Current and Resolved Drug Shortages and Discontinuations Reported to FDA
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Methylphenidate Hydrochloride Tablet, Extended Release
Status: Currently in Shortage
»Date first posted:
07/26/2023
»Therapeutic Categories: Psychiatry
Dr. Reddy's Laboratories, Inc. (Revised 03/18/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 43598-438-01) | Unavailable | Estimated availability TBD | Other |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 43598-439-01) | Unavailable | Estimated availability TBD | Other |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 43598-440-01) | Available | Available to existing customers | |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 43598-441-01) | Unavailable | Estimated availability TBD | Other |
Janssen Pharmaceuticals (Reverified 04/08/2025)
Company Contact Information:
800-JANSSEN (1-800-526-7736) Monday through Friday from 9:00 AM to 8:00 PM ET
800-JANSSEN (1-800-526-7736) Monday through Friday from 9:00 AM to 8:00 PM ET
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Concerta, Tablet, Extended Release, 18 mg (NDC 50458-585-01) | Available | ||
| Concerta, Tablet, Extended Release, 27 mg (NDC 50458-588-01) | Available | ||
| Concerta, Tablet, Extended Release, 36 mg (NDC 50458-586-01) | Available | ||
| Concerta, Tablet, Extended Release, 54 mg (NDC 50458-587-01) | Available |
Lannett Company, Inc. (Reverified 04/03/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 62175-310-37) | Unavailable | Shortage of an active ingredient | |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 62175-311-37) | Unavailable | Shortage of an active ingredient | |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 62175-312-37) | Unavailable | Shortage of an active ingredient | |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 62175-313-37) | Unavailable | Shortage of an active ingredient |
SpecGx LLC (Revised 04/01/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Methylin Er, Tablet, Extended Release, 10 mg (NDC 0406-1445-01) | Available | ||
| Methylin Er, Tablet, Extended Release, 20 mg (NDC 0406-1473-01) | Available | ||
| Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 0406-0127-01) | Limited Availability | Allocation to all customers. Backorder projected in June. | Shortage of an active ingredient |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 0406-0136-01) | Limited Availability | Allocation to all customers. | Shortage of an active ingredient |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 0406-0154-01) | Limited Availability | Allocation to all customers. Backorder projected in April with next release in mid-May. | Shortage of an active ingredient |
Sun Pharmaceutical Industries, Inc. (Revised 04/04/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 57664-606-88) | Unavailable | Currently not marketed | Discontinuation of the manufacture of the drug |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 57664-607-88) | Unavailable | Currently not marketed | Discontinuation of the manufacture of the drug |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 57664-608-88) | Unavailable | Currently not marketed | Discontinuation of the manufacture of the drug |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 57664-609-88) | Unavailable | Currently not marketed | Discontinuation of the manufacture of the drug |
Teva Pharmaceuticals USA, Inc. (Revised 04/07/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Methylphenidate Hydrochloride Extended-Release Tablets, USP CII, Tablet, Extended Release, 18 mg (NDC 62037-725-01) | Available | ||
| Methylphenidate Hydrochloride Extended-Release Tablets, USP CII, Tablet, Extended Release, 27 mg (NDC 62037-734-01) | Limited Availability | Estimated recovery: May 2025 | Demand increase for the drug |
| Methylphenidate Hydrochloride Extended-Release Tablets, USP CII, Tablet, Extended Release, 36 mg (NDC 62037-726-01) | Available | Demand increase for the drug | |
| Methylphenidate Hydrochloride Extended-Release Tablets, USP CII, Tablet, Extended Release, 54 mg (NDC 62037-727-01) | Limited Availability | Estimated recovery: May 2025 | Demand increase for the drug |
Trigen Laboratories, LLC (Reverified 03/18/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 13811-706-10) | Available | Allocation to current contracted customers | Demand increase for the drug |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 13811-707-10) | Available | Allocation to current contracted customers | Demand increase for the drug |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 13811-708-10) | Available | Allocation to current contracted customers | Demand increase for the drug |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 45 mg (NDC 13811-711-30) | Available | ||
| Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 13811-709-10) | Available | Allocation to current contracted customers | Demand increase for the drug |
| Methylphenidate Hydrochloride, Tablet, Extended Release, 63 mg (NDC 13811-700-30) | Available | ||
| Methylphenidate Hydrochloride, Tablet, Extended Release, 72 mg (NDC 13811-710-30) | Available |
Vertical Pharmaceuticals, LLC (Revised 04/03/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Relexxii, Tablet, Extended Release, 18 mg (NDC 68025-095-10) | Limited Availability | Allocation to current contracted customers | Demand increase for the drug |
| Relexxii, Tablet, Extended Release, 27 mg (NDC 68025-096-10) | Limited Availability | Allocation to current contracted customers | Demand increase for the drug |
| Relexxii, Tablet, Extended Release, 36 mg (NDC 68025-097-10) | Limited Availability | Allocation to current contracted customers | Demand increase for the drug |
| Relexxii, Tablet, Extended Release, 45 mg (NDC 68025-088-30) | Limited Availability | Allocation to current contracted customers | Demand increase for the drug |
| Relexxii, Tablet, Extended Release, 54 mg (NDC 68025-098-10) | Limited Availability | Allocation to current contracted customers | Demand increase for the drug |
| Relexxii, Tablet, Extended Release, 63 mg (NDC 68025-089-30) | Limited Availability | Allocation to current contracted customers | Demand increase for the drug |
| Relexxii, Tablet, Extended Release, 72 mg (NDC 68025-084-30) | Limited Availability | Allocation to current contracted customers | Demand increase for the drug |
| Relexxii, Tablet, Extended Release, 18 mg (NDC 68025-095-30) | Limited Availability | Allocation to current contracted customers | Demand increase for the drug |
| Relexxii, Tablet, Extended Release, 27 mg (NDC 68025-096-30) | Limited Availability | Allocation to current contracted customers | Demand increase for the drug |
| Relexxii, Tablet, Extended Release, 36 mg (NDC 68025-097-30) | Limited Availability | Allocation to current contracted customers | Demand increase for the drug |
| Relexxii, Tablet, Extended Release, 54 mg (NDC 68025-098-30) | Limited Availability | Allocation to current contracted customers | Demand increase for the drug |