Quillivant XR — Class III drug recall D-0609-2017
Terminated recall by Pfizer Inc, reported 2017-03-29, distributed nationwide. Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Cel
| Recall number | D-0609-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc, Peapack, NJ, United States |
| Recall initiated | 2017-03-07 |
| Classified | 2017-03-22 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2019-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 9,666 units |
| Reason classes | specification failure |
| NDC | 24478-0190-30 |
| Lot numbers | 01/18, 03216025A |
Product
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), 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 24478-190-30).
Reason for recall
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
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-0609-2017. 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.