Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns
Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after an FDA inspection identified concerns regarding the lack of sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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 for significant injury or health risk potential.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products. The recall was initiated after an FDA inspection found concerns regarding the lack of sterility assurance for these products.
The affected products include papaverine phentolamine prostaglandin (22.5/0.83 mg/15 mcg/mL) in 5 mL units. The recall covers all lots distributed in California.
Consumers who have these products should contact their healthcare provider or the pharmacy for further instructions on how to proceed.
The recalled product
- Product
- papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
- Manufacturer
- Abbott's Compounding 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 (1)
- All lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 43 recalled by Abbott's Compounding 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 43 products in this recall →Related recalls
Same manufacturer · Abbott's Compounding Pharmacy, Inc.
See all →- HighAbbott's Compounding Pharmacy Recalls Methylcobalamine Due to Sterility Concerns
FDA (Drugs) · 2016-02-24
- SevereAbbott's Compounding Pharmacy Recalls Sterile Compounded Papaverine Phentolamine Products
FDA (Drugs) · 2016-02-24
- SevereAbbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns
FDA (Drugs) · 2016-02-24
- SevereAbbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns
FDA (Drugs) · 2016-02-24
- SevereAbbott's Compounding Pharmacy Recalls Sterile Hydroxyprogesterone Due to Sterility Concerns
FDA (Drugs) · 2016-02-24
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15