How do you run a mock recall for medicines, and how often is one required?

1How often a mock recall is required.

EU GMP sets no number for manufacturers. The only number in these texts is in EU good distribution practice: at least once a year, for wholesale distributors and for manufacturers that distribute their own products.¹

A frequency you can defend: evaluate at least once a year, because annual is the only number in these texts and GDP holds your EU distributors to it, and you too if you distribute your own products. Alternate office-hours and out-of-hours starts, and run an extra exercise after a change of distributor, ERP system or warehouse. Record the reasoning, because 8.30 asks for the evaluation to be justified.²¹

2How to run a mock recall: steps and template.

1. Choose a hard case, not the latest batch, from the menu below. FDA suggests mock recalls for firms that anticipate complex recalls, and gives “a large or multi-layered distribution chain” as one complication.¹¹ Write the scenario, assumed hazard and recall depth into a protocol.¹²
2. Start without notice, since a recall must be able to start “promptly and at any time”, and alternate office-hours and out-of-hours starts. Log the start time.²
3. Block your own stock of the batch, on site and at contract warehouses. MHRA has cited a site with “no procedural instruction to ensure that any in-house stocks of product potentially affected by a recall are quarantined”.¹³
4. Trace back to the components and API lots in the batch, and note other batches that used them.¹⁴
5. Trace forward to every consignee, exports and samples included.¹⁰²
6. Contact each direct consignee on the numbers held, mark the contact as an exercise, and ask for stock on hand and onward distribution.¹¹⁵
7. Reconcile the quantity delivered against what consignees hold and have sold on.²
8. Score each step against the targets in your procedure, write the report and raise CAPA.²

Rotate the scenario so each exercise tests a different weak point:

The protocol and report record these fields. Each line names the requirement it tests.

None of these rules says how long a mock recall should take, so your procedure must set targets; MHRA has cited a recall procedure that “did not define maximum timelines for key steps”.¹³ Example targets a site might set itself:

2.1Where unaccounted packs usually are.

When the reconciliation will not close, look where stock leaves the main sales records. The regulators name most of these places themselves:

• Exports and medical samples, which distribution records must include.²¹
• Stock in transit, and samples removed by quality control, which Health Canada says the records must also trace.⁵
• Returns on their way back, which GDP handles under a written, risk-based returns process.¹
• Damaged or destroyed stock: GDP requires records of all destroyed product, but a record without the batch number cannot close a batch reconciliation.¹
• Transfers between your own or contract warehouses, where records should show “the actual location of the product”.¹
• Packs without safety features at distributors, whose records need batch numbers only for products bearing them.¹

3Example: a mock recall of Batch 26-041.

Example, invented for illustration. Product B 20 mg tablets, Batch 26-041: 60,000 packs, released on Monday 14 September 2026. The scenario is a dissolution failure on stability, assumed to need a recall to wholesale level. QA starts the exercise unannounced at 19:30 on Saturday 17 October 2026, outside office hours.

The batch record names API lot A-2604, which also went into Batch 26-044, still in QC testing; a real recall scoped on the API would put 26-044 on hold too. The trace forward comes from the distribution records.

The finding is a contact detail, not a trace: EU GMP expects distribution records to hold phone numbers inside and outside working hours.² The report closes the exercise in the terms 8.29 and 8.30 use:

4What inspectors cite.

In MHRA’s 2019 GMP deficiency data, 8.30 was the most cited clause in Chapter 8: 44 citations at 44 of the 258 sites in the dataset, 14 major and 30 other, none critical. The next, 8.10, had 17.¹⁸ In 2016, complaints and recalls had the fourth most critical deficiencies of any group in MHRA’s GMP inspections of dosage-form sites: 11 critical, 80 major and 110 other. Among MHRA’s examples:¹³

There is no requirement to perform an out of normal working hour test of the recall system.

The mock recall process did not effectively challenge the supply chain and did not require a reconciliation or report to consider the effectiveness of the recall.

MHRA’s distribution inspectors found the same weakness at a wholesaler:¹⁹

The process for regularly assessing the effectiveness of recall activities lacked sufficient detail so as to permit staff to follow the process consistently and for the Responsible Person to make an objective assessment as to the effectiveness of recall arrangements.

FDA’s compliance program lists “Finished product distribution records by lot” among the areas investigators cover when they inspect the materials system.²⁰ Its warning letter of 7 April 2026 to Lexia LLC of Franklin, Tennessee, which makes an over-the-counter topical pain relief product, cited a quality unit failure (21 CFR 211.22), with this among the things the firm failed to ensure:²¹

Establishment of a system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary (21 CFR 211.150(b)).

On 7 August 2026 FDA cited missing lot traceability at Safrel Pharmaceuticals of New Jersey, which holds, labels and distributes over-the-counter drugs, and rejected its promised fix because it did not show the new system could achieve lot-level traceability.²² Each finding maps to a template line: the out-of-hours start, a reconciliation that runs through the consignees, targets precise enough for someone else to judge, and lot numbers on every shipping record.

5Decisions you will face.

Records that let the trace run in minutes are covered in lot genealogy; the complaint that often starts a real recall, in complaint handling.

6How it runs in Seal.

In Seal, a recall is one case, from the signal and health-hazard evaluation through genealogy-based scope, each consignee’s notification and response, effectiveness checks and a running reconciliation, so a mock recall exercises the same records a real one would.

Neil can trace a material lot through production to the downstream batches recorded against it, keeping unresolved links visible rather than hiding them. Your quality team decides product impact and any market action.