Health Innovations Pharmacy Recalls Glycopyrrolate Suspension Due to Sterility Concerns
Health Innovations Pharmacy is recalling Glycopyrrolate 0.2 mg/1 mL Suspension (Robinul) because inspection findings indicate a lack of assurance regarding sterility and stability data.
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 are assigned a severity score of 4 (Severe), particularly when involving significant quality assurance risks like sterility failures in injectable medications.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling all lots of Glycopyrrolate 0.2 mg/1 mL Suspension (Robinul). The product was distributed in North Carolina.
The recall was initiated due to recent inspection observations associated with certain quality control procedures. These observations present a risk to sterility and quality assurance, specifically regarding the lack of assurance of sterility and stability data supporting the product's expiry.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Glycopyrrolate 0.2 mg/1 mL Susp (Robinul), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Injectable
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 65 recalled by Health Innovations 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 65 products in this recall →Related recalls
Same manufacturer · Health Innovations Pharmacy, Inc
See all →- ModerateCarvedilol 1.25 mg/mL Recalled for Sterility and Stability Concerns
FDA (Drugs) · 2015-05-20
- HighProgest Cream Recalled for Sterility and Stability Concerns
FDA (Drugs) · 2015-05-20
- HighHealth Innovations Pharmacy Recalls Phospholine Iodide Eye Drops
FDA (Drugs) · 2015-05-20
- HighNortriptyline Suspension Recalled for Sterility and Stability Concerns
FDA (Drugs) · 2015-05-20
- HighHealth Innovations Pharmacy Recalls Naltrexone Capsules Due to Sterility Concerns
FDA (Drugs) · 2015-05-20
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
- ModeratePharmakon Recalls Glycopyrrolate Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-02-03
- HighInjectable drug product recalled due to sterility assurance failure
FDA (Drugs) · 2023-02-01
- SevereGuardian Pharmacy Recalls Glycopyrrolate Syringes Due to Sterility Concerns
FDA (Drugs) · 2018-08-15
- HighGlycopyrrolate Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-06-08
- SevereSCA Pharmaceuticals Recalls Glycopyrrolate Syringes Due to Sterility Concerns
FDA (Drugs) · 2021-01-13
- HighAlbuterol Inhalation Solution Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-01