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Drug recall · FDA · Published February 19, 2016

Lupin Limited recalls Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

🇺🇸 FDA recall #D-1492-2016DrugLupin Limited ›
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Recalling firmLupin Limited15-B, Phase 1A, Verna Industrial Area · Verna, Salcette, Goa, N/A
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.

Source Page by GovInfoNow · govinfonow.com/recall/43137-lupin-limited-recalls-amlodipine-besylate-tablets-usp-2-5mg-90 · Recall date February 19, 2016 · FDA enforcement record: FDA #D-1492-2016

Cite this page

“Lupin Limited recalls Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc..” GovInfoNow, recall dated February 19, 2016. https://govinfonow.com/recall/43137-lupin-limited-recalls-amlodipine-besylate-tablets-usp-2-5mg-90. Based on FDA recall #D-1492-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1492-2016%22&limit=1).

How to tell if you have this one

  • Brand
    Lupin Limited
  • Category
    Drug
FDA recall event · 2 products

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 numberProduct, codes & lotsQuantity
D-1492-2016Amlodipine 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. 4/201643,536 bottles
D-1493-2016Amlodipine 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. 4/201611,812 bottles
Take action

Contact Lupin Limited

We’ve drafted a message you can send Lupin Limited to request your refund or repair — edit it as you like.

✉️ Open in email
Subject: Recall D-1492-2016 — Lupin Limited Lupin Limited recalls Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx on

Hello,

I own a Lupin Limited recalls Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. that is covered by recall D-1492-2016 from Lupin Limited.

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.

Similar recalls

Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,
Lupin Pharmaceuticals Inc. · 90% matchLupin Pharmaceuticals Inc. recalls Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx
Lupin Pharmaceuticals Inc. · 89% matchLupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC
Lupin Pharmaceuticals Inc. · 87% matchLupin Pharmaceuticals Inc. recalls Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.
Lupin Pharmaceuticals · 86% matchLupin Limited recalls Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.,
Lupin Limited · 86% match

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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.
  • 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA