Recall archive / FDA drug enforcement
Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Pl... — FDA record D-1174-2022
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 Jun 16, 2022. 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
- Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07
- Reason
- Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
- Classification
- Class II
- Recalling firm
- Macleods Pharma Usa Inc
- Quantity
- 168690 Tablets
- Agency-reported status
- Terminated
- Source record identifier
- D-1174-2022
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 #: BEK2009A Exp: 11/2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed Nationwide and Puerto Rico.
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 13, 2022
- Recall initiation date
- Jun 16, 2022
- Center classification date
- Jul 5, 2022
- Termination date
- Mar 20, 2024
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.