Quillivant XR methylphenidate HCl — Class III drug recall D-1163-2017
Terminated recall by Pfizer Inc., reported 2017-09-27, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-1163-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2017-08-04 |
| Classified | 2017-09-15 |
| Reported by FDA | 2017-09-27 |
| Terminated | 2019-04-11 |
| Distributed | Nationwide (US) |
| Quantity | 14,712 bottles |
| Reason classes | specification failure |
| NDC | 24478-0200-20 |
| Lot numbers | 03216048A, 05/18 |
Product
Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-20.
Reason for recall
Failed Dissolution Specifications
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-1163-2017. 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.