Morphine Sulfate Extended-Release Tablets 15 mg recall
FDA recall D-0036-2025 · initiated Oct 22, 2024
Dr. Reddy's Laboratories, Inc. recalled Morphine Sulfate Extended-Release Tablets 15 mg in Oct 2024 — an FDA Class II recall (D-0036-2025) because Failed Impurities/Degradation Specification.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specification
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
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: 2,040 100-count bottles
Details
- Product
- Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
- Recalling company
- Dr. Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Oct 22, 2024
- FDA report date
- Nov 13, 2024
Frequently asked
- Was Morphine Sulfate Extended-Release Tablets 15 mg recalled?
- Dr. Reddy's Laboratories, Inc. recalled Morphine Sulfate Extended-Release Tablets 15 mg in Oct 2024 — an FDA Class II recall (D-0036-2025) because Failed Impurities/Degradation Specification. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Morphine Sulfate Extended-Release Tablets 15 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0036-2025 was: Failed Impurities/Degradation Specification
- Is a recalled Morphine Sulfate Extended-Release Tablets 15 mg 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 15 mg are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot# FG14062, Exp 10/31/2025. 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-0036-2025.