The Recall Desk
ModerateFDA (Drugs)·D-1460-2016·Announced 2016-08-24

Zydus Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failures

Zydus Pharmaceuticals is recalling 223,776 bottles of Venlafaxine Hydrochloride ER 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, 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 defect is a failure in dissolution specifications, which is a quality control issue rather than a direct contamination or labeling error involving high-risk pathogens or allergens.

Plain-English summary

Zydus Pharmaceuticals USA Inc. is recalling 223,776 bottles of Venlafaxine Hydrochloride Extended-Release (ER) Capsules, 150mg. The product is available in 30-count, 90-count, and 1,000-count bottles and is distributed nationwide. The recall was initiated because retained samples of the medication failed to meet dissolution specifications.

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, New Jersey. The recall covers specific lots with expiration dates ranging from September 2017 to November 2017.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the pharmacy or point of purchase 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
Affected units
223,776

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 (20)

  • Lot #: a) MR10518
  • Exp. 9/2017
  • MR11051
  • MR11052
  • MR11053
  • MR11054
  • Exp. 10/2017
  • MR11403
  • Exp. 11/2017. Lot #: b) MR10197
  • MR10195
  • Exp. 09/2017
  • MR11482
  • Exp.10/2017
  • MR11479
  • MR11480
  • MR11481
  • MR11483
  • MR11665 Exp. 11/2017. Lot #: c) MR10404
  • MR10406
  • MR10521

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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