Innovative Compounding Pharmacy Recalls Hydroxyprogesterone Caproate Due to Sterility Concerns
Innovative Compounding Pharmacy is recalling Hydroxyprogesterone Caproate injections because the FDA cannot ensure the product is sterile. Patients in California, Maine, and Texas should stop using the medication.
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 FDA classifies this recall as Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are classified as Severe (Score 4), as they are not explicitly Class I but involve significant risk.
Plain-English summary
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy is recalling specific lots of Hydroxyprogesterone Caproate (BUD) 350mg/ml, 4 mL, Injectable. The recall was initiated because the U.S. Food and Drug Administration (FDA) has determined there is a lack of assurance of sterility for the affected product.
The recall covers two specific lots: Lot # 02212020@2, which expires after 04-21-2020, and Lot # 02262020@52, which expires after 04-26-2020. The product was distributed to patients in California, Maine, and Texas.
Patients who have received this medication should stop using it and contact their healthcare provider for further instructions. 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
- Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
- Category
- Drug — Injectable
- 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 (3)
- Lot #: 02212020@2
- Expires after 04-21-2020
- Lot #: 02262020@52 Expires after 04-26-2020
Distribution
Part of a larger recall action
This product is one of 5 recalled by Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy 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 · Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
See all →- SevereInnovative Compounding Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns
FDA (Drugs) · 2020-04-15
- SevereInnovative Compounding Pharmacy Recalls MIC-8 Injectable Due to Sterility Concerns
FDA (Drugs) · 2020-04-15
- SevereInnovative Compounding Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2020-04-15
- Severe
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
- SevereFDA Recalls Hydroxyprogesterone Caproate Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- HighFDA Recalls Hydroxyprogesterone Caproate Injectable Due to Compounding Conditions
FDA (Drugs) · 2019-04-17
- Severe
- SevereAxia Pharmaceutical Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
- SevereGreen Valley Drugs Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
- SevereFDA Recalls Hydroxyprogesterone Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-06-12