FDA Drug recall D-0581-2018
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 088…
- FDA Drug
- Class III
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class III recall of Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 088… by Osmotica Pharmaceutical, citing subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0581-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-02-28 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Osmotica Pharmaceutical |
| Distribution | US |
Product
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
Reason
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Identifiers
| ndc | 13811-709-10 |
|---|---|
| ndc | 13811-706-10 |
| ndc | 13811-707-10 |
| ndc | 13811-708-10 |
| ndc | 13811-710-10 |
| ndc | 13811-710-30 |
| code_info | Lots: 170231B, 170232A, 170233A, 170234A |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Osmotica Pharmaceutical
- Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08…
FDA Drug · Class III · 2017-12-27 · Osmotica Pharmaceutical - Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08…
FDA Drug · Class III · 2017-12-27 · Osmotica Pharmaceutical - Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-coun…
FDA Drug · Class III · 2013-10-09 · Osmotica Pharmaceutical
All Osmotica Pharmaceutical recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0581-2018%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.