Morphine Sulfate recalls: 12 FDA reports
Recalls involving Morphine Sulfate. What was wrong with each batch, and how the FDA graded the risk.
12Reports
0Class I
3Ongoing
2025-12-17Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By
D-0223-2026 · Class III · reported 2025-12-17 · Ongoing
- Why it was recalled
- Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
- Product
- Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
- Where it went
- U.S. Nationwide
- How much
- 3,528 30 mL Bottles
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratori
D-0249-2025 · Class II · reported 2025-03-12 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01
- Where it went
- Nationwide within in the USA.
- How much
- 9840 bottles
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma B
D-0392-2024 · Class II · reported 2024-03-27 · Ongoing
- Why it was recalled
- The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
- Product
- Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
- Where it went
- Nationwide within the United States
- How much
- 22,644 ampuls
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL
D-0856-2021 · Class II · reported 2021-10-06 · Terminated
- Why it was recalled
- Defective container: Cracked vials leading to lack of sterility assurance
- Product
- Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper
- Where it went
- U.S.A. Nationwide
- How much
- 963000 vials
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laborator
D-1245-2019 · Class III · reported 2019-05-01 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-01
- Where it went
- Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
- How much
- 10,284 bottles
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laborato
D-1246-2019 · Class III · reported 2019-05-01 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-543-01
- Where it went
- Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
- How much
- 3,444 bottles
Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc
D-1247-2019 · Class III · reported 2019-05-01 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01
- Where it went
- Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
- How much
- 324 bottles
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laborator
D-1243-2019 · Class III · reported 2019-05-01 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01
- Where it went
- Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
- How much
- 17,328 bottles
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laborator
D-1244-2019 · Class III · reported 2019-05-01 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-541-01
- Where it went
- Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
- How much
- 15,320 bottles
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratori
D-1214-2018 · Class III · reported 2018-09-26 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
- Product
- Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01
- Where it went
- U.S.A. Nationwide
- How much
- 4716 bottle
Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an o
D-1126-2017 · Class II · reported 2017-09-06 · Terminated
- Why it was recalled
- Defective container: Oral solution leaking from container.
- Product
- Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01
- Where it went
- U.S.A. Nationwide
- How much
- 34,824 bottles
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LA
D-308-2013 · Class II · reported 2013-05-08 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
- Product
- Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
- Where it went
- Nationwide and Puerto Rico
- How much
- 26,100 vials
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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