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Opioid painkillers

FDA recalls

19 rows

DateCompany and reasonClass
Aug 3, 2026Fresenius Kabi USA, LLC
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.		Class I · Ongoing
Jan 13, 2026Amerisource Health Services LLC
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.		Class II · Ongoing
Nov 25, 2025Winder Laboratories, LLC
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.		Class III · Ongoing
Feb 5, 2025Sun Pharmaceutical Industries Inc
Failed Dissolution Specifications		Class II · Ongoing
Jan 30, 2025Alvogen, Inc
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.		Class I · Ongoing
Apr 25, 2024Rubicon Research Private Limited
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol		Class II · Ongoing
Mar 11, 2024Hikma Pharmaceuticals USA Inc.
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.		Class II · Ongoing
Oct 19, 2023Zyla Life Sciences US Inc.
Sub-potent Drug: Lower potency than labeled.		Class III · Ongoing
Dec 28, 2021Lupin Pharmaceuticals Inc.
Out-of-specification impurity test result observed at 18-month long term stability time point.		Class III · Terminated
Sep 16, 2021Fresenius Kabi USA LLC
Defective container: Cracked vials leading to lack of sterility assurance		Class II · Terminated
Aug 18, 2021Rhodes Pharmaceuticals, L.P.
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle		Class II · Terminated
Apr 26, 2021Kvk-Tech, Inc.
Failed Impurities/Degradation Specifications		Class III · Terminated
Apr 18, 2019Alvogen, Inc
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.		Class I · Terminated
Apr 9, 2019Lupin Somerset
Failed Impurities/Degradation Specifications		Class III · Terminated
Aug 22, 2018Lupin Somerset
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.		Class III · Terminated
Mar 4, 2018Novel Laboratories, Inc.
Failed Impurities/Degradation Specifications		Class III · Terminated
Jan 21, 2018Ascent Pharmaceuticals, Inc.
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol		Class III · Terminated
Jun 14, 2017Tris Pharma Inc.
Defective container: Oral solution leaking from container.		Class II · Terminated
Aug 27, 2012Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial		Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).