Fluconazole Oral Suspension — Class III drug recall D-747-2014
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2014-01-29, distributed nationwide. Failed Stability Specifications: this product is below specification for preservative content.
| Recall number | D-747-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2013-11-14 |
| Classified | 2014-01-17 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 234,242 bottles |
| Reason classes | specification failure |
| NDC | 00093-5414-95 |
| Lot numbers | V10316, V10317, V10320, V10321, V20086, V20087, V20089, V20093, V20094, V20118, V20119, V20147, V20148, V20152, V20154, V20155, V20180, V20181, V20182, V20203, V20204, V20233, V20234, V20273, V20274, V20275, V20293, V20294, V20321, V20322, V20323, V20324, V20325, V20326, V20327, V20369, V20370, V20410, V20411, V20412 and 13 more |
Product
Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95.
Reason for recall
Failed Stability Specifications: this product is below specification for preservative content.
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-747-2014. 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.