On Sept. 2, 2026, FDA's weekly Enforcement Report1 carried a dozen recall entries for levothyroxine tablets. One of them, recall D-0785-2026, covered the 200 mcg strength for subpotency. It named two lot numbers for 90-count bottles and two more for 1,000-count bottles, each paired with an expiration date, and FDA classified it Class II with nationwide distribution.
Those lot numbers decide whether a recall touches a particular bottle, and they seldom appear on the label a patient carries home. Levothyroxine has turned up often this year. GxRadar's count of openFDA enforcement records6 finds 30 levothyroxine recall entries posted between Jan. 21 and Oct. 28, 2026, and 28 of them cite a subpotent drug.
Most recalls like these never reach the evening news. FDA says that not all recalls are announced on FDA.gov or in the news media4, and the records bear that out. Of the 704 drug recall entries FDA posted from Jan. 1 through Oct. 28, 2026, only 28 began with a press release alone; 493 began with a letter from the recalling firm to its customers.
Where FDA publishes drug recalls
FDA keeps two public records. The first is its Recalls, Market Withdrawals, and Safety Alerts page3, which reposts company press releases and other public notices. FDA notes on that page that not all recalls have press releases or appear there, and that entries stay up for three years before moving to an archive.
The second record is the complete one. Under 21 CFR 7.505, FDA publishes a weekly listing of each new recall by classification. Since June 15, 2017, the Enforcement Report has also listed recalls whose hazard assessment is still under way, labelled "not yet classified." The Enforcement Report application can be searched by product description, code information, recall class, status, reason and date, according to FDA's definitions page2, which also explains each field. A free subscription, described on the Enforcement Reports page1, sends email for all recalls, for drugs only, or for keywords such as a drug name.
Those same records feed the openFDA API that powers GxRadar's recall tracker. A count by class6 for 2026 so far shows how the year has gone.
| Class | FDA definition (21 CFR 7.3) | Usual recall depth, per FDA | Entries, Jan. 1 to Oct. 28, 2026 |
|---|---|---|---|
| Class I | Reasonable probability of serious adverse health consequences or death | Generally the consumer level | 38 |
| Class II | May cause temporary or medically reversible harm; serious harm is remote | Generally the retail level | 611 |
| Class III | Not likely to cause adverse health consequences | Generally the wholesale level | 54 |
| Not yet classified | FDA has found a recall but has not finished its hazard assessment | Varies | 1 |
| Total | 704 |
Counts are from openFDA drug enforcement data last updated Oct. 28, 2026. Depth descriptions come from FDA's consumer guidance on recalls.
How a recall notice names a product
Two fields do most of the work. "Product description" gives the drug name, strength, dosage form and package size, and often the National Drug Code. "Code information" is, in FDA's words, a list of "all lot and/or serial numbers, product numbers, expiration dates" and similar marks that appear on the product or its labeling.
In GxRadar's tally of the 704 entries from 2026, the product description included an NDC in 587 (83 percent) and the code information named at least one lot in 663 (94 percent). The NDC identifies the labeler, the product and the package size. The lot number identifies one production batch. Recalls nearly always cover specific lots, so a matching drug name and strength by themselves do not put a bottle inside a recall.
Repackaged medicines add a layer. Several 2026 levothyroxine entries for unit-dose blister cartons list a "bag lot" and a separate "blister lot," because the repackager's codes sit on top of the original manufacturer's. The distribution field narrows little. It read nationwide in 666 of the 704 entries. Our field-by-field guide to a recall notice walks through the rest.
Matching a notice to the medicine at home
Start with the pharmacy label, which shows the drug name, strength and dosage form and often the manufacturer. It usually does not show a lot number. The pharmacist counted the tablets out of a larger stock bottle, and that bottle carries the lot and expiration date, as our guide to reading a prescription label explains.
