Famotodine Tablets — Class II drug recall D-1265-2015
Terminated recall by Wockhardt Usa Inc., reported 2015-07-29, distributed nationwide. CGMP Deviations: Firm did not adequately investigate customer complaints.
| Recall number | D-1265-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wockhardt Usa Inc., Parsippany, NJ, United States |
| Recall initiated | 2015-04-22 |
| Classified | 2015-07-17 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2018-05-09 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 64679-0936-01, 64679-0936-02, 64679-0936-03 |
| Lot numbers | LM10685, LM10687, LM10691, LM10692, LM10707, LM10708, LM10709, LM10719, LM10721, LM10735, LM10741, LM10743, LM10827, LM10828, LM10859, LM10860, LM10861, LM10862, LM10869, LM10911, LM10912, LM11158, LM11200, LM11205, LM11206, LM11239, LM11679, LM11680, LM11822, LM11993, LM12039, LN10114, LN10115, LN10426, LN10427, LN10428, LN10435, LN10463, LN10464, LN10465 and 26 more |
| Expiration dates | 2015-04-30, 2015-05-31, 2015-07-31, 2015-09-30, 2015-10-31, 2015-12-31, 2016-01-31, 2016-03-31, 2016-05-31, 2016-06-30, 2016-07-31, 2016-08-31, 2016-09-30 |
Product
Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Reason for recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1265-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.