Agency classClass IIIOur severity:Low FDA (Drugs)·D-1067-2013·Announced 2013-10-09

Osmotica Recalls Venlafaxine Extended Release Tablets for Dissolution Failure

Osmotica Pharmaceutical Corp. is recalling specific lots of Venlafaxine extended release tablets because they failed to meet dissolution specifications at 18 months.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The issue is a technical specification failure (dissolution) rather than a direct safety hazard like contamination or mislabeling.

Plain-English summary

Osmotica Pharmaceutical Corp. is recalling 57,857 bottles of Venlafaxine (Venlafaxine Hydrochloride) extended release tablets, 225 mg. The affected products are packaged in 30-count bottles (NDC 0131-3268-32) and 90-count bottles (NDC 0131-3268-46). These prescription-only medications were manufactured by Kremers Urban Pharmaceuticals Inc. for Osmotica Pharmaceutical Corp. in Wilmington, NC, and were distributed nationwide.

The recall was initiated because the product failed to meet dissolution specifications at the 12-hour time point at 18 months of product shelf life. The affected lot numbers are 58975, 58976, 58977, and 65165 for the 30-count bottles, and 58973, 58974, and 65131 for the 90-count bottles. All affected lots have an expiration date of 01/14.

Consumers and healthcare providers should check their inventory for these specific NDCs and lot numbers. If the product matches the recalled description, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider regarding alternative treatment options if they are currently using the recalled medication.

The recalled product

Product: Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington…
Manufacturer: Osmotica Pharmaceutical Corp
Category: Drug — Antidepressant
Hazard: dissolution-failure
Affected units: 57,857

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 (9)

Lot #: a) 58975
58976
58977
65165
Exp 01/14
b) 58973
58974
65131
Exp: 01/14

Distribution

Distributed nationwide across the United States.

Same manufacturer · Osmotica Pharmaceutical Corp

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Same hazard · dissolution failure