AUDIOLOGIST'S CHOICE, 6.5% recall — Bell Pharmaceuticals, Inc (Class II)
Bell Pharmaceuticals, Inc is recorded by the U.S. Food and Drug Administration (FDA) as recalling AUDIOLOGIST'S CHOICE, 6.5% — a Class II recall, initiated 2026-06-25 and posted to the FDA enforcement report on 2026-07-22, under recall number D-0682-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).”. From the product description, the form is kit, the strengths given are 6.5% and 15 mL and the package is described as 0.5 Fl Oz (15 mL) and 1 bottle. 2 National Drug Code numbers are printed in the record: 59256-001-02 and 59256-836-34. Distribution is recorded as “U.S Nationwide” — Nationwide (US), with the recalling firm on record in MN, United States. The FDA files it under event ID 99278 together with 10 other recall numbers, all listed and linked below. Within that event this is the strength 6.5% · 15 mL, package 0.5 Fl Oz (15 mL) · 1 bottle and form Kit 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-0682-2026 |
|---|---|
| FDA event ID | 99278 (11 recall numbers) |
| Classification | Class II (intermediate regulatory tier) |
| Status | Ongoing |
| Recalling firm | Bell Pharmaceuticals, Inc |
| Recall initiated | 2026-06-25 |
| Reported by FDA | 2026-07-22 |
| Report lag | 27 days from initiation to report |
| Distribution | U.S Nationwide — Nationwide (US) |
| Firm location on record | MN, United States |
| Product description (source) | 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. |
Reason reported by FDA
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
13 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
8 identifying values matched by exact pattern in the 32-word product description above; each is a literal substring of it.
| Product named | AUDIOLOGIST'S CHOICE |
|---|---|
| Form | Kit |
| Strength | 6.5% · 15 mL |
| Package | 0.5 Fl Oz (15 mL) · 1 bottle |
| NDC | 59256-001-02 · 59256-836-34 |
| Distributed by | Oaktree Products Inc., St. Louis. MO 63005. |
Which configuration this record is
11 recall numbers share event 99278. 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.
| Attribute | This record (D-0682-2026) | D-0678-2026 | D-0679-2026 | D-0680-2026 | D-0681-2026 | D-0683-2026 | D-0684-2026 | D-0685-2026 | D-0686-2026 | D-0687-2026 | D-0688-2026 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Strength | 6.5% · 15 mL | 6.5% · 15 mL | 0.50 mL · 6.5% · 15 mL | 6.5% · 15 mL | 6.5% · 15 mL | 6.5% · 15 mL | 6.5% · 15 mL | 6.5% · 15 mL | 6.5% · 15 mL | 6.5% · 15 mL | 6.5% · 15 mL |
| Package | 0.5 Fl Oz (15 mL) · 1 bottle | 0.5 FL Oz (15 mL) | 2 bottles · 1 bottle | 1 bottle | 0.5 FL OZ (15 mL) · 1 bottle | 0.5 Fl Oz (15 mL) | 0.5 Fl Oz (15 mL) · 1 bottle | 0.5 Fl Oz (15 mL) · 0.5 FL OZ · 1 bottle | 0.5 FL OZ (15 mL) | 0.5 FL OZ (15 mL) | 0.5 FL OZ (15 mL) |
| Form | Kit | Drops | — | — | Drops | Kit | Kit | Drops | — | — | — |
| NDC | 59256-001-02 · 59256-836-34 | 51316-822-00 · 51316-823-00 | 68229-102-01 | 63868-026-15 · 63868-027-16 | 36800-835-33 · 36800-835-34 | 55319-835-01 | 46122-556-05 · 46122-557-05 | 70000-0689-1 · 70000-0688-1 | 70677-1154-01 | 41250-835-33 | 72476-838-34 |
| Product named | AUDIOLOGIST'S CHOICE | CVS Health | Clinere | QC Quality Choice | TopCare Health | FAMILY Wellness | GOOD NEIGHBOR PHARMACY | LEADER | Foster & Thrive | meijer | CAREone |
Shared across all 11 records under this event: fda tier Class II; recalling firm Bell Pharmaceuticals, Inc; the same reason text; initiated 2026-06-25; reported 2026-07-22.