If the label does show an NDC, or the medicine is still in a manufacturer's original package, compare it with the product description in the notice. FDA's NDC Directory7, which the agency says is updated daily, and the National Library of Medicine's DailyMed9 both look up a product by NDC. Formatting can trip people up. FDA-assigned NDCs are 10 digits in several layouts, while billing systems use what FDA's NDC format page8 calls the HIPAA standard 11-digit format, so the same code can appear with an extra zero in one segment.
For most prescription fills, the pharmacy's records close the gap. The dispensing system records which product went into each fill. Recall letters, meanwhile, move down the supply chain. Under 21 CFR 7.4911, a recalling firm notifies its direct accounts, which pass the notice to their own customers where appropriate, and the letter should identify "the product, size, lot number(s), code(s) or serial number(s)" so stock can be found quickly.
What FDA says to do when a lot matches
FDA's consumer guidance draws a line by class. Class I notices generally carry instructions for patients, and FDA recommends following the recalling company's instructions. For Class II and III recalls, FDA says "consumers can generally continue taking the medicine unless the recalling company provides other instructions," and adds that "in some instances, stopping your medicine may be more harmful to your health than continuing to take the recalled medicine." Its advice is to talk to a doctor or pharmacist with any question or concern.
That puts the pharmacist at the center. A short set of questions covers most situations:
- Which manufacturer's product, by NDC, did you dispense on my most recent fill?
- Does the lot from that fill appear on the recall notice?
- If it does, what does the recall ask pharmacies and patients to do, and do you have stock from a lot that is not affected?
- Does my prescriber need to weigh in, and will you contact them or should I?
FDA notes that recalling companies sometimes ask consumers to return product to the place of purchase, and that most retailers have return and refund policies for recalled products. If the pharmacist or prescriber says a supply should be discarded, our guide to disposing of unused medicines covers take-back options. Anyone who suspects a medicine caused harm, or spots a quality problem with no recall attached, can report it to FDA's MedWatch program10.
Keeping watch between refills
Two habits make later checks faster. One is keeping a note of the manufacturer and NDC for each fill, which a pharmacist can read from the dispensing record. The other is letting the weekly report come to you, through FDA's keyword subscription or GxRadar's live radar feed, which pulls new recall entries from openFDA. Our DailyMed walkthrough shows how to confirm what product a given NDC belongs to, and the pharmacist script has wording for the call.
The codes themselves will change. Under an FDA final rule, every NDC converts to a uniform 12-digit format on March 7, 20338. FDA does not intend to object to 10-digit codes on labels during a transition that runs through March 6, 2036, so for three years an older package and a newer one for the same product may carry the code in different forms.
Sources and notes
- FDA (2024). Enforcement Reports
www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports - FDA (2025). Enforcement Report Information and Definitions
www.fda.gov/safety/enforcement-reports/enforcement-report-information-and-definitions - FDA (2026). Recalls, Market Withdrawals, and Safety Alerts
www.fda.gov/safety/recalls-market-withdrawals-safety-alerts - FDA (2026). Understanding Drug Recalls: What to Know and What to Do
www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do - Cornell LII (2026). 21 CFR 7.50, Public notification of recall
www.law.cornell.edu/cfr/text/21/7.50 - openFDA (2026). Drug recall enforcement reports API
open.fda.gov/apis/drug/enforcement/ - FDA (2026). National Drug Code Directory
www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory - FDA (2026). National Drug Code Format final rule overview
www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/national-drug-code - National Library of Medicine (2026). DailyMed
dailymed.nlm.nih.gov/dailymed/ - FDA (2026). MedWatch: The FDA Safety Information and Adverse Event Reporting Program
www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program - Cornell LII (2026). 21 CFR 7.49, Recall communications
www.law.cornell.edu/cfr/text/21/7.49
Superscript numbers in the text link to these sources. GxRadar data (NADAC histories, recall and shortage counts) come from CMS and FDA files described on the sources page. Researched and drafted with AI assistance and checked against the sources above. Information current as of Nov 3, 2026 and may change. Spot an error? It will be corrected once confirmed.
Drug data in this article
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