Class II · ModerateRecall completed
Lisinopril Tablets USP
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberA) Lot #: DM11003, Expiry: 4/30/2015; Lot #: DM11094, Expiry: 4/30/2015; Lot #: DM11689, Expiry: 6/30/2015; Lot #: DM11873, Expiry: 6/30/2015; Lot #: DM11874, Expiry: 6/30/2015; Lot #: DM12402, Expiry: 8/31/2015; Lot #: DM12412, Expiry: 8/31/2015; Lot #: DM13440, Expiry: 11/30/2015; Lot #: DN10689, Expiry: 1/31/2016; Lot #: DN10693, Expiry: 1/31/2016. B) Lot #: DM11095, Expiry: 4/30/2015; Lot #: DM11688, Expiry: 6/30/2015; Lot #: DM11860, Expiry: 6/30/2015; Lot #: DM12413, Expiry: 8/31/2015; Lot #: DN10692, Expiry: 1/31/2016.
Where it was soldU.S. Nationwide including Puerto Rico.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Firm did not adequately investigate customer complaints.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byWockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA foreign manufacturer
| Distributed by / for | Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA |
| NDC | 64679-953-01 |
Show the full FDA record
| Full product label | Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. |
| Recalling firm | Wockhardt Usa Inc. |
| Distribution | U.S. Nationwide including Puerto Rico. |
| Quantity | A) 63,203 Bottles and B) 6,094 Bottles. |
| Recall initiated | 2015-04-22 |
| Report date | 2015-07-29 |
| Recall completed | 2018-05-09 |
| Recall number | D-1260-2015 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Parsippany NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.