CLASS II ONGOING Drug recall · Reported 10 Jun 2026 · FDA Enforcement Report
CAREone, Extra Strength Calcium Antacid, Calcium Carbonate 750 mg recalled
Guardian Drug is recalling CAREone, Extra Strength Calcium Antacid, Calcium Carbonate 750 mg, distributed nationwide in the US. The recall was initiated on 28 May 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0565-2026
- FDA event ID
- 99098
- Recalling firm
- Guardian Drug, Dayton, NJ
- Manufacturer
- Retail Business Services, LLC.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2026
- FDA classified
- 3 Jun 2026
- Reported
- 10 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 28 May 2026 | Recall initiated by company | |
| 3 Jun 2026 | Classified by FDA | +6 days |
| 10 Jun 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign substance: small metallic particles in chewable tablets.
Product as listed by the FDA
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80.
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Presence of foreign substance: small metallic particles in chewable tablets.
Which lots are affected?
Lot #: 1276118, 1276119, expires: JAN 2029.
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
22 other products · FDA event 99098This product is part of a recall event; the main page for the event is Haleon Calcium Carbonate Tums Antacid recalled by Guardian Drug Co.
More recalls from Guardian Drug
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Kirkland Signature, Ultra Strength Antacid recalled by Guardian Drug CoKirkland Ultra Stregth Antacid 171ab | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | Family Wellness, Ultra Strengt, Antacid Tablets recalled | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | Good Neighbor Pharmacy, extra strength Antacid Calcium recalledGood Neighbor Pharmacy Antacid | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | Harris Teeter, Ultra Strength Antacid, Calcium Carbonate 1000 mg recalled | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | H.E.B Extra Strength Calcium Carbonate Antacid Tablets recalledHeb Extra Stregth Antacid | Guardian Drug | Particulate Matter | Nationwide |
Other Calcium Carbonate recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Kirkland Signature, Ultra Strength Antacid recalled by Guardian Drug CoKirkland Ultra Stregth Antacid 171ab | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | Good Neighbor Pharmacy, extra strength Antacid Calcium recalledGood Neighbor Pharmacy Antacid | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | H.E.B Extra Strength Calcium Carbonate Antacid Tablets recalledHeb Extra Stregth Antacid | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | Family Wellness, Ultra Strengt, Antacid Tablets recalledFamily Wellness Ultra Strength Assorted Fruit Antacid | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | TopCare health, Extra Strength, Antacid Tablets recalledTopcare Extra Strength Antacid | Guardian Drug | Particulate Matter | Nationwide |