Flanax Antacid Recalled for Missing Tamper-Evident Cap Band
Belmora LLC is recalling 17,996 bottles of Flanax antacid because the caps lack a tamper-evident breakaway band.
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 indicates the product is not likely to cause adverse health consequences. The defect is limited to packaging (missing tamper-evident band) with no reported injuries or illnesses.
Plain-English summary
Belmora LLC is recalling 17,996 bottles of Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid. The product is distributed in 12 fl oz (355 mL) bottles with NDC 27854.101.01 and UPC 8 53030 00209 0. The recall affects lots 1321, 1322, 1323, and 1324.
The recall was initiated because the product lacks a tamper-evident breakaway band on the cap. This defect is classified as a packaging issue by the U.S. Food and Drug Administration.
The affected product was distributed nationwide. Consumers should check their bottles for the missing breakaway band and contact the distributor for further instructions if the defect is present.
The recalled product
- Product
- Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01.
- Manufacturer
- Belmora LLC
- Category
- Drug — Antacid
- Hazard
- Affected units
- 17,996
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 (4)
- Lot #: 1321
- 1322
- 1323
- and 1324
Distribution
Distributed nationwide across the United States.
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