The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0037-2025·Announced 2024-11-13

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 →

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