Recall Readiness Checklist

Recall readiness is widely understood as the ability to take a product off the shelf. That is the easy half.

The operative question is: if one lot had to be withdrawn today, could you say where the rest of it went?

That question is answered entirely in advance, or not at all. There is no version of the record you can reconstruct after the fact.

Part 1 — Can you resolve the lot at all?

• [ ] Does every case on your shelves carry a readable lot identifier?
• [ ] Does that identifier match the lot on the receiving record?
• [ ] Does it match the lot on the certificate of analysis?
• [ ] Where they disagree, is the disagreement recorded as an open item rather than resolved by assumption?

Lot identity is the dependency underneath everything else. §300.301(d) requires sample and lot identification among the twelve fields on a certificate, and that identifier is what makes the chain resolvable.

Source: 25 TAC §300.301(d), adopted rules filed with the Secretary of State March 2, 2026 (TRD-202601066). In effect March 31, 2026.

Part 2 — Inbound

• [ ] Supplier and date of receipt recorded per lot, not per product
• [ ] Quantity received recorded per lot
• [ ] Certificate of analysis attached to the lot, not to the product line

Part 3 — Movement

• [ ] If you run more than one location, which lots went where, and when
• [ ] Transfers between locations recorded
• [ ] Any repacking or relabelling recorded — this is the step that most often severs the chain

Part 4 — Outbound

• [ ] Sales window per lot: first sold and last sold dates
• [ ] For any wholesale or B2B movement, which customer received which lot

Part 5 — The hour-long test

Pick one lot currently on your shelves. Trace it end to end: supplier record, receiving record, certificate, distribution, sales window.

Give yourself one hour.

Whatever you cannot answer in that hour is precisely what you would not be able to answer on the day it mattered — except that on the day, you would also be under time pressure and answering to someone else.

What this checklist does not do

It does not tell you whether a recall is required, who must be notified, or on what timeline. Those are situation-specific questions outside what a readiness checklist can answer. What it establishes is whether the underlying records would support any of those answers at all.