Hydrocortisone Suspension Recalled for Sterility and Stability Concerns
Health Innovations Pharmacy is recalling Hydrocortisone 1.6 mg/0.5 mL Suspension due to quality control issues affecting sterility and stability.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk to sterility and quality assurance for a drug product, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Hydrocortisone 1.6 mg/0.5 mL Suspension. The recall is being conducted due to recent inspection observations associated with certain quality control procedures. These observations present a risk to the sterility and quality assurance of the product, as stability data does not support the expiry date.
The recall covers all lots of the product. The distribution pattern is listed as NC, indicating the product was distributed in North Carolina. No specific illness or injury reports are mentioned in the source text.
Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Hydrocortisone 1.6 mg/0.5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Sterile Suspension
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 risk
See all →- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereFDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighMedline Medical Procedure Kits Recalled for High Endotoxin Levels
FDA (Devices) · 2026-05-06
- HighCook Medical tracheostomy introducer sets labeled with overstated expiration dates
FDA (Devices) · 2026-04-15
Similar recalls
- SevereMethotrexate Intraocular Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-03-12
- SevereNora Apothecary Recalls Hydroxyprogesterone Injections Due to Sterility Concerns
FDA (Drugs) · 2013-06-05
- ModerateAkorn Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Low Potency
FDA (Drugs) · 2019-03-27
- HighHydrocortisone Sterile Injection Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- LowHi-Tech Pharmacal Recalls Acyclovir Oral Suspension for Stability Failures
FDA (Drugs) · 2014-01-01
- SevereClinical Specialties Compounding Pharmacy Recalls Hydroxyprogesterone Due to Sterility Concerns
FDA (Drugs) · 2013-07-10