FDA DrugsClass II
TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHE...
Published: June 10, 2026Recall ID: D-0578-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of foreign substance: small metallic particles in chewable tablets.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Dayton |
| State | NJ |
| Openfda › Upc | 0036800498358 |
| Openfda › Unii | H0G9379FGK |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 308915 |
| Openfda › Spl id | a7a99479-5f95-4c10-94f6-6505370f12a7 |
| Openfda › Brand name | TOPCARE EXTRA STRENGTH ANTACID |
| Openfda › Spl set id | 0aefbd70-4103-410c-83b2-f7baa0b80ddd |
| Openfda › Package ndc | 76162-128-22 |
| Openfda › Product ndc | 76162-128 |
| Openfda › Generic name | CALCIUM CARBONATE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | CALCIUM CARBONATE |
| Openfda › Manufacturer name | Topco Associates, LLC |
| Openfda › Application number | M001 |
| Openfda › Is original packager | true |
| Event id | 99098 |
| Address 1 | 2 Charles Ct |
| Code info | Lot #: 1276119, expires: JAN- 2029. |
| Postal code | 08810-1508 |
| Report date | 20260610 |
| Product type | Drugs |
| Reason for recall | Presence of foreign substance: small metallic particles in chewable tablets. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260528 |
| Initial firm notification | Letter |
| Center classification date | 20260603 |
Overview
- Recalling FirmGuardian Drug Co. Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionU.S.A. Nationwide