Topcare Extra Strength Antacid Tablet, Chewable
FDA Recall NDC 76162-128
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Topcare Extra Strength Antacid (NDC 76162-128). A significant event, classified as Class II, was initiated on May 28, 2026 by Topco Associates, Llc. The reported reason for this action was: "Presence of foreign substance: small metallic particles in chewable tablets."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of foreign substance: small metallic particles in chewable tablets.
May 28, 2026
Jun 10, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99098
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Guardian Drug Co. Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Product Description
TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-22.
Batch or Lot Expiration Information
Lot# : 1276119, expires: JAN- 2029.
Affected Packages Involved in this Recall
76162-128-22Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
