Drug recall and shortage literacy: recall classes, Enforcement Reports, checking a lot, and what shortage status means

Two FDA lists that answer different questions

When a medicine is in the news, two words tend to appear together: recall and shortage. They come from different parts of FDA, are defined by different rules, and live in different databases.

A recall is about specific product that has a problem. FDA's regulations define a recall as "a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure" (21 CFR 7.3(g)). Recalls are tracked by lot in the weekly FDA Enforcement Report.

A shortage is about supply. FDA's drug shortage FAQ explains that the FD&C Act defines a drug shortage as "a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug," and that FDA tracks shortages at the national level. Shortages are tracked in the FDA Drug Shortages Database.

The two can be connected. A large recall can remove enough product to cause a shortage, and FDA's FAQ says manufacturing and quality problems are the most common reason for shortages. But a shortage listing is not a finding that anything is wrong with the product in your hand, and a recall of one firm's lots says nothing about whether the medicine is in short supply.

GLPWiki's 503A versus 503B guide covers the full GLP-1 compounding and shortage history. This page focuses on how to read the two lists themselves and keeps the shortage timeline brief.

Recall, market withdrawal, stock recovery and correction

Part 7, subpart C of FDA's regulations sets out recall policy for all FDA-regulated products. Its definitions in 21 CFR 7.3 decide what counts as a recall at all.

• Recall (7.3(g)): removal or correction of a marketed product that FDA considers violative and would take legal action against. "Recall does not include a market withdrawal or a stock recovery."
• Correction (7.3(h)): "repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location." A relabeling can be a recall even if no product moves.
• Market withdrawal (7.3(j)): removal or correction of a distributed product involving "a minor violation that would not be subject to legal action" by FDA, or no violation at all, such as normal stock rotation. FDA's definitions page gives the example of a product removed because of tampering "without evidence of manufacturing or distribution problems."
• Stock recovery (7.3(k)): removal or correction of product that "has not been marketed or that has not left the direct control of the firm," with no portion of the lot released for sale or use.
• Recalling firm (7.3(i)): the firm that starts the recall or, for an FDA-requested recall, the firm primarily responsible for making and marketing the product. For a compounded product this is the pharmacy or outsourcing facility, not the maker of an approved brand.
• Consignee (7.3(n)): "anyone who received, purchased, or used the product being recalled" — wholesalers, pharmacies, clinics and, at consumer level, patients.

Class I, II and III: what the numbers mean

Every recall gets a numerical class after an FDA health hazard evaluation. Under 21 CFR 7.41, an ad hoc committee of FDA scientists considers whether any disease or injury has already occurred, which populations are exposed and which are most at risk, how serious the hazard is, how likely it is to occur, and its immediate or long-range consequences.

The resulting class, defined in 7.3(m), indicates "the relative degree of health hazard presented by the product being recalled."

• Class I: "a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death." FDA's drug recall page says these recalls are "generally conducted at the consumer level" and that Class I notifications generally include instructions for patients.
• Class II: use or exposure "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." FDA says these are generally conducted at the retail level.
• Class III: use or exposure "is not likely to cause adverse health consequences." FDA's examples include minor labeling errors, defective packaging or incorrect expiration dates; these are generally conducted at the wholesale level.
• Not yet classified: since June 15, 2017, the Enforcement Report has listed recalls before FDA finishes its hazard assessment, so the public hears sooner. The entry is updated with a class later.

How a recall runs: depth, public warnings, effectiveness checks and status

Each recall follows a recall strategy (21 CFR 7.42), written by FDA for an FDA-requested recall or by the firm for a firm-initiated one. The strategy weighs the hazard evaluation, how easy the product is to identify, how obvious the defect is to users, how much product remains unused, and "continued availability of essential products" — a reminder that recalls and supply are linked from the start.

• Depth: how far down the distribution chain the recall reaches — wholesale level, retail level, or consumer or user level (7.42(b)(1)).
• Public warning: reserved "for urgent situations where other means for preventing use of the recalled product appear inadequate" (7.42(b)(2)). That is why many recalls never get a press release.
• Effectiveness checks: verifying that consignees got the notice and acted. Levels run from A (100% of consignees contacted) through B (more than 10% and less than 100%), C (10%), D (2%) to E (no effectiveness checks) (7.42(b)(3)).
• Recall communications (7.49): should identify "the product, size, lot number(s), code(s) or serial number(s)," explain the reason and hazard, and say what to do. Envelopes and letters are marked "urgent" for Class I and II recalls.
• Status reports (7.53): firms generally report progress to FDA every 2 to 4 weeks — how many consignees were notified, responded, and returned product.
• Status in the Enforcement Report: Ongoing (in progress), Completed (the firm has retrieved all product that could reasonably be recovered or finished corrections), or Terminated (FDA has determined all reasonable efforts were made and proper disposition occurred, 7.55).

