The Apothecary Recalls Sterile Injection Medications Due to Sterility Assurance Concerns
The Apothecary is recalling unexpired lots of sterile injection medications due to unsubstantiated validation of beyond-use dating, which raises concerns about 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe (4). While the source does not explicitly state hospitalizations, the lack of sterility assurance in injectable medications presents a significant risk of serious adverse health consequences, aligning with the Severe criteria for Class II recalls where the hazard is not merely theoretical or minor.
Plain-English summary
The Apothecary, a compounding pharmacy in Sartell, Minnesota, is recalling unexpired lots of medications containing Calcium Gluconate, Papaverine, Phentolamine, and/or Prostaglandin. The recall is being conducted due to a lack of assurance of sterility resulting from unsubstantiated validation of beyond-use dating.
The affected products are prescription-only sterile injection medications distributed in Minnesota. The recall includes specific lots identified by the codes 06201604@15, 19201602@3, and 06201604@8. The source text does not specify the exact number of units affected or the specific dates of distribution.
Patients who have received these medications should contact their healthcare provider for guidance. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
- Manufacturer
- W & C dba The Apothecary
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 #: 06201604@15
- 19201602@3
- 06201604@8
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by W & C dba The Apothecary 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 5 products in this recall →Related recalls
Same manufacturer · W & C dba The Apothecary
See all →- SevereThe Apothecary Recalls Calcium Gluconate IV Bags Due to Sterility Concerns
FDA (Drugs) · 2016-09-28
- SevereCalcium Gluconate Syringes Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-09-28
- SevereThe Apothecary Recalls Sterile Medications Due to Sterility Assurance Issues
FDA (Drugs) · 2016-09-28
- SevereThe Apothecary Recalls Prostaglandin and Other Medications Due to Sterility Concerns
FDA (Drugs) · 2016-09-28
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
- HighInjectable Drug Recalled Over Failure to Assure Product Sterility
FDA (Drugs) · 2022-11-09
- HighCompounded Injectable Drug Recalled Due to Sterility Assurance Defect
FDA (Drugs) · 2022-11-09
- SevereFDA Recalls Papaverine, Phentolamine, and Alprostadil Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-11-12
- HighCompounded Injectable Medication Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-11-09
- SevereFDA Recalls Injectable Solution Due to Lack of Sterility Assurance
FDA (Drugs) · 2015-11-04
- HighPharmacy Compounded Injection Recalled for Sterility Assurance Failure
FDA (Drugs) · 2022-11-09