Lower riskDrug recall · FDA · Published June 27, 2023
Lupin Amlodipine Tablets Recall: Subpotent Drug Risk
Lupin Pharmaceuticals recalls 10mg Amlodipine Besylate tablets due to subpotent drug levels. Affected lots may not provide intended medication strength. No remedy specified in official notice.
“Lupin Amlodipine Tablets Recall: Subpotent Drug Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33396-lupin-amlodipine-tablets-recall-subpotent-drug-risk. Based on FDA recall #D-0899-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0899-2023%22&limit=1).
The FDA announced on June 27, 2023, that Lupin Pharmaceuticals Inc. is recalling Amlodipine Besylate Tablets, USP 10 mg, due to subpotent drug risks from out-of-specification test results. The agency classified the recall as Class III and voluntary.
The hazard is a subpotent drug caused by out-of-specification test results observed in an assay test at the 21-month long term stability study, according to the FDA.
Context
GovInfoNow's records show Lupin Pharmaceuticals Inc. has had 90 other recalls on record since January 31, 2013. Other recent recalls of similar products include Lupin Clobetasol Cream Recall (August 3, 2026), Lupin Glucagon Emergency Kit Recall (June 23, 2026), and Lupin prednisolone acetate ophthalmic suspension recall (June 4, 2026). Other recent recalls of similar products include Ascend Laboratories recalls Amlodipine/Olmesartan tablets with low drug content (July 8, 2026), Ascend Laboratories recalls 5mg/40mg blood pressure tablets due to low drug content (May 5, 2026), and Unichem busPIRone 5mg Tablets Recall (April 13, 2026).
How to tell if you have this one
Check for the product name 'Amlodipine Besylate Tablets, USP 10 mg', 1000-count bottles, and the lot number A102887. The expiration date is June 2023.
Brand
Lupin Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Medication Details
Verify the product name, strength, and lot number on the label to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: New Jersey, Tennessee.
Recall timeline
FDA terminated this recall 9 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-0899-2023 (June 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0899-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.