Martin Avenue Pharmacy Recalls Compounded Hydromorphone and Bupivacaine Injections
Martin Avenue Pharmacy is voluntarily recalling compounded hydromorphone and bupivacaine injections due to quality control issues that may compromise sterility.
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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk to sterility assurance in a sterile injection product.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This action includes Hydromorphone HCl/bupivacaine (PF) 10 mg/7.5 mg/mL injection packaged in 30 mL or 60 mL syringes. The recall is being initiated in connection with a recent FDA inspection.
The recall was triggered by observations associated with certain quality control procedures that present a risk to sterility assurance. The agency has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected product is distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact Martin Avenue Pharmacy or their healthcare provider for further instructions on disposal or replacement.
The recalled product
- Product
- Hydromorphone HCl/bupivacaine (PF) 10 mg/7.5 mg/mL injection packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
- Hazard
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 Number: 08182014@45
- Exp 9/17/2014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Martin Avenue Pharmacy, Inc. 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 118 products in this recall →Related recalls
Same manufacturer · Martin Avenue Pharmacy, Inc.
See all →- SevereMartin Avenue Pharmacy Recalls Atropine Sulfate Eye Drops for Sterility Concerns
FDA (Drugs) · 2014-11-05
- SevereMartin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
FDA (Drugs) · 2014-11-05
- HighMartin Avenue Pharmacy Recalls Tri-mix T50 Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-11-05
- HighMartin Avenue Pharmacy Recalls Tri-mix ST2 Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-11-05
- HighMartin Avenue Pharmacy Recalls PGE 4 Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-11-05
Same hazard · sterility risk
See all →- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereFDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighMedline Medical Procedure Kits Recalled for High Endotoxin Levels
FDA (Devices) · 2026-05-06
- HighCook Medical tracheostomy introducer sets labeled with overstated expiration dates
FDA (Devices) · 2026-04-15
Similar recalls
- SevereHydromorphone and Bupivacaine Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereFDA Recalls Hydromorphone and Bupivacaine Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereHartley Medical Center Pharmacy Recalls Hydromorphone and Bupivacaine Syringes
FDA (Drugs) · 2016-03-16
- SevereHydromorphone and Bupivacaine Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereHydromorphone and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereFDA Recalls Compounded Intrathecal Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23