CLASS III Drug recall · Reported 11 Mar 2015 · FDA Enforcement Report

Quinapril Tablets USP, 5 mg recalled by AVKARE

Avkare is recalling Quinapril Tablets USP, 5 mg, distributed nationwide in the US. The recall was initiated on 27 Feb 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot number: I1404952, Exp. 02/2016

Quantity recalled214 unit dose packs

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-0401-2015
FDA event ID: 70635
Recalling firm: Avkare, Pulaski, TN
Classification: Class III
Status: Terminated
Recall initiated: 27 Feb 2015
FDA classified: 4 Mar 2015
Reported: 11 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

27 Feb 2015	Recall initiated by company
4 Mar 2015	Classified by FDA	+5 days
11 Mar 2015	Published in enforcement report	+7 days

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

Reason for recall

Subpotent Drug

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, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Subpotent Drug

Which lots are affected?

Lot number: I1404952, Exp. 02/2016

Where was it sold?

Nationwide

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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 70635

This product is part of a recall event; the main page for the event is Quinapril Tablets USP, 40 mg recalled by AVKARE.

Reported	Class	Recall	Company	Reason	Where
11 Mar 2015	CLASS III	Quinapril Tablets USP, 40 mg recalled by AVKARE	Avkare	Potency & Assay	Nationwide

More recalls from Avkare

All 62

Reported	Class	Recall	Company	Reason	Where
4 Mar 2026Drug	CLASS II	Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl	AvKARE	Potency & Assay	Nationwide
14 Jan 2026Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin	AvKARE	Potency & Assay	Nationwide
15 Oct 2025Drug	CLASS II	Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	Other	Nationwide

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