FDA Drugs recall ·
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg recall
- Recall number
- D-0310-2025
- Date
- (initiated March 21, 2025)
- Company / brand
- Zydus Pharmaceuticals (USA) Inc
73 Route 31 N, Pennington, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 13,128 100-Count Bottles
- Hazard tags
- Foreign material
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.
Why was it recalled?
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: M314265, Exp.: 31 October 2025.
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0310-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.