Reading an FDA Enforcement Report entry

Under 21 CFR 7.50, FDA publishes "a descriptive listing of each new recall according to its classification" in the weekly Enforcement Report. FDA's Enforcement Report page says it "includes all recalls monitored by FDA," classified or not yet classified. Market withdrawals and stock recoveries are excluded, and 7.50 allows FDA to delay public notice for certain drugs and devices when notice could cause "unnecessary and harmful anxiety" and patients should first consult their physicians.

The report can be browsed by week, searched by product description, code information, class, firm, status, recall number, reason and date, exported to CSV, or queried through an API (also mirrored by openFDA's drug enforcement endpoint). Since July 24, 2018, a History feature shows later changes to an entry's classification, reason, code information or product description. You can subscribe to e-mail alerts by product type or keyword.

FDA's Enforcement Report definitions describe each field. The ones that matter most for reading an entry:

• Recall Number and Event ID: tracking numbers. One event (one firm's recall action) can include many products, each with its own recall number.
• Classification: Class I, II, III or Not Yet Classified, plus Center Classification Date.
• Product Description: the product as labeled, often including the NDC. For compounded products this may show an internal number rather than a listed NDC.
• Code Information: "a list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling." This is the field to match against your package.
• Reason for Recall: how the product is defective, in FDA's wording (for example, "Lack of Assurance of Sterility" or a labeling mix-up).
• Product Quantity and Distribution Pattern: how much product and where it was initially shipped. FDA notes that later distribution by consignees "may not be included."
• Voluntary/Mandated: "Voluntary: Firm initiated" covers most drug recalls; "Mandated" means a statutory recall authority, court order or FDA order.
• Recall Initiation Date and Status: when the firm began notifying consignees, and where the recall stands now.

Checking a product by lot: a literacy walkthrough

FDA's consumer advice is simple: if your medicine may have been recalled, "check the lot number on the label of your medicine to see if it matches the lot number of the recalled medicine in the notification." Recalls are lot-specific because 21 CFR 7.59 asks firms to code products for "positive lot identification" and keep distribution records.

• Step 1 — Read the package. From the carton or container label, note the product name, the manufacturer, labeler or compounding pharmacy, the NDC (if any), the lot number and the expiration or beyond-use date. GLPWiki's carton and container label guide shows where each one is printed.
• Step 2 — Search the Enforcement Report by product description and by recalling firm. Search more than one spelling: brand name, established name, and the firm's name.
• Step 3 — Open each matching entry and compare the Code Information lot list with your lot, character by character. Partial matches and look-alike lot formats are common.
• Step 4a — If your lot is listed, read the classification, reason and status, follow the recall notice from the firm or pharmacy, and talk to a pharmacist or prescriber before stopping or changing anything.
• Step 4b — If your lot is not listed, the product is not part of that recall. That is a narrower statement than "this product is fine": recalls only cover problems that have been found, and unapproved or counterfeit products may never appear in a recall at all.
• Step 5 — Report suspected problems. Product quality problems and adverse events go to MedWatch, with the lot and NDC from the package; GLPWiki's MedWatch and FAERS guide explains what a report asks for.

What GLP-1 entries in the Enforcement Report look like

GLPWiki queried openFDA's drug enforcement endpoint on November 1, 2026, searching product descriptions for the ingredient names. These are record counts, not a complete audit: one recall event can produce many product records, and descriptions that misspell or omit the ingredient will be missed.

• Semaglutide: 57 records, all Class II, all "Voluntary: Firm initiated," from 15 recalling firms. Stated reasons: lack of assurance of sterility (30), particulate matter (13), lack of processing controls (6), potency problems (4), and a few cGMP or temperature issues. Most records came from compounding pharmacies or outsourcing facilities. Five involved approved brand products: three from the approved-product manufacturer (a 2021 entry for temperature-abused product samples and two January 2026 entries for particulate matter found in pens) and two from a distributor for temperature exposure in storage or shipping. Two more covered semaglutide bulk ingredient labeled for compounding use, recalled by an overseas supplier for cGMP deviations.
• Tirzepatide: 28 records (27 Class II, 1 Class I), all firm-initiated, from 9 recalling firms, all compounders. Stated reasons: lack of assurance of sterility (19), lack of processing controls (7), one potency issue, and one labeling mix-up.
• The one Class I tirzepatide record (2024) was a labeling mix-up: a compounded product labeled as tirzepatide that actually contained testosterone cypionate. It shows why FDA treats a wrong-product label as a serious hazard.
• Status: most of these records were listed as Ongoing on the query date. Ongoing does not mean the product is still being sold; it means FDA has not recorded completion or termination.

What the FDA Drug Shortages Database says

FDA's Drug Shortages Database lists current and resolved shortages and discontinuations reported to FDA, searchable by generic name or active ingredient. The FD&C Act section 506E (21 U.S.C. 356e) requires FDA to keep an up-to-date shortage list that includes the drug name and NDC, each manufacturer, the reason for the shortage chosen from set categories, and the estimated duration.