Event context: 11 recall numbers under event 99278
One enforcement action, 11 recall numbers: the FDA filed 10 further configurations of this action under event 99278. Each keeps its own recall number and dates.
| Recall record | Recall number | FDA tier | Strength / form | NDC | Reported |
|---|---|---|---|---|---|
| CVS Health, 6.5% | D-0678-2026 | Class II | 6.5% · Drops | 51316-822-00 | 2026-07-22 |
| Clinere, 0.50 mL | D-0679-2026 | Class II | 0.50 mL | 68229-102-01 | 2026-07-22 |
| QC Quality Choice, 6.5% | D-0680-2026 | Class II | 6.5% | 63868-026-15 | 2026-07-22 |
| TopCare Health, 6.5% | D-0681-2026 | Class II | 6.5% · Drops | 36800-835-33 | 2026-07-22 |
| FAMILY Wellness, 6.5% | D-0683-2026 | Class II | 6.5% · Kit | 55319-835-01 | 2026-07-22 |
| GOOD NEIGHBOR PHARMACY, 6.5% | D-0684-2026 | Class II | 6.5% · Kit | 46122-556-05 | 2026-07-22 |
| LEADER, 6.5% | D-0685-2026 | Class II | 6.5% · Drops | 70000-0689-1 | 2026-07-22 |
| Foster & Thrive, 6.5% | D-0686-2026 | Class II | 6.5% | 70677-1154-01 | 2026-07-22 |
| meijer, 6.5% | D-0687-2026 | Class II | 6.5% | 41250-835-33 | 2026-07-22 |
| CAREone, 6.5% | D-0688-2026 | Class II | 6.5% | 72476-838-34 | 2026-07-22 |
Reported in the same month (2026-07)
111 enforcement reports carry a report date in 2026-07; these 8 are the Class II ones nearest this record.
| Recall record | Recall number | Recalling firm | FDA tier | Reported |
|---|---|---|---|---|
| Nystatin Cream USP, 15 g | D-0677-2026 | Padagis US LLC | Class II | 2026-07-22 |
| CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL) | D-0689-2026 | Chiesi Usa, Inc. | Class II | 2026-07-22 |
| BD ChloraPrep Clear, 2% | D-0690-2026 | Carefusion 213, LLC | Class II | 2026-07-22 |
| Methohexital Sodium for Injection, 500 mg | D-0662-2026 | Onesource Specialty Pharma Ltd | Class II | 2026-07-15 |
| Medline Remedy Specialized Silicone Cream (Hydraguard-D ), 59 mL | D-0663-2026 | Biomed Laboratories, Llc. | Class II | 2026-07-15 |
| Methohexital Sodium, 100 mg/10 mL | D-0664-2026 | Quva Pharma, Inc. | Class II | 2026-07-15 |
| Gasco Isopropyl Alcohol 70% | D-0665-2026 | Gasco Industrial Corp. | Class II | 2026-07-15 |
| Gasco Isopropyl Alcohol 70% | D-0666-2026 | Gasco Industrial Corp. | Class II | 2026-07-15 |
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 99278 returns all 11 of these recall numbers; a search on D-0682-2026 returns only this configuration. Match a package against 59256-001-02 and 59256-836-34 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); Bell Pharmaceuticals, Inc (11 indexed records) aggregates this firm across datasets.
Coverage and limits of this record
This page reflects the openFDA enforcement report for D-0682-2026 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-0682-2026%22
- Source dataset
- openFDA Drug Enforcement API
- Publication date
- 2026-07-22
- Ingested
- 2026-08-22
- Record hash
d12b8489291cca6d
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.