This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.
Who can recall a drug?
The manufacturer can voluntarily recall their medication or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled four lots of three strengths of lisinopril tablets: 2.5 mg, 10 mg, and 20mg.
Why are the lisinopril tablets recalled?
The recall was initiated following an inspection in March 2015. It was determined that more extensive research into previous complaints about the affected tablet strengths was needed. There have been several recalls of other Wockhardt products over the past couple of years, including metoprolol, another heart medication.
When was the recall initiated?
The affected lots of lisinopril tablets were recalled by the manufacturer on July 17, 2015.
How long have the affected products been in pharmacies?
The recalled lots of lisinopril 2.5 mg, 10 mg, and 20 mg tablets started shipping about three years ago, on July 20, 2012. The recalled lot for the 2.5 mg strength has actually already expired, so it’s less likely that you would still have it on hand. The others are due to expire by January 2016.
Are patients who have taken this medication being notified?
No. This is a class II recall, which means that notification of patients is not necessary unless your doctor believes it may have an effect on your health.
If you have concerns that your prescription may be affected, contact your doctor or your pharmacist.
Which products were affected?
In this recall, four lots and three strengths were affected.
Drug: lisinopril 2.5mg tablets, 100-count bottle
Lot: DM10573, expiration 04/2015
National Drug Code (NDC): 64679-927-01
Drug: lisinopril 10mg tablets, 1000-count bottle
Lots: DM13052 and DM13053, expiration 09/2015
National Drug Code (NDC): 64679-929-06
Drug: lisinopril 20mg tablets, 1000-count bottle
Lots: DN10485, expiration 01/2016
National Drug Code (NDC): 64679-941-06