Morphine Sulfate Extended-Release Tablets Recalled for Failed Impurities Specification
Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 30 mg (Lot FG13996) nationwide due to failed impurities and degradation specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a prescription opioid product with failed quality specifications. No illnesses or injuries have been reported in the source material, but morphine products present inherent risk of harm if efficacy or safety are compromised by degradation.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Morphine Sulfate Extended-Release Tablets 30 mg because the product failed to meet required specifications for impurities and degradation. The recall encompasses 532 bottles (100-count size) distributed nationwide. The affected medication is identified by Lot Number FG13996, which expires 09/30/2025.
Patients currently taking this medication should consult their healthcare provider or pharmacist before making any changes to their medication regimen. Those who may have received the affected product should contact their pharmacy or physician for guidance on replacement or alternative treatment options.
The recalled product
- Product
- Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Opioid
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# FG13996
- Exp 09/30/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Dr. Reddy's Laboratories, Inc.
See all →- ModerateVarenicline tablets recalled after an assay value fell below specification
FDA (Drugs) · 2025-12-17
- Moderate
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- SevereLevetiracetam Injection Label Mismatch Nationwide Recall
FDA (Drugs) · 2025-04-23
- ModerateFDA Recalls JAVYGTOR Tablets Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2024-12-18
Same hazard · impurities
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMethohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide
FDA (Drugs) · 2026-07-15
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08