CLASS II ONGOING Drug recall · Reported 12 Mar 2025 · FDA Enforcement Report
Morphine Sulfate Extended-Release Tablets, 100 mg recalled
SUN Pharmaceutical Industries is recalling Morphine Sulfate Extended-Release Tablets, 100 mg, distributed nationwide in the US. The recall was initiated on 6 Feb 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0249-2025
- FDA event ID
- 96242
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Morphine Sulfate
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Feb 2025
- FDA classified
- 3 Mar 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 6 Feb 2025 | Recall initiated by company | |
| 3 Mar 2025 | Classified by FDA | +25 days |
| 12 Mar 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01
Where it was distributed
Nationwide within in the USA.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #: AD16615, Exp. Date 07/2025
Where was it sold?
Nationwide within in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SUN Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Morphine recalls
All 147| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalledMorphine Sulfate | Winder Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets 30 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200 | Hikma Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS III | Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine recalledOpium Tincture Deodorized | Edenbridge Pharmaceuticals | Potency & Assay | Nationwide |