CLASS II Drug recall · Reported 22 Jan 2014 · FDA Enforcement Report

Quinapril Tablets USP, 5 mg recalled by Lupin Pharmaceuticals

Lupin Pharmaceuticals is recalling Quinapril Tablets USP, 5 mg, distributed nationwide in the US. The recall was initiated on 17 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 3104879, 3104880, Exp. 10/13, 3110218, 3110219, 3110220 Exp. 12/13

NDC68180-554, 68180-556, 68180-557, 68180-558, 68180-559

UPC0368180559092, 0368180556091

Quantity recalled30,264 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-408-2014
FDA event ID: 66345
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Brand: Quinapril
Manufacturer: Lupin Pharmaceuticals, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 17 Sep 2013
FDA classified: 10 Jan 2014
Reported: 22 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

17 Sep 2013	Recall initiated by company
10 Jan 2014	Classified by FDA	+115 days
22 Jan 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556-09

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval

Which lots are affected?

Lots 3104879, 3104880, Exp. 10/13, 3110218, 3110219, 3110220 Exp. 12/13

Where was it sold?

Nationwide and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 66345

This product is part of a recall event; the main page for the event is Quinapril Tablets USP, 10 mg recalled by Lupin Pharmaceuticals.

Reported	Class	Recall	Company	Reason	Where
22 Jan 2014	CLASS II	Quinapril Tablets USP, 10 mg recalled by Lupin PharmaceuticalsQuinapril	Lupin Pharmaceuticals	Potency & Assay	Nationwide

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Other Quinapril recalls

All 14

Reported	Class	Recall	Company	Reason	Where
28 Dec 2022Drug	CLASS II	Quinapril Tablets USP, 40 mg recalled by Lupin PharmaceuticalsQuinapril	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
28 Dec 2022Drug	CLASS II	Quinapril Tablets USP, 20 mg recalled by Lupin PharmaceuticalsQuinapril	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
2 Nov 2022Drug	CLASS II	Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg recalledQuinapril Hydrochloride/hydrochlorothiazide	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
13 Apr 2022Drug	CLASS II	quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg* recalled	Pfizer	Nitrosamine Impurity	Nationwide
13 Apr 2022Drug	CLASS II	quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg* recalled	Pfizer	Nitrosamine Impurity	Nationwide