CLASS II ONGOING Drug recall · Reported 25 Oct 2023 · FDA Enforcement Report
Certain Over-The-Counter recalled by Dollar Tree Distribution
Dollar Tree Distribution is recalling Certain Over-The-Counter (, distributed nationwide in the US. The recall was initiated on 5 Oct 2023 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-0045-2024
- FDA event ID
- 93187
- Recalling firm
- Dollar Tree Distribution, Chesapeake, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Oct 2023
- FDA classified
- 16 Oct 2023
- Reported
- 25 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 5 Oct 2023 | Recall initiated by company | |
| 16 Oct 2023 | Classified by FDA | +11 days |
| 25 Oct 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Product as listed by the FDA
Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
Where it was distributed
Nationwide in the USA
Stores named: Dollar Tree
Questions about this recall
Is Certain Over-The-Counter ( recalled?
Yes. Dollar Tree Distribution recalled Certain Over-The-Counter ( on 5 Oct 2023. The recall is Class II and its status is Ongoing. Recall number D-0045-2024.
Why was it recalled?
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Which lots are affected?
Certain drug products sold by Family Dollar retail stores located in AL, AR, AZ, CA, CO, FL, GA, ID, KS, LA, MS, MT, ND, NE, NM, NV, OK, OR, SD, TX, UT, WA, and WY.
Where was it sold?
Nationwide in the USA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dollar Tree Distribution
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medical Device products purchased from Family Dollar retail recalled | Dollar Tree Distribution | Foreign Material | Nationwide |
| Drug | CLASS II | All Over-The-Counter recalled by Dollar Tree Distribution | Dollar Tree Distribution | Foreign Material | 6 states |
| Food | CLASS II | Food products purchased from Family Dollar retail stores recalled | Dollar Tree Distribution | Foreign Material | 6 states |
| Food | CLASS II | Dietary supplements purchased from Family Dollar retail recalled | Dollar Tree Distribution | Foreign Material | 6 states |
| Food | CLASS II | Candy Canes, Peppermint Flavor recalled by Dollar Tree Distribution | Dollar Tree Distribution | Foreign Material | Nationwide |