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Drug recall · FDA · Published July 19, 2016

Zydus Pharmaceuticals USA Inc recalls Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC

Failed Dissolution Specifications: out of specification dissolution results in retained samples

🇺🇸 FDA recall #D-1460-2016DrugZydus Pharmaceuticals (USA) Inc ›
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Recalling firmZydus Pharmaceuticals USA Inc73 Route 31 N, N/A · Pennington, NJ 08534-3601
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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Source Page by GovInfoNow · govinfonow.com/recall/42540-zydus-pharmaceuticals-usa-inc-recalls-venlafaxine-hcl-er-capsule-usp · Recall date July 19, 2016 · FDA enforcement record: FDA #D-1460-2016

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“Zydus Pharmaceuticals USA Inc recalls Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC.” GovInfoNow, recall dated July 19, 2016. https://govinfonow.com/recall/42540-zydus-pharmaceuticals-usa-inc-recalls-venlafaxine-hcl-er-capsule-usp. Based on FDA recall #D-1460-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1460-2016%22&limit=1).

How to tell if you have this one

  • Brand
    Zydus Pharmaceuticals (USA) Inc
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide
  • NDC
    68382-034-06, 68382-034-16, 68382-034-10, 68382-035-06, 68382-035-16, 68382-035-10, 68382-036-06, 68382-036-16, 68382-036-10
Recall numberProduct, codes & lotsQuantity
D-1460-2016Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.; 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, Exp. 09/2017; MR10744, MR11055, MR11228, MR11287, MR11285, MR11288, MR11289, MR11286, Exp.10/2017; MR11567, Exp.11/2017.223,776 bottles
D-1461-2016Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.; 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.11/2017N/A
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Contact Zydus Pharmaceuticals (USA) Inc

We’ve drafted a message you can send Zydus Pharmaceuticals (USA) Inc to request your refund or repair — edit it as you like.

Subject: Recall D-1460-2016 — Zydus Pharmaceuticals (USA) Inc Zydus Pharmaceuticals USA Inc recalls Venlafaxine HCL ER Capsule US

Hello,

I own a Zydus Pharmaceuticals USA Inc recalls Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC that is covered by recall D-1460-2016 from Zydus Pharmaceuticals (USA) Inc.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1460-2016 (July 19, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1460-2016 to see it in context.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA