Clonidine Hydrochloride Tablets Recalled Due to Temperature Abuse During Manufacturing
FDA recalls 63 bottles of Clonidine Hydrochloride Tablets (0.1 mg, NDC 00228-2127-10) distributed nationwide due to temperature abuse causing cGMP deviations 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall without reported illnesses, hospitalizations, or injuries. Temperature abuse during manufacturing is a quality-control risk to drug efficacy, warranting High severity per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Clonidine Hydrochloride Tablets, USP, 0.1 mg (100-count bottles, manufactured by Teva/Actavis, NDC 00228-2127-10) are being recalled due to current good manufacturing practice (cGMP) deviations caused by temperature abuse. The product was distributed nationwide, affecting 63 bottles.
McKesson Medical-Surgical Inc., the recalling firm, issued this recall. The firm is unable to identify specific lot numbers for each customer but has distributed letters with the dates products may have been shipped.
Patients should contact their healthcare provider or pharmacist with questions about this recall and their medication.
The recalled product
- Product
- Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG: Teva/Actavis, NDC 00228-2127-10
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
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 · temperature abuse
See all →- SevereKayem Foods Recalls Ready-to-Eat Meat and Poultry Due to Temperature Abuse
USDA FSIS · 2026-10-17
- ModerateZoladex Goserelin Implant Recalled Due to Temperature Abuse
FDA (Drugs) · 2026-10-07
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
Similar recalls
- ModerateMutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations
FDA (Drugs) · 2015-08-05
- ModerateCardinal Health Recalls Cetirizine Hydrochloride Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateCardinal Health Recalls Amantadine Hydrochloride Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModeratePD-Rx Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations
FDA (Drugs) · 2016-01-06
- HighTriamterene and Hydrochlorothiazide Capsules Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- ModerateCyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination
FDA (Drugs) · 2021-09-08