InvaGen Pharmaceuticals, Inc. recalls Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India,
InvaGen Pharmaceuticals recalls 10 mg Amlodipine Besylate tablets due to subpotent drug quality. This means the medication may not be as effective as labeled, potentially requiring higher doses for treatment.
Lower-risk recall
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Contact the company & request your remedy
What happened, in plain English
InvaGen Pharmaceuticals is recalling 10 mg Amlodipine Besylate tablets that may not contain the full amount of active ingredient. This could lead to the medication being less effective than intended, requiring higher doses for the same treatment effect. Read more at govinfonow.com/recall/39538-invagen-amlodipine-tablets-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39538-invagen-amlodipine-tablets-recall-subpotent-drug-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0012-2019
Cite this page
“InvaGen Amlodipine Tablets Recall: Subpotent Drug Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39538-invagen-amlodipine-tablets-recall-subpotent-drug-risk. Based on FDA recall #D-0012-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0012-2019%22&limit=1).
Why it’s dangerous
The tablets may not contain the full amount of active ingredient due to a manufacturing issue. This means the medication might not work as intended, potentially requiring higher doses to achieve the same blood pressure control.
Who’s affected
People prescribed blood pressure medication who have the specific lot number GG80218 from the 1000-count bottles manufactured by Cipla Ltd. in India. Those most at risk are patients relying on this medication for blood pressure control.
How to tell if you have this one
Check for the lot number GG80218 on the bottle label. The product is a 1000-count bottle of 10 mg Amlodipine Besylate tablets, manufactured by Cipla Ltd. in India, with an expiration date of December 2019.
- Brand
InvaGen Pharmaceuticals- Product
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number GG80218 on the bottle label to confirm if the product is affected.
Questions people ask
Why is this medication being recalled?
The medication may not contain the full amount of active ingredient due to a manufacturing issue, making it less effective than labeled.
What should I do if I have the affected product?
The official recall notice does not specify a remedy for this product. Check the product details to see if it has the lot number GG80218.
Is this medication safe to use?
The recall indicates a potential issue with the medication's effectiveness, but it is not unsafe in terms of causing injury. The product may require higher doses for the same effect.
Contact InvaGen Pharmaceuticals
We’ve drafted a message you can send InvaGen Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0012-2019 — InvaGen Pharmaceuticals Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufac Hello, I own a Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India that is covered by recall D-0012-2019 from InvaGen Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
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-0012-2019 (October 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0012-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.