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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

LUPIN SOMERSET: Morphine Sulfate Extended-Release Tablets Recalled for Impurity Specifications

Agency Publication Date: April 25, 2019
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Summary

Lupin Somerset is recalling approximately 46,700 bottles of Morphine Sulfate Extended-Release tablets in 15 mg, 30 mg, 60 mg, 100 mg, and 200 mg strengths. The recall was initiated because the medication failed to meet required specifications for impurities and degradation during testing. This prescription drug is used for pain management and was distributed nationwide to five wholesalers and one supermarket chain. If you have this medication, you should consult your healthcare provider or pharmacist regarding the safety of your current supply.

Risk

The tablets failed to meet quality standards for impurities and degradation, which means the medication may contain higher-than-allowed levels of unintended chemical compounds or may have lost potency over time. While the risk is categorized as low, impurities in prescription medications can potentially affect how the drug works or cause unexpected side effects.

What You Should Do

  1. Check your prescription bottle for the following NDC numbers: 43386-540-01 (15 mg), 43386-541-01 (30 mg), 43386-542-01 (60 mg), 43386-543-01 (100 mg), or 43386-544-01 (200 mg).
  2. Verify if your bottle matches the affected lot numbers and expiration dates: Lot S700220 (Exp. 4/30/2019), S700604 (Exp. 7/31/2019), S800326 (Exp. 3/31/2020), S700221 (Exp. 4/30/2019), S700605 (Exp. 7/31/2019), S800232 (Exp. 2/29/2020), S700222 (Exp. 4/30/2019), S800233 (Exp. 2/29/2020), S700223 (Exp. 4/30/2019), S800467 (Exp. 3/31/2020), S700224 (Exp. 4/30/2019), or S800469 (Exp. 3/31/2020).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if a replacement prescription is necessary.
  4. Return any unused or affected medication to your pharmacy to receive a refund.
  5. Contact the manufacturer, Lupin Pharmaceuticals, Inc., for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Morphine Sulfate Extended-Release Tablets (15 mg, 100-count bottle)
Model:
NDC 43386-540-01
Lot Numbers:
S700220 (Exp. Apr 30 2019)
S700604 (Exp. July 31 2019)
S800326 (Exp. Mar 31 2020)
Date Ranges: Apr 30 2019, July 31 2019, Mar 31 2020
Product: Morphine Sulfate Extended-Release Tablets (30 mg, 100-count bottle)
Model:
NDC 43386-541-01
Lot Numbers:
S700221 (Exp. Apr 30 2019)
S700605 (Exp. July 31 2019)
S800232 (Exp. Feb 29 2020)
Date Ranges: Apr 30 2019, July 31 2019, Feb 29 2020
Product: Morphine Sulfate Extended-Release Tablets (60 mg, 100-count bottle)
Model:
NDC 43386-542-01
Lot Numbers:
S700222 (Exp. Apr 30 2019)
S800233 (Exp. Feb 29 2020)
Date Ranges: Apr 30 2019, Feb 29 2020
Product: Morphine Sulfate Extended-Release Tablets (100 mg, 100-count bottle)
Model:
NDC 43386-543-01
Lot Numbers:
S700223 (Exp. Apr 30 2019)
S800467 (Exp. Mar 31 2020)
Date Ranges: Apr 30 2019, Mar 31 2020
Product: Morphine Sulfate Extended-Release Tablets (200 mg, 100-count bottle)
Model:
NDC 43386-544-01
Lot Numbers:
S700224 (Exp. Apr 30 2019)
S800469 (Exp. Mar 31 2020)
Date Ranges: Apr 30 2019, Mar 31 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82581
Status: Resolved
Manufacturer: LUPIN SOMERSET
Sold By: wholesalers; supermarket chain
Manufactured In: United States
Units Affected: 5 products (17,328 bottles; 15,320 bottles; 10,284 bottles; 3,444 bottles; 324 bottles)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.