FDA Drug recall D-0940-2023
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ…
- FDA Drug
- Class II
- terminated
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class II recall of Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ… by Sun Pharmaceutical Industries, citing presence of Foreign Substance: Metal embedded in a tablet.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0940-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-07-13 |
| Published | 2023-08-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Presence of Foreign Substance: Metal embedded in a tablet.
Identifiers
| ndc | 57664-228-83 |
|---|---|
| ndc | 57664-228-88 |
| ndc | 57664-228-08 |
| ndc | 57664-228-13 |
| ndc | 57664-228-18 |
| ndc | 57664-229-83 |
| ndc | 57664-229-88 |
| ndc | 57664-229-08 |
| ndc | 57664-229-13 |
| ndc | 57664-229-18 |
| ndc | 57664-230-83 |
| ndc | 57664-230-88 |
| ndc | 57664-230-08 |
| ndc | 57664-230-13 |
| ndc | 57664-230-18 |
| code_info | Lot AC74459, Exp 07/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0940-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.