Morphine Sulfate Extended-Release Tablets — Class III drug recall D-1244-2019

Terminated recall by LUPIN SOMERSET, reported 2019-05-01, distributed nationwide. Failed Impurities/Degradation Specifications

Recall number	`D-1244-2019`
Product type	Drug
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	LUPIN SOMERSET, Somerset, NJ, United States
Recall initiated	2019-04-10
Classified	2019-04-25
Reported by FDA	2019-05-01
Terminated	2022-10-14
Distributed	Nationwide (US)
Quantity	15,320 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	`S700221`, `S700605`, `S800232`
Expiration dates	`2019-04-30`, `2019-07-31`, `2020-02-29`

Product

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, 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

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-1244-2019. 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.