UnratedDrug recall · FDA · Published October 22, 2024
Dr. Reddy's Morphine Sulfate Tablets Recall: Impurities Risk
Dr. Reddy's recalls 15mg Morphine Sulfate Extended-Release Tablets due to failed impurities specification. Rx-only product manufactured by Mayne Pharma. No remedy specified in official notice.
“Dr. Reddy's Morphine Sulfate Tablets Recall: Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32501-dr-reddy-s-morphine-sulfate-tablets-recall-impurities-risk. Based on FDA recall #D-0036-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0036-2025%22&limit=1).
The FDA announced on Oct. 22, 2024, that Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets due to failed impurity specifications. The agency issued recall number D-0036-2025 for the voluntary Class II action.
How to tell if you have it
Brand: Dr. Reddy's
Product: Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle
Manufacturer: Mayne Pharma
NDC: 51862-185-01
Lot#: FG14062
Expiration Date: 10/31/2025
Quantity: 2,040 bottles
The hazard
The recall addresses failed impurity and degradation specifications in the medication. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has 85 other recalls on record since April 9, 2012. Recent Dr. Reddy's recalls include Varenicline Tablets recalled on Nov. 11, 2025, for subpotent drug risk and Succinylcholine Chloride Injection recalled on Sept. 26, 2025, for stability testing issues. Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets Recall (Aug. 5, 2026), Macleods Olanzapine Tablets 5mg Recall (Aug. 27, 2026), and Sun Pharmaceutical Fexofenadine 180mg Tablets Recall (June 1, 2026).
How to tell if you have this one
Check for the 15mg Morphine Sulfate Extended-Release Tablets (100-count bottles) with NDC 51862-185-01, manufactured by Mayne Pharma in Greenville, NC. The lot number FG14062 expires October 31, 2025.
Brand
Dr. Reddy's
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Identify if you have the specific 15mg Morphine Sulfate Extended-Release Tablets (100-count bottles) with NDC 51862-185-01 manufactured by Mayne Pharma in Greenville, NC.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 22 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0036-2025 (October 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0036-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.