FDA Drug recall D-0154-2025
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc
- FDA Drug
- Class II
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class II recall of Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc by Macleods Pharmaceuticals, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0154-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-25 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharmaceuticals |
| Distribution | US |
Product
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.
Reason
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 33342-067-07 |
|---|---|
| ndc | 33342-067-44 |
| ndc | 33342-067-12 |
| ndc | 33342-067-11 |
| ndc | 33342-068-07 |
| ndc | 33342-068-44 |
| ndc | 33342-068-12 |
| ndc | 33342-068-11 |
| ndc | 33342-069-07 |
| ndc | 33342-069-44 |
| ndc | 33342-069-12 |
| ndc | 33342-069-11 |
| ndc | 33342-070-07 |
| ndc | 33342-070-15 |
| ndc | 33342-070-12 |
| ndc | 33342-070-44 |
| ndc | 33342-070-11 |
| ndc | 33342-071-07 |
| ndc | 33342-071-15 |
| ndc | 33342-071-12 |
| ndc | 33342-071-44 |
| ndc | 33342-071-11 |
| ndc | 33342-072-07 |
| ndc | 33342-072-15 |
| ndc | 33342-072-12 |
| ndc | 33342-072-44 |
| ndc | 33342-072-11 |
| code_info | Lot# BOB12318A Exp 07/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Macleods Pharmaceuticals
- Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc
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FDA Drug · Class III · 2025-07-16 · Macleods Pharmaceuticals - Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc
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All Macleods Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0154-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.