Food, drugs, devices › Dollar Tree Distribution, Inc.
Drug recall: Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
FDA enforcement event 93187 is a drug recall by Dollar Tree Distribution, Inc. of Chesapeake, VA, initiated 5 Oct 2023 and classified Class II, with 1 product record.
FDA defines Class II as 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. 59% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Dollar Tree Distribution, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Dollar Tree Distribution, Inc., Chesapeake, VA.
Reason for recall
"CGMP Deviations: OTC products were stored outside of labeled temperature requirements."
Distribution
"Nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0045-2024 | Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores. | 4,261,383 units of various products | Class II | Ongoing | 25 Oct 2023 |
Context
Other enforcement events for Dollar Tree Distribution, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Feb 2022 | Medical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, | Device | Class II | 1 |
| 18 Feb 2022 | All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mi | Drug | Class II | 1 |
| 18 Feb 2022 | Food products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri | Food | Class II | 2 |
| 21 Dec 2012 | Candy Canes, Peppermint Flavor, 5 oz boxes, packed 12 individually candy canes/box, and labeled in part ***Distributed b | Food | Class II | 2 |
All 5 events for Dollar Tree Distribution, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP Deviations: OTC products were stored outside of labeled temperature requirements."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.