Naltrexone Hydrochloride tablets recalled due to manufacturing temperature control deviation
McKesson Medical-Surgical is recalling Naltrexone Hydrochloride 50 mg tablets distributed nationwide due to cGMP deviations related to temperature abuse during manufacturing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or adverse effects. This is a precautionary manufacturing quality control recall involving cGMP deviations and temperature abuse during production.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Naltrexone Hydrochloride Tablets, USP, 50 mg in 100-count bottles (NDC 0406-1170-03), manufactured by Mallinckrodt Inc. The recall was issued due to Current Good Manufacturing Practice (cGMP) deviations that occurred during manufacturing, specifically related to temperature control.
The recalled product was distributed nationwide throughout the United States. McKesson cannot identify which specific lot numbers were received by individual customers. However, notification letters sent to customers specify the date the product was distributed and the timeframe during which affected medication may have been shipped to them.
Customers and healthcare providers who received this product should refer to their notification letter from McKesson for specific instructions regarding product return or replacement.
The recalled product
- Product
- NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE)
- Brand
- NALTREXONE HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0304061170017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 130 products in this recall →Related recalls
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · cGMP deviation
See all →- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits
FDA (Drugs) · 2026-07-08
- SevereCinacalcet Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2026-07-08
- ModerateFentanyl Citrate Injectable Solution Recalled for cGMP Deviations
FDA (Drugs) · 2026-05-06
- ModerateIndomethacin Extended-Release Capsules recalled for cGMP deviations
FDA (Drugs) · 2025-06-11
- SevereLubricant Eye Drops Solution recalled due to sterility assurance concerns
FDA (Drugs) · 2025-05-14
Similar recalls
- HighFDA recalls Buspirone Hydrochloride tablets for manufacturing practice deviations
FDA (Drugs) · 2023-03-08
- ModerateCardinal Health Recalls Trazodone Hydrochloride Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateMcKesson Recalls Hydralazine Hydrochloride Injection Due to Temperature Abuse
FDA (Drugs) · 2017-04-19
- HighDrug Recall: Hydralazine Hydrochloride Tablets Due to Improper Storage
FDA (Drugs) · 2024-01-03
- ModerateAccord Healthcare Recalls Buspirone Hydrochloride Due to Manufacturing Deviations
FDA (Drugs) · 2023-03-08
- ModerateDicyclomine Hydrochloride Tablets Recalled for Improper Storage Conditions
FDA (Drugs) · 2024-01-03