Lupin Recalls Amlodipine 2.5mg Tablets Due to CGMP Deviations
Lupin Pharmaceuticals recalls 43,536 bottles of Amlodipine Besylate 2.5mg tablets due to manufacturing deviations. Check your lot number G304799.
Recall notice
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Contact the company
What happened, in plain English
Lupin Limited is recalling one lot of Amlodipine Besylate Tablets USP, 2.5mg, because the finished products were manufactured using active pharmaceutical ingredients whose intermediates failed specifications. This Class III recall involves 43,536 bottles distributed in the U.S. The record does not specify a remedy or what consumers should do with the medication. Read more at govinfonow.com/recall/43137-lupin-recalls-amlodipine-2-5mg-tablets-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/43137-lupin-recalls-amlodipine-2-5mg-tablets-due-to-cgmp-deviations · Updated October 11, 2026 · FDA enforcement record: FDA #D-1492-2016
Cite this page
“Lupin Recalls Amlodipine 2.5mg Tablets Due to CGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43137-lupin-recalls-amlodipine-2-5mg-tablets-due-to-cgmp-deviations. Based on FDA recall #D-1492-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1492-2016%22&limit=1).
Why it’s dangerous
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations where active pharmaceutical ingredients were used despite their intermediates failing specifications. The record does not explain how this deviation affects the safety or efficacy of the tablets.
Who’s affected
Patients in the United States who were prescribed Amlodipine Besylate Tablets USP, 2.5mg, manufactured by Lupin Limited and sold in 90-count bottles. The specific risk to individuals is not described in the provided record.
How to tell if you have this one
Check your medication bottle for the National Drug Code (NDC) 68180-750-09 and Lot Number G304799 with an expiration date of April 2016. The product is a prescription-only, 90-count bottle manufactured by Lupin Limited in Goa, India, for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland.
- Brand
Lupin Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
US No recalled product was distributed to any foreign consignees by Lupin.- NDC
68180-750-09, 68180-751-09, 68180-751-03, 68180-751-17, 68180-752-09, 68180-752-03, 68180-719-03, 68180-719-09, 68180-720-09, 68180-720-03, 68180-721-03, 68180-721-09, 68180-233-01, 68180-233-02, 68180-455-02, 68180-455-01
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1492-2016 | Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09; Lot #: G304799, Exp. 4/2016 | 43,536 bottles |
| D-1493-2016 | Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03; Lot #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016 | 11,812 bottles |
How this recall unfolded
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1492-2016 (February 19, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1492-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.