FDA Recalls Metoprolol Tablets Due to Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Metoprolol 50 mg tablets nationwide due to temperature abuse during manufacturing that may compromise medication stability. Patients should contact their pharmacist or physician.
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 for manufacturing quality deviation. No illnesses or injuries reported. Temperature abuse affecting pharmaceutical stability represents a potential risk-of-harm to medication efficacy and patient safety without documented patient harm, meeting the High severity criterion.
Plain-English summary
Metoprolol tablets 50 mg (100-count bottles, NDC 57664-0477-52) distributed by McKesson Medical-Surgical Inc. are being recalled nationwide. The recall is due to current good manufacturing practice (cGMP) deviations, specifically temperature abuse during manufacturing or storage that may affect the stability of the medication.
This recall affects Metoprolol prescriptions distributed to patients across the United States. Patients currently taking this medication should contact their pharmacy or prescribing physician immediately to determine whether their supply is affected and to discuss whether alternative medication is needed.
McKesson Medical-Surgical states it is unable to identify specific lot numbers for all affected consignees. Distribution letters containing the dates affected product may have been shipped have been sent to customers.
The recalled product
- Product
- Metoprolol tablets 50 mg, 100-count botte, Rx only, MFG: Sun Pharmaceuticals, NDC 57664-0477-52
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 1
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
- HighMetoprolol Succinate Extended-Release Tablets Recalled for Storage Temperature Deviations
FDA (Drugs) · 2024-01-03
- ModerateCardinal Health Recalls Methocarbamol Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- HighMetoprolol Succinate ER Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2023-02-22
- ModerateDr. Reddy's Recalls Metoprolol Succinate Tablets for Dissolution Failure
FDA (Drugs) · 2014-02-12
- ModerateMetoprolol Succinate ER Tablets Recall for Failed Dissolution
FDA (Drugs) · 2022-02-02
- Moderate