Class II · ModerateRecall completed
Lidocaine 2.5% and Prilocaine 2.5% Cream
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: a) 16291, Exp. Date 01/2024;16469, Exp. Date 02/2024; b)16255, Exp. Date 11/2022; 16256, 16412 Exp. Date 02/2024; 16257, 16258, Exp. Date12/2022; 16505, 6506, Exp. Date 03/2024; 16627,16786, 16787,16820, Exp. Date 04/2024.
Where it was soldNationwide within the United States
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
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 byTeligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA
| Distributed by / for | Actavis Pharma, Inc., Parsippany, NJ 07054, USA |
| NDC | 0591-2070-72 |
Show the full FDA record
| Full product label | Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA |
| Recalling firm | Teva Pharmaceuticals USA Inc |
| Distribution | Nationwide within the United States |
| Quantity | 353964 units |
| Recall initiated | 2022-04-15 |
| Report date | 2022-05-04 |
| Recall completed | 2023-05-25 |
| Recall number | D-0794-2022 |
| 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.