Sun Pharmaceutical Recalls Loperamide Hydrochloride Tablets Due to Labeling Error
Sun Pharmaceutical Industries is recalling 5,040 cartons of Loperamide Hydrochloride 2 mg tablets because the carton front and side panels display conflicting caplet counts.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the quantity of caplets, which fits the criteria for a Low severity score.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 5,040 cartons of Loperamide Hydrochloride 2 mg tablets. The product is an over-the-counter anti-diarrheal medication distributed in Ohio by Drug Mart-Food Fair Medina. The recall is limited to Lot 2979325 with an expiration date of 5/5021.
The recall was initiated due to a labeling discrepancy. The front panel of the carton indicates that it contains 24 caplets, while the side panel indicates 12 caplets. The actual drug product carton contains 24 caplets. This is classified as a labeling error not elsewhere classified.
Consumers who have purchased this specific lot of Loperamide Hydrochloride tablets should stop using the product and contact their pharmacist or the recalling firm for further instructions. The product is identified by NDC 53943-123-24 and UPC 0 93351 11270 6.
The recalled product
- Product
- LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE)
- Brand
- LOPERAMIDE HYDROCHLORIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — OTC Anti-Diarrheal
- Hazard
- Affected units
- 5,040
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: 2979325
- EXP 5/5021
UPCs (1)
- 093351112706
Distribution
Distributed in 1 state:
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