Class II · ModerateRecall completed
Captopril Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #s: a) LM10525, Exp 03/15; LM10727, Exp 04/15; LM11519, Exp 08/15; LN10008, Exp 11/15; LN10121, Exp 12/15; LN10887, Exp 04/16; LM11248, Exp 06/16 Lot #s: b) LM10522, Exp 03/15; LM10726, Exp 04/15; LN10007, Exp 11/15; LN10116, Exp 12/15; LN10888, Exp 04/16; LN11281 Exp 07/16
Where it was soldNationwide
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
Failed Tablet/Capsule Specifications: out of specification for thickness.
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 Boulevard, Parsippany, NJ 07054 USA foreign manufacturer
| Distributed by / for | Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA |
| NDC | 64679-902-01 |
Show the full FDA record
| Full product label | Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA |
| Recalling firm | Wockhardt Usa Inc. |
| Distribution | Nationwide |
| Quantity | 93,393 bottles |
| Recall initiated | 2015-03-12 |
| Report date | 2015-05-13 |
| Recall completed | 2017-12-14 |
| Recall number | D-0975-2015 |
| 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.