CLASS II Drug recall · Reported 9 Mar 2022 · FDA Enforcement Report

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg recalled

Macleods Pharma Usa is recalling Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, distributed nationwide in the US. The recall was initiated on 15 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot#: BAD62101A, Exp 2/2024

NDC33342-190, 33342-191, 33342-192, 33342-193

UPC0333342192073, 0333342191076, 0333342192103, 0333342190079, 0333342193100, 0333342191106

Quantity recalled3,672 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0632-2022
FDA event ID: 89600
Recalling firm: Macleods Pharma Usa, Plainsboro, NJ
Brand: Amlodipine And Olmesartan Medoxomil
Manufacturer: Macleods Pharmaceuticals Limited
Classification: Class II
Status: Terminated
Recall initiated: 15 Feb 2022
FDA classified: 25 Feb 2022
Reported: 9 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Blood Pressure Medication

Timeline

15 Feb 2022	Recall initiated by company
25 Feb 2022	Classified by FDA	+10 days
9 Mar 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

cGMP deviations

Product as listed by the FDA

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07.

Where it was distributed

USA Nationwide

Nationwide

Questions about this recall

Why was it recalled?

cGMP deviations

Which lots are affected?

Lot#: BAD62101A, Exp 2/2024

Where was it sold?

USA Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Macleods Pharma Usa

All 34

Reported	Class	Recall	Company	Reason	Where
1 Apr 2026Drug	CLASS II	Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium	Macleods Pharma USA	Potency & Assay	Nationwide
22 May 2024Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma USA	Foreign Material	Nationwide
25 Jan 2023Drug	CLASS III	Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa	Macleods Pharma USA	Packaging Defects	Nationwide
13 Jul 2022Drug	CLASS II	Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone	Macleods Pharma Usa	Packaging Defects	Nationwide
6 Jul 2022Drug	CLASS II	Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide

Other Amlodipine recalls

All 81

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
6 Aug 2025Drug	CLASS II	Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg recalledAmlodipine Besylate And Benazepril Hydrochloride	Lupin Pharmaceuticals	Other	Nationwide
19 Jul 2023Drug	CLASS III	Amlodipine Besylate Tablets, USP 10 mg recalled by Lupin PharmaceuticalsAmlodipine Besylate	Lupin Pharmaceuticals	Potency & Assay	Nationwide