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Drug FDA Class II Terminated Failed specifications

Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534

Zydus Pharmaceuticals (USA) Inc Published Jul 31, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Zydus Pharmaceuticals (USA) Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.

Hazards

Failed Dissolution · primary

Affected products (1)

Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534

VENLAFAXINE HYDROCHLORIDE · a) 13,128 bottles; b) 252 bottles

NDC: 68382-034, 68382-035, 68382-036, 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
Code info: Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 21, 2024
  2. Published
    Jul 31, 2024
  3. Terminated
    Aug 6, 2025
Recall number
D-0617-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.