FDA Drugs recall ·
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle… recall
- Recall number
- D-0036-2025
- Date
- (initiated October 22, 2024)
- Company / brand
- Dr. Reddy's Laboratories, Inc.
107 College Rd E, Princeton, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,040 100-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Impurities/Degradation Specification
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# FG14062, Exp 10/31/2025
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0036-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.