CLASS III Drug recall · Reported 11 Mar 2015 · FDA Enforcement Report
Quinapril Tablets USP, 40 mg recalled by AVKARE
AVKARE is recalling Quinapril Tablets USP, 40 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
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-0402-2015
- 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, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15
Where it was distributed
Nationwide
Questions about this recall
Is Quinapril Tablets USP, 40 mg recalled?
Yes. AVKARE recalled Quinapril Tablets USP, 40 mg on 27 Feb 2015. The recall is Class III and its status is Terminated. Recall number D-0402-2015.
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot number: I1407932, 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AVKARE
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
Other Quinapril recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Quinapril Tablets USP, 40 mg recalled by Lupin PharmaceuticalsQuinapril | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Quinapril Tablets USP, 20 mg recalled by Lupin PharmaceuticalsQuinapril | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Quinapril Tablets USP 5 mg, Lupin Pharmaceuticals, Inc. recalledQuinapril | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Quinapril Tablets USP, 5 mg recalled by AVKARE | AVKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Quinapril Tablets USP, 5 mg recalled by Lupin PharmaceuticalsQuinapril | Lupin Pharmaceuticals | Potency & Assay | Nationwide |