CAREone, 1000 mg recall — Guardian Drug Co. Inc. (Class II)
Guardian Drug Co. Inc. is recorded by the U.S. Food and Drug Administration (FDA) as recalling CAREone, 1000 mg — a Class II recall, initiated 2026-05-28 and posted to the FDA enforcement report on 2026-06-10, under recall number D-0566-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Presence of foreign substance: small metallic particles in chewable tablets.”. From the product description, the form is chewable tablets and the strength given is 1000 mg. 1 National Drug Code number is printed in the record: 72476-178-23. Distribution is recorded as “U.S.A. Nationwide” — Nationwide (US), with the recalling firm on record in NJ, United States. The FDA files it under event ID 99098 together with 22 other recall numbers, all listed and linked below. Within that event this is the strength 1000 mg, form Chewable Tablets and ndc 72476-178-23 configuration; the sibling records differ on strength, package, form and ndc, and 1 more and match on everything else the source states. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.
Regulatory snapshot
| Recall number | D-0566-2026 |
|---|---|
| FDA event ID | 99098 (23 recall numbers) |
| Classification | Class II (intermediate regulatory tier) |
| Status | Ongoing |
| Recalling firm | Guardian Drug Co. Inc. |
| Recall initiated | 2026-05-28 |
| Reported by FDA | 2026-06-10 |
| Report lag | 13 days from initiation to report |
| Distribution | U.S.A. Nationwide — Nationwide (US) |
| Firm location on record | NJ, United States |
| Product description (source) | CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23. |
Reason reported by FDA
Presence of foreign substance: small metallic particles in chewable tablets.
10 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.
Product identifiers in this record
4 identifying values matched by exact pattern in the 22-word product description above; each is a literal substring of it.
| Product named | CAREone |
|---|---|
| Form | Chewable Tablets |
| Strength | 1000 mg |
| NDC | 72476-178-23 |
| Distributed by | FOODHOLD U.S.A, LLC |
Which configuration this record is
23 recall numbers share event 99098. They differ on strength, package, form, ndc and product named and agree on everything else the source states, so those are the values to check a package against.
Shared across all 23 records under this event: fda tier Class II; recalling firm Guardian Drug Co. Inc.; the same reason text; initiated 2026-05-28; reported 2026-06-10.
Event context: 23 recall numbers under event 99098
One enforcement action, 23 recall numbers: the FDA filed 22 further configurations of this action under event 99098. Each keeps its own recall number and dates.
| Recall record | Recall number | FDA tier | Strength / form | NDC | Reported |
|---|---|---|---|---|---|
| KIRKLAND Signature, 1000 mg | D-0557-2026 | Class II | 1000 mg | 63981-171-80 | 2026-06-10 |
| HALEON CALCIUM CARBONATE TUMS ANTACID, 1000 mg | D-0558-2026 | Class II | 1000 mg · Tablets | — | 2026-06-10 |
| HALEON CALCIUM CARBONATE TUMS ANTACID, 750 mg | D-0559-2026 | Class II | 750 mg · Tablets | — | 2026-06-10 |
| Good Neighbor Pharmacy, 750 mg | D-0560-2026 | Class II | 750 mg | 24385-106-80 | 2026-06-10 |
| Good Neighbor Pharmacy, 1000 mg | D-0561-2026 | Class II | 1000 mg · Chewable Tablets | 24385-595-23 | 2026-06-10 |
| Extra strength Antacid Calcium Carbonate 750 mg | D-0562-2026 | Class II | 750 mg · Chewable Tablets | — | 2026-06-10 |
| 24/7 life BY 7-ELEVEN | D-0563-2026 | Class II | 7 l · Chewable Tablets | — | 2026-06-10 |
| MARKET BASKET ANTACID Calcium Carbonate 1000 mg | D-0564-2026 | Class II | 1000 mg · Tablets | — | 2026-06-10 |
| CAREone, 750 mg | D-0565-2026 | Class II | 750 mg · Chewable Tablets | 72476-127-80 | 2026-06-10 |
| DISCOUNT drug mart, 750 mg | D-0567-2026 | Class II | 750 mg · Tablets | — | 2026-06-10 |
| FAMILY WELLNESS, 1000 mg | D-0568-2026 | Class II | 1000 mg · Chewable Tablets | 55319-171-68 | 2026-06-10 |
| FAMILY WELLNESS, 1000 mg | D-0569-2026 | Class II | 1000 mg · Chewable Tablets | — | 2026-06-10 |
| Harris Teeter, 1000 mg | D-0570-2026 | Class II | 1000 mg · Chewable Tablets | — | 2026-06-10 |
| HyVee, 750 mg | D-0571-2026 | Class II | 750 mg · Chewable Tablets | — | 2026-06-10 |
| HyVee, 1000 mg | D-0572-2026 | Class II | 1000 mg · Chewable Tablets | — | 2026-06-10 |
| H.E.B Extra Strength Calcium Carbonate Antacid Tablets, 750 mg | D-0573-2026 | Class II | 750 mg · Chewable Tablets | 37808-136-22 | 2026-06-10 |
| GOODSENSE Extra Strength, 750 mg | D-0574-2026 | Class II | 750 mg · Chewable Tablets | 50804-129-22 | 2026-06-10 |
| GOODSENSE Ultra Strength, 1000 mg | D-0575-2026 | Class II | 1000 mg · Chewable Tablets | 50804-171-68 | 2026-06-10 |
| EQUALINE extra strength, 750mg | D-0576-2026 | Class II | 750mg · Chewable Tablets | 41163-129-22 | 2026-06-10 |
| EQUALINE ultra strength, 1000mg | D-0577-2026 | Class II | 1000mg · Chewable Tablets | 41163-171-68 | 2026-06-10 |
| TopCare health, 750mg | D-0578-2026 | Class II | 750mg · Chewable Tablets | 76162-128-22 | 2026-06-10 |
| TopCare health, 1000mg | D-0579-2026 | Class II | 1000mg · Chewable Tablets | 76162-129-68 | 2026-06-10 |
Other indexed recalls under the CareOne label
3 indexed records are labelled CareOne, a Foodhold U.S.A. label, over carbamide peroxide. Matching is on the product-name prefix of the FDA's own text, so other strengths and packages are included.
| Recall record | Recall number | Recalling firm | Strength / form | Reported |
|---|---|---|---|---|
| CAREone, 6.5% | D-0688-2026 | Bell Pharmaceuticals, Inc | 6.5% | 2026-07-22 |
Reading this record
Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 99098 returns all 23 of these recall numbers; a search on D-0566-2026 returns only this configuration. Match a package against 72476-178-23 at the FDA source to confirm it is covered.
Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Guardian Drug Co. Inc. (23 indexed records) aggregates this firm across datasets.
Coverage and limits of this record
This page reflects the openFDA enforcement report for D-0566-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.
Source & provenance
- Official source
- https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0566-2026%22
- Source dataset
- openFDA Drug Enforcement API
- Publication date
- 2026-06-10
- Ingested
- 2026-08-22
- Record hash
d248c8402008f4a3
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.