LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.
Lupin Somerset recalls 60mg Morphine Sulfate Extended-Release Tablets due to failed impurities and degradation specifications. Rx-only bottles with specific NDC and lot numbers affected.
Recall notice
Failed Impurities/Degradation Specifications
Contact the company & request your remedy
What happened, in plain English
Lupin Somerset is recalling 60 mg Morphine Sulfate Extended-Release Tablets (100-count bottles) because they failed impurities and degradation tests. This could pose a risk to patients using these medications. Read more at govinfonow.com/recall/38939-lupin-somerset-morphine-sulfate-tablets-recall-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38939-lupin-somerset-morphine-sulfate-tablets-recall-impurities-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1245-2019
Cite this page
“Lupin Somerset Morphine Sulfate Tablets Recall: Impurities Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38939-lupin-somerset-morphine-sulfate-tablets-recall-impurities-risk. Based on FDA recall #D-1245-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1245-2019%22&limit=1).
Why it’s dangerous
The tablets failed impurities and degradation specifications, meaning they may contain harmful substances or break down in a way that could affect safety. This could lead to unexpected side effects or reduced effectiveness of the medication.
Who’s affected
Prescription patients who have the specific 60 mg Morphine Sulfate Extended-Release Tablets with NDC 43386-542-01 and lots S700222 (expiring April 2019) or S800233 (expiring February 2020) are affected. Patients using these tablets for pain management are most at risk.
How to tell if you have this one
Check for the product name 'Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles' with NDC 43386-542-01 and lot numbers S700222 (expiring April 2019) or S800233 (expiring February 2020).
- Brand
Lupin Somerset- Category
Drug
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.- NDC
43386-540-01, 43386-540-05, 43386-541-01, 43386-541-05, 43386-542-01, 43386-542-05, 43386-543-01, 43386-543-05, 43386-544-01, 43386-544-05
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1243-2019 | Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01; Lot#: S700220, Exp. Apr 30 2019; S700604, Exp. July 31 2019; S800326, Exp. Mar 31 2020 | 17,328 bottles |
| D-1244-2019 | 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; Lot#: S700221, Exp. Apr 30 2019; S700605, Exp. July 31 2019; S800232, Exp. Feb 29 2020. | 15,320 bottles |
| D-1245-2019 | Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-01; Lot#: S700222 Exp. Apr 30 2019 ; S800233 Exp, Feb 29 2020 | 10,284 bottles |
| D-1246-2019 | Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-543-01; Lot#: S700223 Exp. Apr 30 2019; S800467, Exp. Mar 31 2020. | 3,444 bottles |
| D-1247-2019 | Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01; Lot#: S700224 Exp. Apr 30 2019; S800469 Exp. Mar 31 2020 | 324 bottles |
What to do — step by step
Check Product Details
Verify the NDC number 43386-542-01 and lot numbers S700222 or S800233 on the bottle.
Questions people ask
What is the specific product being recalled?
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles with NDC 43386-542-01 and lot numbers S700222 (expiring April 2019) or S800233 (expiring February 2020).
How can I tell if I have the recalled product?
Check the NDC number 43386-542-01 and lot numbers S700222 or S800233 on the bottle label.
What should I do if I have the recalled product?
The recall record does not specify a remedy, so contact Lupin Somerset directly for guidance.
Contact Lupin Somerset
We’ve drafted a message you can send Lupin Somerset to request your refund or repair — edit it as you like.
Subject: Recall D-1245-2019 — Lupin Somerset Lupin Somerset Hello, I own a Lupin Somerset that is covered by recall D-1245-2019 from Lupin Somerset. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1245-2019 (April 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1245-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.