FDA Drug Regulatory Intelligence

Manufacturer regulatory signals

This page aggregates the U.S. FDA recall and shortage records indexed by this site into a manufacturer-level view. The counts shown are coverage-limited activity signals — they are not quality ratings, and this page offers no medical advice.

What this manufacturer view shows

Individual recall and shortage records each name a firm: the recalling firm on an enforcement report, or the reporting company on a shortage entry. By aggregating across the indexed datasets, this page builds a per-firm summary showing how many recall records and how many shortage records reference that firm, the date and type of the firm's most recent record, and links through to the underlying entries. For regulatory-affairs, supplier-risk and procurement teams, this turns a stream of individual records into a navigable, firm-centric index — a finding aid for locating a company's footprint across the public FDA datasets indexed here.

The firm names are normalised directly from the source fields, with common legal-suffix variants (for example, "Incorporated" and "Inc", or "Limited" and "Ltd") collapsed so that the same company is not split across several near-duplicate rows. We never invent or infer a firm name: records whose source does not identify a firm are simply not represented in this view, rather than being attributed to a guessed company.

Why counts are not quality ratings

This is the most important caveat on the page, and it is deliberate. The counts here measure one narrow thing: how often a firm appears in the specific FDA recall and shortage records that this site has ingested, over the window those datasets cover. They are coverage-limited activity signals. They are not reputational scores, not safety rankings, and not assessments of a company or its products.

Several structural reasons make a raw count a poor proxy for quality. Larger firms with broader portfolios naturally appear in more records than smaller ones, regardless of conduct. Recalls are a sign of a functioning post-market surveillance system, and a firm that promptly initiates recalls is participating in that system as intended. Shortages frequently arise from supply-chain and manufacturing-capacity factors that are not specific to one company. And the ingested window is finite, so counts reflect a slice of time rather than a complete history. For all these reasons, a higher or lower count should be read only as "appears more or less often in these particular public records" — nothing more.

