Hi-Tech Pharmacal Recalls Subpotent Bucalsep Oral Solution
Hi-Tech Pharmacal Co., Inc. is recalling 10,440 bottles of Bucalsep Oral Solution because the cetylpyridinium chloride ingredient is subpotent.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard is a subpotent ingredient, which is a quality issue rather than a direct safety threat like contamination or injury.
Plain-English summary
Hi-Tech Pharmacal Co., Inc. is recalling 10,440 bottles of Bucalsep Oral Solution, 1 Fl. Oz. (30 mL). The product is manufactured for Gil Pharmaceutical Corp. in Ponce, Puerto Rico. The recall is limited to Lot 611614, which has an expiration date of 09/2013.
The recall was initiated because the cetylpyridinium chloride ingredient in the product is subpotent, meaning it does not contain the full amount of the active ingredient stated on the label. The product was distributed in Puerto Rico.
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
- BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01
- Manufacturer
- Hi-Tech Pharmacal Co., Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 10,440
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)
- Lot 611614 (exp. 09/2013)
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Hi-Tech Pharmacal Co., Inc.
See all →- LowHi-Tech Pharmacal Recalls Liquid Vitamin C Due to pH Issues
FDA (Food) · 2016-12-28
- LowHi-Tech Pharmacal Recalls Liquid Vitamin C Due to Low Active Ingredient
FDA (Food) · 2016-12-28
- ModerateHi-Tech Pharmacal Recalls Ferrous Sulfate Elixir Due to pH Issues
FDA (Food) · 2015-03-11
- SevereHi-Tech Pharmacal Recalls HydrOXYzine Hydrochloride Oral Solution Due to Impurity
FDA (Drugs) · 2014-11-05
- LowHi-Tech Pharmacal Recalls Acyclovir Oral Suspension for Stability Failures
FDA (Drugs) · 2014-01-01
Same hazard · subpotent ingredient
See all →- ModerateCollagen supplement recalled over manganese below the labeled quantity
FDA (Food) · 2026-02-11
- ModerateMedline Suture Removal Tray Recalled for Subpotent Iodine Concentration
FDA (Drugs) · 2018-02-07
- ModerateSandoz Recalls Subpotent Fosinopril Sodium and Hydrochlorothiazide Tablets
FDA (Drugs) · 2014-01-08
- ModerateStayma Recalls Duet DHA 430 Vitamins for Subpotent Beta Carotene
FDA (Drugs) · 2013-08-28
- LowDuet DHA 430 ec Recalled for Subpotent Beta Carotene
FDA (Drugs) · 2013-08-28
Similar recalls
- ModerateHi-Tech Pharmacal Recalls Subpotent HydrOXYzine Hydrochloride Oral Solution
FDA (Drugs) · 2013-06-26
- LowHi-Tech Pharmacal Recalls Subpotent Acetic Acid Otic Solution
FDA (Drugs) · 2013-05-08
- ModerateHi-Tech Pharmacal Recalls Subpotent Giltuss and Exactuss Cough Medicines
FDA (Drugs) · 2013-10-30
- LowMallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution for Low Potency
FDA (Drugs) · 2012-08-08
- ModerateAkorn Recalls Subpotent Sodium Chloride Ophthalmic Solution
FDA (Drugs) · 2016-11-09
- SevereAkorn Recalls Subpotent Hydrocortisone and Acetic Acid Otic Solution
FDA (Drugs) · 2020-02-19