Amlodipine and Olmesartan Medoxomil Tablets Recalled for cGMP Deviations
Macleods Pharma USA is recalling one lot of Amlodipine and Olmesartan Medoxomil Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated by the manufacturer.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall with no reported illnesses or injuries stated in the source text. The hazard is a manufacturing practice deviation rather than contamination or a direct safety threat, making this a precautionary recall that meets the Moderate severity threshold.
Plain-English summary
Macleods Pharma USA, Inc. is voluntarily recalling 3,672 bottles of Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg in 30-count bottles (NDC 33342-192-07, Lot# BAD62101A, Exp 2/2024) distributed nationwide in the United States.
The recall was initiated due to cGMP deviations identified in the manufacturing process. The FDA classified this as a Class II recall on March 9, 2022, and the manufacturer began notification by letter on February 15, 2022.
Patients currently taking this medication should contact their healthcare provider or pharmacist before stopping use. The product is an oral prescription medication used to treat high blood pressure. The recall status is terminated as of February 17, 2023.
The recalled product
- Product
- AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
- Brand
- AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Manufacturer
- Macleods Pharma Usa Inc
- Affected units
- 3,672
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: BAD62101A
- Exp 2/2024
UPCs (8)
- 0333342192073
- 0333342191076
- 0333342192103
- 0333342190079
- 0333342193100
- 0333342191106
- 0333342193070
- 0333342190109
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · AMLODIPINE AND OLMESARTAN MEDOXOMIL
- ModerateFDA Recalls Amlodipine and Olmesartan Tablets Over Failed Dissolution Test
FDA (Drugs) · 2026-07-29
- HighAscend amlodipine and olmesartan tablets failed dissolution specifications
FDA (Drugs) · 2026-06-10
- HighAmlodipine and olmesartan tablets recalled after failing dissolution specification testing
FDA (Drugs) · 2025-08-20
- Moderate
- LowAurobindo Recalls Amlodipine and Olmesartan Medoxomil Tablets Due to Discoloration
FDA (Drugs) · 2018-12-12
Same manufacturer · Macleods Pharma Usa Inc
See all →- HighMacleods levothyroxine 150 microgram tablets recalled as a subpotent drug
FDA (Drugs) · 2026-04-01
- HighLosartan Potassium and Hydrochlorothiazide Tablets Recalled for Foreign Plastic Contamination
FDA (Drugs) · 2024-05-22
- ModerateLevofloxacin Tablets Recalled for Embossing and Packaging Insert Mismatch
FDA (Drugs) · 2023-01-25
- ModerateEszopiclone sleep medication recalled nationwide for shortfill packaging defect
FDA (Drugs) · 2022-07-13
- HighFDA Recalls Losartan-Hydrochlorothiazide Tablets for Manufacturing Quality Deviations
FDA (Drugs) · 2022-07-06
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- HighAscend Recalls Olmesartan Medoxomil Tablets Due to cGMP Deviations
FDA (Drugs) · 2020-02-12
- ModerateFDA Recalls Amlodipine and Olmesartan Tablets Over Failed Dissolution Test
FDA (Drugs) · 2026-07-29
- Moderate
- ModerateOlanzapine 10 mg tablets recalled due to cGMP deviations
FDA (Drugs) · 2022-03-09
- HighAmlodipine and olmesartan tablets recalled after failing dissolution specification testing
FDA (Drugs) · 2025-08-20
- HighAscend amlodipine and olmesartan tablets failed dissolution specifications
FDA (Drugs) · 2026-06-10