revealed out-of-specification results for the impurity Felodipine Related compound A. This indicates that the tablets failed to meet established impurity and degradation specifications.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches these details, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
- Manufacturer
- Heritage Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 7,176
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 (2)
- Lot #: 18029979
- Exp 1/2021
Distribution
Distributed nationwide across the United States.
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