Amlodipine recalls

The FDA has published 39 recalls involving Amlodipine since 2013. The latest was reported on 29 Jul 2026. Most were for manufacturing (cgmp) deviations. Aurobindo Pharma USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls39since 2013

Last 12 months2reported

Class I00% of total

Ongoing15latest 29 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 1 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 1 1Jul 0 0

Severity split

Class I 0 0%Class II 32 82%Class III 7 18%

Why amlodipine is recalled

Companies

Aurobindo Pharma USA615%
Mylan Pharmaceuticals615%
Ascend Laboratories410%
Mylan Laboratories Limited, (Nashik FDF)410%
American Health Packaging38%
Wockhardt Usa38%
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)38%
Pfizer25%

Brands

By year

202625%
202513%
202313%
202213%
202113%
202025%
2019513%
2018923%
201713%
2016513%

Ongoing amlodipine recalls

15 active

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
10 Jun 2026Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
20 Aug 2025Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
27 Mar 2019Drug	CLASS II	Amlodipine and Valsartan Tablets USP 10mg/160mg recalledAmlodipine And Valsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
23 Jan 2019Drug	CLASS II	Amlodipine and Valsartan Tablets USP 10 mg/160 mg recalledAmlodipine And Valsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
23 Jan 2019Drug	CLASS II	Amlodipine and Valsartan Tablets USP 5 mg/160 mg recalledAmlodipine And Valsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide

All amlodipine recalls, newest first

39 total

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
10 Jun 2026Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
20 Aug 2025Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
19 Jul 2023Drug	CLASS III	Amlodipine Besylate Tablets, USP 10 mg recalled by Lupin PharmaceuticalsAmlodipine Besylate	Lupin Pharmaceuticals	Potency & Assay	Nationwide
9 Mar 2022Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg recalledAmlodipine And Olmesartan Medoxomil	Macleods Pharma Usa	Manufacturing (CGMP) Deviations	Nationwide
2 Jun 2021Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
19 Feb 2020Drug	CLASS II	Caduet (amlodipine besylate/atorvastatin calcium) Tablets recalledCaduet	Pfizer	Packaging Defects	Nationwide
19 Feb 2020Drug	CLASS II	Caduet (amlodipine besylate/atorvastatin calcium) Tablets recalledCaduet	Pfizer	Packaging Defects	Nationwide
27 Mar 2019Drug	CLASS II	Amlodipine and Valsartan Tablets USP 10mg/160mg recalledAmlodipine And Valsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
23 Jan 2019Drug	CLASS II	Amlodipine and Valsartan Tablets USP 10 mg/160 mg recalledAmlodipine And Valsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide

Should you stop taking Amlodipine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.