Fallon Pharmacy Recalls Bevacizumab Syringes Due to Sterility Concerns
Fallon Wellness Pharmacy is recalling 241 prefilled Bevacizumab syringes because third-party testing suggests sterility test results may have been inaccurate.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant safety concern like sterility assurance in a drug product warrants a score of 4 (Severe), particularly given the potential for serious infection if the product is not sterile.
Plain-English summary
Fallon Wellness Pharmacy, located in Latham, New York, is recalling 241 prefilled syringes of Bevacizumab 25mg/mL. The affected product is available in 0.05 mL and 0.06 mL sizes. The specific lot number is 08052013@84, with an expiration date of 11/5/2013.
The recall was initiated due to a lack of assurance of sterility. Third-party laboratory testing indicated that previous test results reported as passing sterility may have been inaccurate. This raises concerns that the product may not be sterile.
The affected syringes were distributed in New York and Maine. Patients who received this medication should contact their healthcare provider or pharmacist for further instructions on what to do with the remaining product.
The recalled product
- Product
- Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110.
- Manufacturer
- Fallon Wellness Pharmacy Llc
- Category
- Drug — Biologic / Injectable
- Hazard
- Affected units
- 241
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 (2)
- Lot #: 08052013@84
- Exp 11/5/2013
Distribution
Related recalls
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereBella Pharmaceuticals Recalls Bevacizumab Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-09-20
- SevereAvella Recalls Bevacizumab Prefilled Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-06-05
- HighFallon Wellness Pharmacy Recalls Hydroxocobalamin Injections Due to Sterility Concerns
FDA (Drugs) · 2015-05-20
- SevereFallon Wellness Pharmacy Recalls Methylcobolamin Injections Due to Sterility Concerns
FDA (Drugs) · 2015-05-20
- SevereFallon Wellness Pharmacy Recalls Methylcobalamin/B-Complex Injection Due to Sterility Concerns
FDA (Drugs) · 2015-05-20
- SevereBella Pharmaceuticals Recalls BevaDex Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-09-20