CLASS III Drug recall · Reported 12 Apr 2017 · FDA Enforcement Report
Quinapril Tablets USP 5 mg, Lupin Pharmaceuticals, Inc. recalled
Lupin Pharmaceuticals is recalling Quinapril Tablets USP 5 mg, Lupin Pharmaceuticals, Inc., Baltimore, MD, distributed nationwide in the US. The recall was initiated on 7 Dec 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-0650-2017
- FDA event ID
- 76924
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Quinapril
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Dec 2015
- FDA classified
- 6 Apr 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 7 Dec 2015 | Recall initiated by company | |
| 6 Apr 2017 | Classified by FDA | +486 days |
| 12 Apr 2017 | Published in enforcement report | +6 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; Impurity A
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 bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
Where it was distributed
Nationwide
Questions about this recall
Is Quinapril Tablets USP 5 mg, Lupin Pharmaceuticals, Inc., Baltimore, MD recalled?
Yes. Lupin Pharmaceuticals recalled Quinapril Tablets USP 5 mg, Lupin Pharmaceuticals, Inc., Baltimore, MD on 7 Dec 2015. The recall is Class III and its status is Terminated. Recall number D-0650-2017.
Why was it recalled?
Failed Impurities/Degradation Specifications; Impurity A
Which lots are affected?
Batch number G303703, exp 3/2016
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.
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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 recalled by AVKARE | AVKARE | Potency & Assay | Nationwide |
| Drug | CLASS III | Quinapril Tablets USP, 40 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 |