• Currently in Shortage: FDA has determined national supply is not meeting current or projected demand and is working with manufacturers to mitigate it.
• Resolved: FDA's database says a drug receives Resolved status when the Drug Shortages Staff "determines that the market is covered" — supply is available from at least one manufacturer to cover total market demand, though "some manufacturers may not have all presentations available."
• Discontinuation: a manufacturer has notified FDA that it is permanently stopping a product. Section 506C requires notice at least six months in advance for certain drugs, or as soon as practicable, and FDA's FAQ says notice of a discontinuance or interruption must come no later than five business days after it occurs.
• Manufacturer "available" notes: FDA's GLP-1 page warns that when a presentation is noted as available, that "is not an FDA determination that the shortage has been resolved."
• Reason categories in 506E: good manufacturing practice compliance, regulatory delay, active or inactive ingredient shortage, discontinuance, shipping delay, and demand increase.

The GLP-1 shortage timeline, briefly

FDA's page on compounding policy as GLP-1 supply stabilized is the primary chronology. In short:

• 2022: semaglutide and tirzepatide injection products entered FDA's shortage list "due to increased demand."
• October 2, 2024: FDA determined the tirzepatide injection shortage was resolved. After litigation the decision was remanded for reevaluation, and on December 19, 2024 FDA issued a new decision that the shortage was resolved.
• February 21, 2025: FDA determined the semaglutide injection shortage was resolved, after confirming the manufacturer's supply and capacity could meet present and projected national demand.
• 2025: FDA's time-limited enforcement-discretion windows for compounders ended — for tirzepatide, February–March 2025 (503A after a March 5 court decision; 503B on March 19), and for semaglutide, after an April 24 court decision for 503A and on May 22 for 503B.
• April 1, 2026: FDA stated that tirzepatide and semaglutide "do not currently appear on the 503B bulks list or on FDA's drug shortage list."
• November 1, 2026 (GLPWiki check): the Drug Shortages Database listed liraglutide injection as Currently in Shortage, with a separate liraglutide discontinuation entry; semaglutide injection and tirzepatide injection did not appear as current shortages. Check the live database before relying on any date-stamped statement, including this one.

Why shortage status matters for compounding

Shortage status is not just a supply statistic for GLP-1 medicines; it changes which compounding conditions apply. FDA's page on compounding when drugs are on the shortage list says that when an approved drug is on the list, "some federal law restrictions may not apply, such as restrictions on compounding drugs that are essentially copies of approved drugs. However, other conditions and requirements remain."

• 503A (state-licensed pharmacies and physicians): section 503A restricts compounding, regularly or in inordinate amounts, of drugs that are essentially copies of commercially available drugs. FDA says a drug "is not considered to be commercially available if it is on FDA's drug shortages list," and that when a shortage is resolved, FDA "generally considers the drug to be commercially available." All other 503A conditions, including a valid prescription for an individual patient, still apply.
• 503B (outsourcing facilities): section 503B restricts making essentially a copy of an approved drug, but that limit does not apply to identical or nearly identical copies of a drug on the shortage list. Separately, outsourcing facilities may compound from bulk drug substances only if the substance is on the 503B bulks list or the drug is on the shortage list "at the time of compounding, distribution and dispensing."
• What does not change: compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness or quality before marketing. FDA recommends that patients be prescribed an FDA-approved drug when available and appropriate.
• Professional guidance: the American Diabetes Association's 2025 statement notes that GLP-1 and GIP/GLP-1 shortages led in part to compounded products that bypass regulatory measures, and that these products continued to be heavily marketed even as shortages resolved.

Common misreadings

These are the mistakes that show up most often when recall and shortage records are quoted online.

• "Drug X was recalled" — usually means specific lots from one firm were recalled for a stated reason. Check which firm, which lots and which class.
• "Class I means the drug is dangerous" — Class I describes the hazard of the recalled product for the stated defect, such as a wrong-product label, not the safety profile of the medicine as approved.
• "No press release, so no recall" — most recalls appear only in the Enforcement Report.
• "The shortage is over, so compounded versions are banned" or "it's on the shortage list, so anything goes" — neither slogan is accurate. Shortage status changes some conditions; the rest still apply, and FDA's own statements are dated.
• "My pharmacy is out, so it's a shortage" — local outages are often distribution issues. Check the database.
• "Not on the recall list, so it's safe" — a lot check only shows that a product is not part of a known recall.

Scope, disclaimer and review date

This page explains how FDA recall and drug shortage records work and how to read them. It does not provide doses, schedules, injection or device instructions, product or pharmacy recommendations, or individual medical advice, and nothing here suggests starting, stopping or changing any medicine. If you think a medicine you have is recalled, follow the recall notice and talk with a pharmacist or prescriber; for a medical emergency, call 911 or your local emergency number.

Last reviewed: November 1, 2026. Recall and shortage records change weekly; verify with FDA's Enforcement Report, the Drug Shortages Database and FDA's compounding pages before relying on any statement here.