Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Felodipine Extended Release Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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
Affected NDC
23155-0050-01
Compare with the code on your package — it is the most precise check available.
Drug: Felodipine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Felodipine NDC 23155-0050 |
10 mg/1 | Tablet, Extended Release Oral |
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | Rx |
- Recalling firm
- Heritage Pharmaceuticals Inc
- NDC code
- 23155-050-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0108-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Felodipine recalls
See all
Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Other recalls by Heritage Pharmaceuticals Inc
All 2020 recalls
Class II · Moderate risk
Clindamycin Palmitate Hydrochloride for Oral Solution
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
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