Methylphenidate Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution
Trigen Laboratories recalls Methylphenidate Hydrochloride Extended-Release Tablets (36mg) because a batch failed dissolution specifications. Approximately 10,448 bottles were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. Failed dissolution specifications on a prescription medication represents a theoretical risk to drug bioavailability rather than imminent harm. Per the rubric, Class II without hospitalization reports and theoretical hazards score as High.
Plain-English summary
Trigen Laboratories is recalling Methylphenidate Hydrochloride Extended-Release Tablets, USP 36mg (Lot 230159M) because this batch did not meet dissolution specifications.
The recalled product comprises approximately 10,448 100-count bottles with an expiration date of 2/28/2026, distributed nationwide in the United States. Methylphenidate Hydrochloride is a prescription medication used to treat attention-deficit/hyperactivity disorder.
Patients who have the recalled batch should contact their healthcare provider or pharmacist immediately to discuss their medication and whether they require a replacement supply.
More information is available from the FDA's drug recall database at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls, recall number D-0579-2024.
The recalled product
- Product
- METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
- Brand
- METHYLPHENIDATE HYDROCHLORIDE
- Manufacturer
- Trigen Laboratories
- Category
- Drug — ADHD Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 230159M
- Exp Date 2/28/2026
UPCs (2)
- 0313811706109
- 0313811708103
Distribution
Distributed nationwide across the United States.
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