Osmotica Recalls Subpotent Methylphenidate Hydrochloride Extended-Release Tablets
Osmotica Pharmaceutical Corp is recalling specific lots of Methylphenidate Hydrochloride Extended-Release Tablets because some 100-count bottles contain one 27 mg tablet instead of 36 mg.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a minor potency deviation (one 27 mg tablet in a 100-count bottle of 36 mg tablets), which fits the criteria for moderate severity involving minor labeling or potency errors without reported serious injury.
Plain-English summary
Osmotica Pharmaceutical Corp is recalling 19,664 100-count bottles of Methylphenidate Hydrochloride Extended-Release Tablets, USP, 36 mg. The product is manufactured by Trigen Laboratories, LLC and distributed nationwide in the USA. The recall involves lots 170231B, 170232A, 170233A, and 170234A.
The recall was initiated because some 100-count product bottles labeled as containing 36 mg tablets were found to contain one 27 mg Methylphenidate Hydrochloride Extended-Release Tablet. This is classified as a subpotent drug issue.
Consumers and healthcare providers should check their inventory for the affected NDC 13811-708-10 and the specific lot numbers listed above. If the product is found, it should be returned to the pharmacy or supplier for credit.
The recalled product
- Product
- METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
- Brand
- METHYLPHENIDATE HYDROCHLORIDE
- Manufacturer
- Osmotica Pharmaceutical Corp
- Category
- Drug — Prescription Drug
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 (4)
- Lots: 170231B
- 170232A
- 170233A
- 170234A
UPCs (2)
- 0313811706109
- 0313811708103
Distribution
Distributed nationwide across the United States.
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