Duloxetine Capsules 30mg (Inventia Healthcare) – Capsule Shell Defect (2016)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02
Brand
Inventia Healthcare Private Limited
Lot Codes / Batch Numbers
Batch # 130/16/001, 130/16/002, 130/16/003, Exp. Date 10/17
Products Sold
Batch # 130/16/001, 130/16/002, 130/16/003; Exp. Date 10/17
Inventia Healthcare Private Limited is recalling Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia due to Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026