Morphine Sulfate: 11 recalls on record

Recalled by 1 agency: FDA (11).

First recall on record: May 8, 2013. Most recent: August 26, 2026.

Risk classification: Class I: 1 · Class II: 4 · Class III: 6

Most recent recalls

DateAgencyProduct
August 26, 2026FDAMorphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, …D-0788-2026
December 17, 2025FDAMorphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use …D-0223-2026
March 12, 2025FDAMorphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactur…D-0249-2025
October 6, 2021FDAMorphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius K…D-0856-2021
May 1, 2019FDAMorphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: No…D-1247-2019
May 1, 2019FDAMorphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactur…D-1246-2019
May 1, 2019FDAMorphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufacture…D-1243-2019
May 1, 2019FDAMorphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufacture…D-1245-2019
September 26, 2018FDAMorphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured…D-1214-2018
September 6, 2017FDAMorphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle conta…D-1126-2017
May 8, 2013FDAPreservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx o…D-308-2013

Questions about this brand

How many recalls does Morphine Sulfate have?
Recalert has 11 U.S. recalls on record for Morphine Sulfate, published between May 8, 2013 and August 26, 2026.
What was the most recent Morphine Sulfate recall?
FDA recall D-0788-2026, published August 26, 2026: Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-0…
Which agencies have recalled Morphine Sulfate products?
Morphine Sulfate products appear in recalls from: FDA (11).

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