Food, drugs, devices › AVKARE Inc.
Drug recall: Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50,
AVKARE Inc. (Pulaski, TN) initiated this drug recall on 28 May 2020; FDA lists 1 product record under event 85783, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 21% of the 342 drug enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 22 Oct 2021. Initiation: voluntary: firm initiated. AVKARE Inc. has 22 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
AVKARE Inc., Pulaski, TN.
Reason for recall
"Presence of Foreign Substance consistent with granules from desiccant packs used during storage"
Distribution
"Nationwide in the U.S."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1289-2020 | Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478. | 4124 bottles | Class III | Terminated | 10 Jun 2020 |
Context
Other enforcement events for AVKARE Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Presence of Foreign Substance consistent with granules from desiccant packs used during storage"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the U.S."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Oct 2021. "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.