Breckenridge Recalls Zoledronic Acid Injection Due to Impurity Failures
Breckenridge Pharmaceutical is recalling 900 vials of Zoledronic Acid Injection because stability testing revealed out-of-specification impurities.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling 900 vials of Zoledronic Acid Injection 5 mg/100 mL. The product is a sterile solution for intravenous infusion, distributed nationwide in the U.S. The specific lots affected are # 5553.044E and # 5553.044F, with an expiration date of 04/30/2021.
The recall was initiated because the product failed impurities and degradation specifications. Out-of-specification results were obtained for impurities during stability testing. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare providers and patients should stop using the affected lots and contact Breckenridge Pharmaceutical for further instructions or returns.
The recalled product
- Product
- Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hun
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 5553.044E
- 5553.044F
- Exp. 04/30/2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Breckenridge Pharmaceutical, Inc
See all →- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- HighDuloxetine delayed-release capsules recalled over a nitrosamine impurity above FDA limits
FDA (Drugs) · 2025-12-10
- HighIntelliVue MX550 patient monitors recalled over an alarm activation issue
FDA (Drugs) · 2025-12-10
Same hazard · impurities
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMethohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide
FDA (Drugs) · 2026-07-15
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08