Amlodipine is a calcium channel blocker prescribed for high blood pressure and chest pain. We track every FDA enforcement recall involving Amlodipine (Norvasc) — 39 recalls in our database, including 15 active.
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Ascend Laboratories, LLC — Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Recall D-0712-2026
Ascend Laboratories, LLC — Failed Dissolution Specifications: low dissolution results
Recall D-0576-2025
Lupin Pharmaceuticals Inc. — Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Recall D-0542-2025
Lupin Pharmaceuticals Inc. — Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Recall D-0899-2023
Macleods Pharma Usa Inc — cGMP deviations
Recall D-0632-2022
Cardinal Health Inc. — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall D-0509-2021
Pfizer Inc. — Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Recall D-0842-2020
Pfizer Inc. — Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Recall D-0841-2020
Showing 8 of 39. See all Amlodipine recalls.
This page is for information only and isn’t medical advice. Always follow your clinician’s guidance.
The FDA publishes recalls, but most never make the news. The reliable way is an automated alert: sign up free and we’ll email you when a Amlodipine recall is issued.
Most prescriptions filled in the US are generics, so most recalls involve generic products. A recall doesn’t mean the drug itself is unsafe — it usually affects specific lots or manufacturers.
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