Bravelle 75 IU — Class III drug recall D-0015-2016
Terminated recall by Ferring Pharmaceuticals Inc, reported 2015-10-21, distributed nationwide. Subpotent Drug
| Recall number | D-0015-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ferring Pharmaceuticals Inc, Parsippany, NJ, United States |
| Recall initiated | 2015-09-09 |
| Classified | 2015-10-14 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2020-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 32,341 vials |
| Reason classes | potency |
| NDC | 55566-8505-06 |
| Lot numbers | 01/16, 04/16, 05/16, K11813A-1, K11813A-2, K11813B-1, K11813C-1, K13031A-1, K13031B-1, K13031B-2 |
Product
Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton (contains 5 single dose vials of Bravelle, 5 single dose vials of 0.9% Sodium Chloride Inj., USP, 2 mL, and 5 Q-Cap Vial Adaptors) , Rx Only, Manufactured for: Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054, By: Ferring Gmbh, Kiel Germany, NDC 55566-8505-6
Reason for recall
Subpotent Drug
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-0015-2016. 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.