Morphine Sulfate Extended-Release Tablets — Class III drug recall D-1214-2018
Terminated recall by LUPIN SOMERSET, reported 2018-09-26, distributed nationwide. Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due
| Recall number | D-1214-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LUPIN SOMERSET, Somerset, NJ, United States |
| Recall initiated | 2018-08-23 |
| Classified | 2018-09-27 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2022-10-14 |
| Distributed | Nationwide (US) |
| Quantity | 4,716 bottles |
| Reason classes | specification failure |
| NDC | 43386-0540, 43386-0540-01, 43386-0540-05, 43386-0541, 43386-0541-01, 43386-0541-05, 43386-0542, 43386-0542-01, 43386-0542-05, 43386-0543, 43386-0543-01, 43386-0543-05, 43386-0544, 43386-0544-01, 43386-0544-05 |
| Lot numbers | 2/20, S800232 |
Product
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01
Reason for recall
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1214-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.