The Recall Desk
ModerateFDA (Drugs)·D-1461-2016·Announced 2016-08-24

Zydus Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failures

Zydus Pharmaceuticals USA Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules because retained samples failed dissolution specifications.

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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Zydus Pharmaceuticals USA Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules, 75mg. The recall was initiated because retained samples of the product yielded out-of-specification dissolution results. The affected product is a prescription-only medication manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ.

The recall covers 30-count, 90-count, and 1000-count bottles with NDC codes 68382-035-06, 68382-035-16, and 68382-035-10, respectively. Specific lot numbers and expiration dates are listed in the official recall notice. The distribution pattern for the affected product is nationwide.

Consumers and healthcare providers should check their inventory for the specific lot numbers and NDC codes listed in the recall. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they are currently taking the affected medication.

The recalled product

Product
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
Brand
VENLAFAXINE HYDROCHLORIDE
Manufacturer
Zydus Pharmaceuticals USA Inc
Category
Drug — Prescription 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 (11)

  • Lot #: a) MS1217
  • MS1218
  • Exp.12/2017. Lot #: b) MS1215
  • Exp.12/2017 Lot #: c) MR11150
  • MR11151
  • MR11854
  • Exp. 10/2017
  • MR11798
  • MR11799
  • MS1214
  • Exp.11/2017

UPCs (3)

  • 0368382034106
  • 0368382035103
  • 0368382036100

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Zydus Pharmaceuticals USA Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · VENLAFAXINE HYDROCHLORIDE

Same manufacturer · Zydus Pharmaceuticals USA Inc

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Same hazard · dissolution failure

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