Opioid and pain medication recalls
36 FDA-recorded recalls of opioid and pain medications, most recent Jun 2026 — newest first, straight from the FDA's own database.
The recalls here are concentrated in injectable and implanted products — loss of sterility assurance is the single largest reason in our data, alongside CGMP failures and one buprenorphine crystallisation finding. Strength labelling errors matter more in this class than almost anywhere else, because the difference between patch or tablet strengths is the difference between a dose and an overdose. Never stop an opioid abruptly on your own because of a recall: withdrawal is a medical event in itself, so confirm the lot against the FDA notice and contact the prescriber.
Buprenorphine HCl
Class IICrystallization; identified as Buprenorphine free base
Par Health USA, LLC · Jun 24, 2026
fentaNYL Citrate
Class IISubpotent Drug
IntegraDose Compounding Services LLC · May 27, 2026
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Class IIcGMP deviations.
Wells Pharma of Houston LLC · May 6, 2026
fentaNYL Citrate Injectable Solution
Class IIcGMP deviations.
Wells Pharma of Houston LLC · May 6, 2026
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Class IIcGMP deviations.
Wells Pharma of Houston LLC · May 6, 2026
fentaNYL Citrate Injectable Solution
Class IIcGMP deviations.
Wells Pharma of Houston LLC · May 6, 2026
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
Class IIcGMP deviations.
Wells Pharma of Houston LLC · May 6, 2026
traMADol Hydrochloride Tablets
Class IIFailed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Amneal Pharmaceuticals, LLC · Apr 8, 2026
Buprenorphine Hydrochloride
Class IICrystallization; identified as Buprenorphine free base
ENDO USA, Inc. · May 20, 2026
Oxycodone Hydrochloride Tablets
Class IIDefective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Amerisource Health Services LLC · Feb 18, 2026
Oxycodone and Acetaminophen CII Tablets USP
Class IIFailed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx, LLC · Jan 14, 2026
Oxycodone and Acetaminophen CII Tablets USP
Class IIFailed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx, LLC · Jan 14, 2026
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL)
Class IIICorrect Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Winder Laboratories, LLC · Dec 17, 2025
Hydromorphone HCL PF
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma, Inc. · Oct 22, 2025
FentaNYL Citrate PF
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma, Inc. · Oct 22, 2025
Fentanyl citrate
Class IICGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Park Avenue Compounding · Nov 26, 2025
FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL
Class IILack of Assurance of Sterility
Apollo Care, LLC · May 14, 2025
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL)
Class IIISuperpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
OurPharma LLC · Apr 30, 2025
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100…
Class IILack of Assurance of Sterility
QuVa Pharma, Inc. · Apr 2, 2025
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 m…
Class IILack of Assurance of Sterility
QuVa Pharma, Inc. · Apr 2, 2025
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 m…
Class IILack of Assurance of Sterility
QuVa Pharma, Inc. · Apr 2, 2025
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe
Class IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Safecor Health, LLC · Mar 12, 2025
Morphine Sulfate Extended-Release Tablets
Class IIFailed Dissolution Specifications
SUN PHARMACEUTICAL INDUSTRIES INC · Mar 12, 2025
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII
Class IILack of Assurance of Sterility
Fagron Compounding Services · Feb 26, 2025
Fentanyl Transdermal System CII
Class IDefective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Alvogen, Inc · Feb 26, 2025
Guaifenesin and Codeine Phosphate Oral Solution USP
Class IIISuperpotent; sodium benzoate preservative
PAI Holdings, LLC. dba Pharmaceutical Associates Inc · Feb 12, 2025
Methadone Hydrochloride Tablets
Class IIIFailed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
West-Ward Columbus Inc · Jan 15, 2025
Morphine Sulfate Extended-Release Tablets 15 mg
Class IIFailed Impurities/Degradation Specification
Dr. Reddy's Laboratories, Inc. · Nov 13, 2024
Morphine Sulfate Extended-Release Tablets 30 mg
Class IIFailed Impurities/Degradation Specification
Dr. Reddy's Laboratories, Inc. · Nov 13, 2024
Buprenorphine Hydrochloride Injection
Class IILack of Assurance of Sterility-The potential for incomplete crimp seals.
Pfizer Inc. · Jul 3, 2024
TraMADol HCl 50 mg Tablet
Class IIPresence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
RemedyRepack Inc. · May 15, 2024
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection
Class IIILabeling: Wrong Barcode
Hikma Injectables USA Inc · May 8, 2024
traMADol Hydrochloride Tablets
Class IIPresence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Rubicon Research Private Limited · May 15, 2024
fentaNYL Citrate 2
Class IILack of Assurance of Sterility: leaking bags
IntegraDose Compounding Services LLC · Apr 10, 2024
Infumorph (Preservative-free Morphine Sulfate Sterile Solution)
Class IIThe filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Hikma Pharmaceuticals USA Inc. · Mar 27, 2024
FentaNYL citrate
Class IILack of Assurance of Sterility: Firm did not perform process validation.
SSM Health Care St. Louis DBA SSM St. Clare Health Center · Apr 10, 2024
How to use this page
A drug appearing here does not mean your prescription is unsafe. Recalls name specific lots and manufacturers — open the recall to see the affected lot numbers, and match them against your bottle. Never stop a blood-pressure, cholesterol, diabetes, antidepressant or antibiotic medicine on your own because of a recall; confirm your lot, then ask your pharmacist for a replacement if it is affected.
Other categories: Blood pressure medication · Eye drop and ophthalmic · Cholesterol medication · Diabetes medication · Antidepressant · Antibiotic · Thyroid medication · Allergy and antihistamine · Hormonal and contraceptive · ADHD and stimulant medication · Seizure and epilepsy medication · Asthma and inhaler · Heartburn and acid-reflux medication. See also the full recalls tracker and the recall report.
Source: the openFDA drug Enforcement (recall) database. Recalls are matched to this category by the drug names in the FDA’s product description; a small number of category recalls may be missed if the description omits the ingredient. Figures are recall events, not units, and reflect our copy of the FDA data, refreshed daily. This is public regulatory data, not medical advice.