The Recall Desk
ModerateFDA (Drugs)·D-0236-2015·Announced 2014-11-12

Sun Pharma Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures

Sun Pharma Global Inc. is recalling specific batches of Venlafaxine Hydrochloride Extended-Release Tablets because they failed dissolution specifications and a 12-month stability time point.

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 recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The specific failure of dissolution and stability specifications represents a quality defect that may affect efficacy but is not associated with reported serious injury or death in the source text.

Plain-English summary

Sun Pharma Global Inc. is recalling 68,194 bottles of Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, in 30-count and 90-count sizes. The affected products were manufactured for Sun Pharma Global Inc. in Dubai, United Arab Emirates, by Sun Pharmaceutical Industries Limited in Halol, India. The recall covers batches JKM3855A, JKM3855B, JKM7265A, and JKM7265B, which were distributed nationwide and in Puerto Rico.

The recall was initiated because the affected tablets failed to meet dissolution specifications and a 12-month stability time point. These quality control failures mean the medication may not release the active ingredient as intended or may not remain stable over its shelf life.

Consumers and healthcare providers should stop using the affected products and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India
Manufacturer
Sun Pharma Global Inc.
Category
Drug — Antidepressant
Hazard
Affected units
68,194

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same hazard · dissolution failure

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