Recall archive / FDA drug enforcement
Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore,... — FDA record D-0148-2024
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 Nov 22, 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
- Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01
- Reason
- Failed Dissolution Specifications
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- N/A
- Agency-reported status
- Terminated
- Source record identifier
- D-0148-2024
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 # M200498, Exp. June 2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed to 3 wholesale/distributor accounts.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 20, 2023
- Recall initiation date
- Nov 22, 2023
- Center classification date
- Dec 13, 2023
- Termination date
- Jul 8, 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.