CLASS II Drug recall · Reported 12 Nov 2014 · FDA Enforcement Report
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg bottles recalled
Sun Pharma Global is recalling Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg bottles, distributed nationwide in the US. The recall was initiated on 26 Sep 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0236-2015
- FDA event ID
- 69370
- Recalling firm
- Sun Pharma Global, Dubai, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Sep 2014
- FDA classified
- 4 Nov 2014
- Reported
- 12 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 26 Sep 2014 | Recall initiated by company | |
| 4 Nov 2014 | Classified by FDA | +39 days |
| 12 Nov 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications; 12 month stability time point
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications; 12 month stability time point
Which lots are affected?
Batch Number: JKM3855A Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM3855B Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM7265A Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015 Batch Number: JKM7265B Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Venlafaxine recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Venlafaxine Tablets, USP, 75 mg recalled by Zydus Pharmaceuticals (USA)Venlafaxine | Zydus Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS III | Venlafaxine Extended-Release Tablets, 150mg recalled by Appco PharmaVenlafaxine | Appco Pharma | Other | Nationwide |
| Drug | CLASS II | Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg recalledVenlafaxine Hydrochloride | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Venlafaxine Hydrochloride, extended-release capsules recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Venlafaxine Tablets, USP 50 mg* recalled | SUN Pharmaceutical Industries | Other | TN |