Abbott's Compounding Pharmacy Recalls Sterile Compounded Papaverine Phentolamine Products
Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded papaverine phentolamine products due to concerns about lack of sterility assurance found during an FDA inspection.
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, FDA Class II recalls with potential for serious injury or hospitalization (implied by lack of sterility assurance in sterile products) fall under the Severe category.
Plain-English summary
Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded papaverine phentolamine 30 mg/1mg/mL products. The affected products are available in 5 mL and 10 mL unit sizes and are distributed in California.
The recall was initiated after an FDA inspection identified concerns regarding the lack of sterility assurance for these sterile compounded products. The source text does not specify the number of units affected or report any illnesses or injuries.
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 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 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
- SevereAbbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns
FDA (Drugs) · 2016-02-24
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- SevereUS Compounding Recalls Bi-Mix Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-25
- SevereAnderson Compounding Pharmacy Recalls Papaverine and Phentolamine Vials
FDA (Drugs) · 2019-04-24
- SevereThe Apothecary Recalls Sterile Medications Due to Sterility Assurance Issues
FDA (Drugs) · 2016-09-28
- SevereFDA Recalls Compounded Papaverine-Phentolamine Injectable Due to Insanitary Conditions
FDA (Drugs) · 2019-04-17
- SevereFDA Recalls Papaverine/Phentolamine Injections Due to Sterility Concerns
FDA (Drugs) · 2014-01-15
- SevereFDA Recalls Papaverine, Phentolamine, and Alprostadil Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-11-12