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Osmotica Pharmaceutical Corp

Osmotica Pharmaceutical Corp Recalls

All product recalls associated with Osmotica Pharmaceutical Corp.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Feb 2018

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–4 of 4 recalls

Methylphenidate Hydrochloride (Osmotica) – Subpotent Dosage (2018)

Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.

Class IIILow

FDAFeb 28, 2018Nationwide• Osmotica Pharmaceutical Corp

Methylphenidate Tablets 54mg (Osmotica) – Subpotent Drug (2017)

Subpotent Drug

Class IIILow

FDADec 18, 2017Nationwide• Osmotica Pharmaceutical Corp

Methylphenidate Tablets 27mg (Osmotica) – Subpotent Drug (2017)

Subpotent Drug

Class III

Low

FDADec 18, 2017Nationwide• Osmotica Pharmaceutical Corp

Venlafaxine Tablets (Osmotica) – Dissolution Specification Failure (2013)

Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.

Class IIILow

FDASep 16, 2013Nationwide• Osmotica Pharmaceutical Corp