UnratedDrug recall · FDA · Published October 23, 2020
Heritage Pharmaceuticals recalls Felodipine tablets due to impurity risk
Heritage Pharmaceuticals recalls 10mg Felodipine Extended Release Tablets (100-count) due to impurities found in stability testing. This recall affects Rx-only products made in India with specific NDC and lot numbers.
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Take action
Contact the company
📍Recalling firmHeritage Pharmaceuticals Inc1 Tower Center Blvd Ste 1700 · East Brunswick, NJ 08816-1145
“Heritage Pharmaceuticals recalls Felodipine tablets due to impurity risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36701-heritage-pharmaceuticals-recalls-felodipine-tablets-due-to-impurity-risk. Based on FDA recall #D-0108-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0108-2021%22&limit=1).
Heritage Pharmaceuticals Inc recalled Felodipine Extended Release Tablets, USP 10 mg, 100-count bottles due to failed impurity specifications, the FDA said on Oct. 23, 2020. The recall involves 7,176 units distributed nationwide.
Out-of-specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A, according to the FDA. The product failed impurities and degradation specifications.
Context
GovInfoNow's records show Heritage Pharmaceuticals Inc has 11 other recalls on record since Feb. 25, 2015. Other recent recalls of similar products include Heritage Pharma Recalls Clindamycin Oral Solution Due to Foreign Particles (July 30, 2026), Heritage Pharmaceuticals Desipramine Tablets Recall: N-Nitroso Impurity Risk (Oct. 6, 2025), and Heritage Pharmaceuticals Desmopressin Tablets 0.2mg Recall: Subpotent Drug Risk (Nov. 23, 2022). Other recent recalls of similar products include Sun Pharmaceutical Fexofenadine 180mg Tablets Recall: Impurities Risk Safety (June 1, 2026), Unichem Bisoprolol/Hydrochlorothiazide Tablets Recall: N-Nitroso Impurity Risk (Jan. 21, 2026), and Ajanta Pharma Fluphenazine Tablets Recall: Impurity Risk in 100-Count Bottles (Aug. 25, 2026).
How to tell if you have this one
Check for the 100-count bottle labeled 'Felodipine Extended Release Tablets, USP 10 mg' with NDC 23155-050-01 and lot number 18029979. The product was made in India and distributed by Heritage Pharmaceuticals Inc.
Brand
Heritage Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Medication
Look for the specific NDC number 23155-050-01 and lot number 18029979 on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0108-2021 (October 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0108-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.