Drug recall: CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe &…
Class II FDA enforcement event 99278. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Bell Pharmaceuticals, Inc started this drug recall on 25 Jun 2026. The firm address in the FDA record is in Belle Plaine, MN. FDA put the recall in Class II. FDA event 99278 has 11 product records. The first FDA enforcement report date is 22 Jul 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
U.S Nationwide
Recalling firm
Bell Pharmaceuticals, Inc, Belle Plaine, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0678-2026 | CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895, | 106,301 units | Class II | Ongoing | 22 Jul 2026 |
| D-0679-2026 | Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01. | 29, 474 units | Class II | Ongoing | 22 Jul 2026 |
| D-0680-2026 | QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376. | 15, 843 units | Class II | Ongoing | 22 Jul 2026 |
| D-0681-2026 | TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. | 16,156 units | Class II | Ongoing | 22 Jul 2026 |
| D-0682-2026 | AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005. | 5,762 units | Class II | Ongoing | 22 Jul 2026 |
| D-0683-2026 | FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320. | 11, 977 units | Class II | Ongoing | 22 Jul 2026 |
| D-0684-2026 | GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428. | 20, 160 units | Class II | Ongoing | 22 Jul 2026 |
| D-0685-2026 | LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017. | 5, 471 units | Class II | Ongoing | 22 Jul 2026 |
| D-0686-2026 | Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141. | 31,094 units | Class II | Ongoing | 22 Jul 2026 |
| D-0687-2026 | meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. | 993 units | Class II | Ongoing | 22 Jul 2026 |
| D-0688-2026 | CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785. | 1,201 units | Class II | Ongoing | 22 Jul 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2026
- 234
- Share of these events in Class II
- 74%
- Product records in this event
- 11
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-0678-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 99278. https://recallregister.com/fda/ii/99278/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
U.S Nationwide
- What quantity of product is in FDA event 99278?
- The event has 11 product records. The first record gives this quantity:
106,301 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2026 have the same class?
- 74% of the 234 drug events that started in 2026 are in Class II.