CLASS III Drug recall · Reported 5 Jun 2013 · FDA Enforcement Report
Lisinopril Tablets, USP, 30 mg recalled by Aurobindo Pharma USA
Aurobindo Pharma USA is recalling Lisinopril Tablets, USP, 30 mg, distributed nationwide in the US. The recall was initiated on 9 Apr 2013 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-498-2013
- FDA event ID
- 65071
- Recalling firm
- Aurobindo Pharma USA, Plainsboro, NJ
- Brand
- Lisinopril
- Manufacturer
- Aurobindo Pharma Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Apr 2013
- FDA classified
- 30 May 2013
- Reported
- 5 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 9 Apr 2013 | Recall initiated by company | |
| 30 May 2013 | Classified by FDA | +51 days |
| 5 Jun 2013 | 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
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Product as listed by the FDA
Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Which lots are affected?
Lot KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13
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.
More recalls from Aurobindo Pharma USA
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
Other Lisinopril recalls
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg recalledLisinopril And Hydrochlorothiazide | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Lisinopril Tablets, USP 10 mg recalled by Evaric PharmaceuticalsLisinopril | Evaric Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg recalledLisinopril And Hydrochlorothiazide | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lisinopril Tablets USP, 10 mg recalled by Lupin PharmaceuticalsLisinopril | Lupin Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Lisinopril Tablets USP, 10 mg recalled by Lupin Pharmaceuticals | Lupin Pharmaceuticals | Other | Nationwide |