Methylphenidate Hydrochloride Tablets — Class II drug recall D-0940-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2023-08-02, distributed nationwide. Presence of Foreign Substance: Metal embedded in a tablet.
| Recall number | D-0940-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2023-07-13 |
| Classified | 2023-07-24 |
| Reported by FDA | 2023-08-02 |
| Terminated | 2024-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 7,313 bottles |
| NDC | 57664-0228, 57664-0228-08, 57664-0228-13, 57664-0228-18, 57664-0228-83, 57664-0228-88, 57664-0229, 57664-0229-08, 57664-0229-13, 57664-0229-18, 57664-0229-83, 57664-0229-88, 57664-0230, 57664-0230-08, 57664-0230-13, 57664-0230-18, 57664-0230-83, 57664-0230-88 |
| Lot numbers | AC74459 |
| Expiration dates | 2024-07-31 |
Product
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.
Reason for recall
Presence of Foreign Substance: Metal embedded in a tablet.
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-0940-2023. 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.