Morphine Sulfate Extended-Release Tablets recall
FDA recall D-0249-2025 · initiated Feb 6, 2025
SUN PHARMACEUTICAL INDUSTRIES INC recalled Morphine Sulfate Extended-Release Tablets in Feb 2025 — an FDA Class II recall (D-0249-2025) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 9840 bottles
Details
- Product
- 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
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within in the USA.
- Initiated
- Feb 6, 2025
- FDA report date
- Mar 12, 2025
Frequently asked
- Was Morphine Sulfate Extended-Release Tablets recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Morphine Sulfate Extended-Release Tablets in Feb 2025 — an FDA Class II recall (D-0249-2025) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Morphine Sulfate Extended-Release Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0249-2025 was: Failed Dissolution Specifications
- Is a recalled Morphine Sulfate Extended-Release Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Morphine Sulfate Extended-Release Tablets are affected?
- Distributed: Nationwide within in the USA.. The recall covers these lots — Lot #: AD16615, Exp. Date 07/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0249-2025.