Safecor Health Recalls Haloperidol Oral Solution Due to Leaking Bottles
Safecor Health is recalling 3,532 bottles of Haloperidol Oral Solution because customer complaints confirmed the bottles were leaking.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a packaging defect (leaking) rather than a chemical contamination or dosage error, and no injuries or illnesses are reported in the source text.
Plain-English summary
Safecor Health, LLC is recalling 3,532 amber bottles of Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL. The product is a prescription-only medication manufactured by Silarx Pharmaceuticals Inc. and packaged by Safecor Health. The specific lot number is 846881, with an expiration date of 01/16.
The recall was initiated due to confirmed customer complaints regarding defective containers. Specifically, the bottles were found to be leaking. The agency has classified this recall as Class II.
The affected product was distributed in New Jersey. Consumers and healthcare providers who have this specific lot of Haloperidol Oral Solution should stop using it and contact their pharmacist or healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.
- Manufacturer
- Safecor Health, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 3,532
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 (2)
- Lot #846881
- Exp 01/16
Distribution
Distributed in 1 state:
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