Recall archive / FDA drug enforcement
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury N... — FDA record D-0914-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
- Reason
- Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 8,880 30-count bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0914-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot HAC3339A, Expires 07/2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed nationwide in the USA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 19, 2023
- Recall initiation date
- Jul 10, 2023
- Center classification date
- Jul 11, 2023
- Termination date
- Dec 18, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.