Manufacturer signals table

Manufacturer / firmRecallsShortagesLatest recordLatest type
Guardian Drug Co. Inc.2302026-06-10recall
Carefusion 213, LLC1702026-07-22recall
Baxter Healthcare0142026-08-20shortage
Dabur India Ltd1402026-06-24recall
Major Pharmaceuticals1202026-07-29recall
Bell Pharmaceuticals, Inc1102026-07-22recall
Ascend Laboratories, LLC902026-08-05recall
Blaine Labs Inc802026-07-08recall
Rohto-mentholatum (vietnam) Co., Ltd.802026-07-29recall
Teva Pharmaceuticals Usa, Inc172026-08-20shortage
Accord Healthcare, Inc.162026-08-20shortage
Keystone Industries702026-06-24recall
Wells Pharma OF Houston LLC702026-05-06recall
Amphastar Pharmaceuticals, Inc.062026-08-18shortage
Fresenius Kabi Usa, LLC602026-07-29recall
Gasco Industrial Corp.602026-07-15recall
Lannett Company Inc.332026-08-20shortage
Mylan Institutional, A Viatris Company062026-08-20shortage
Sagent Pharmaceuticals152026-08-21shortage
Sun Pharmaceutical Industries Inc602026-07-08recall
Amgen, Inc.502026-07-01recall
Lupin Pharmaceuticals Inc.322026-08-18shortage
Otsuka Icu Medical LLC052026-08-17shortage
Specgx LLC022026-08-20shortage
Asclemed Usa Inc.402026-07-29recall
Bristol Myers Squibb002026-08-18approval
Pai Holdings LLC402026-06-24recall
Reliance Life Sciences Private Ltd402026-07-15recall
Sandoz Inc132026-08-20shortage
Ajanta Pharma Ltd.302026-05-13recall
Alvogen022026-08-20shortage
Ascent Pharms Inc002026-08-14approval
B Braun Medical Inc302026-05-13recall
Breckenridge Pharmaceutical, Inc.302026-06-17recall
Cipla Usa, Inc.302026-07-08recall
Golden State Medical Supply Inc.302026-06-17recall
Hikma002026-08-18approval
Par Health Usa, LLC122026-08-20shortage
Sandoz002026-08-13approval
Zydus Pharmaceuticals (usa) Inc302026-08-12recall
Actavis Elizabeth002026-08-14approval
Ajanta Pharma Usa Inc202026-07-01recall
Alcon Research LLC202026-05-06recall
American Regent, Inc.112026-08-18shortage
Amerisource Health Services LLC202026-05-27recall
Amneal Pharms002026-08-14approval
Ani Pharmaceuticals, Inc.202026-07-01recall
Avet Pharmaceuticals, Inc.022026-08-18shortage
Central Admixture Pharmacy Services Inc202026-08-12recall
DR Reddys Labs SA002026-08-14approval
Elite Laboratories, Inc.022026-08-20shortage
Epic Pharma, LLC022026-08-20shortage
Ethypharm002026-08-14approval
Fresenius Medical Care Holdings, Inc.202026-05-13recall
Glenmark Pharmaceuticals Inc., Usa202026-08-05recall
Haleon US Holdings LLC202026-06-17recall
Inforlife SA022026-08-18shortage
Integradose Compounding Services LLC202026-06-24recall
Janssen Pharms002026-08-11approval
JB Chemicals And Pharmaceuticals Ltd202026-07-29recall
Msn002026-08-14approval
Mylan Technologies002026-08-14approval
Oxford Pharms002026-08-13approval
Rhodes Pharms002026-08-14approval
Safecor Health, LLC202026-05-27recall
Sun Pharm002026-08-14approval
Sunny Pharmtech Inc.202026-08-12recall
Teva Pharms Usa002026-08-17approval
The Harvard Drug Group LLC202026-07-01recall
Thea Pharma, Inc.202026-05-06recall
Zydus Pharms002026-08-11approval
Abbvie Inc.102026-06-03recall
Accord Biopharma Inc102026-07-08recall
Accord Hlthcare002026-08-17approval
Acella Pharmaceuticals, LLC102026-05-13recall
Alembic002026-08-13approval
Alignscience Pharma002026-08-11approval
Alkem Labs Ltd002026-08-14approval
Almatica002026-08-17approval
AM Regent002026-08-13approval
Amneal Pharmaceuticals, LLC102026-06-17recall
Annora Pharma002026-08-17approval
Annora Pharma Private Ltd102026-07-01recall
Astrazeneca AB002026-08-11approval
Aurobindo Pharma002026-08-11approval
Aurobindo Pharma Ltd002026-08-11approval
Aurobindo Pharma Usa Inc102026-08-12recall
Aveva Drug Delivery Systems, Inc.102026-06-03recall
Azurity Pharmaceuticals, Inc012026-08-20shortage
Barr002026-08-14approval
Baxter Hlthcare Corp002026-08-14approval
Beekeeper's Naturals Usa Inc.102026-06-17recall
Biocon Biologics Inc002026-08-14approval
Biomed Laboratories, Llc.102026-07-15recall
Bionpharma Inc.102026-07-29recall
Boehringer Ingelheim002026-08-14approval
Boehringer Ingelheim Pharmaceuticals, Inc.102026-07-08recall
Central Admixture Pharmacy Services, Inc (caps) Los Angeles102026-05-13recall
Cerveau Technologies Inc A Lantheus Co002026-08-13approval
Cheplapharm Arzneimittel Gmbh012026-08-17shortage
Chiesi Usa, Inc.102026-07-22recall
Creekwood Pharms002026-08-14approval
Cspc Ouyi002026-08-11approval
Cumberland Pharmaceuticals Inc.012026-08-18shortage
Curium US LLC012026-08-19shortage
Delcath Systems Inc002026-08-12approval
Difgen Pharms002026-08-14approval
Direct RX102026-07-01recall
DR Reddys Labs Ltd002026-08-18approval
Edenbridge Pharms002026-08-14approval
Edw Pharma, Inc. (formerly Italfarmaco Pharma, Inc.)012026-08-17shortage
Elevate Oral Care102026-07-01recall
Endo Usa, Inc.102026-05-20recall
Eugia US LLC102026-06-10recall
Fresenius Kabi Usa002026-08-17approval
Glenmark Pharms Ltd002026-08-18approval
Glenmark Speclt002026-08-17approval
Granules002026-08-11approval
Granules Pharmaceuticals Inc.012026-08-20shortage
Harrow Eye LLC102026-04-29recall
Hetero Labs Ltd V002026-08-17approval
Hikma Pharmaceuticals Usa Inc102026-05-06recall
Hoffmann-la Roche002026-08-14approval
HQ Specialty Pharma012026-08-20shortage
Indicus Pharma002026-08-11approval
Indivior002026-08-14approval
Inventia Healthcare Ltd102026-06-24recall
Janssen Pharmaceuticals012026-08-19shortage
Jubilant Generics002026-08-17approval
Laboratorios Atral012026-08-17shortage
Lannett Co Inc002026-08-14approval
Laurus002026-08-11approval
Leading Pharma, LLC102026-04-29recall
Lib Therapeutics, Inc.002026-08-18approval
Long Grove Pharmaceuticals LLC012026-08-18shortage
Lupin002026-08-14approval
Mckesson102026-07-08recall
Medefil, Inc.012026-08-17shortage
Merck Sharp Dohme002026-08-12approval
Micro Labs Usa Inc102026-08-05recall
Msn Laboratories Private Ltd012026-08-21shortage
Mylan Pharmaceuticals Inc102026-08-05recall
Mylan Pharmaceuticals Inc., A Viatris Company012026-08-20shortage
Mylan Pharms Inc002026-08-11approval
Mylan Specialty, A Viatris Company012026-08-20shortage
Nostrum Pharms LLC002026-08-11approval
Novadoz Pharmaceuticals LLC012026-08-17shortage
Novast Labs002026-08-11approval
Novitium Pharma002026-08-12approval
Novo Nordisk, Inc.012026-08-17shortage
Oasis Medical, Inc.102026-05-20recall
Onesource Specialty Pharma Ltd102026-07-15recall
Onesource Specialty Pte Ltd012026-08-18shortage
Organon002026-08-17approval
Padagis US LLC102026-07-22recall
Pai Holdings Pharm002026-08-18approval
Pfizer002026-08-17approval
Pharmaand Gmbh (pharma&)012026-08-17shortage
Ppi-dac002026-08-18approval
Precision Dose Inc.102026-07-29recall
Premier Dental Products Co102026-04-29recall
Preye LLC102026-07-01recall
Qingdao Baheal Pharm002026-08-11approval
Quagen002026-08-14approval
Quva Pharma, Inc.102026-07-15recall
Regcon Holdings002026-08-11approval
Regeneron Pharmaceuticals, Inc002026-08-19approval
Rising002026-08-17approval
Rising Pharma Holding, Inc.102026-07-29recall
Rubicon Research002026-08-14approval
Saptalis Pharms002026-08-11approval
Scope Health102026-05-06recall
Seasons Biotechnology (taizhou) Co Ltd002026-08-17approval
Shimoga Chemicals102026-07-15recall
Spectra Medical Devices, LLC102026-06-10recall
Sterinova Inc002026-08-18approval
Sun Pharm Inds (in)002026-08-11approval
Supernus Pharmaceuticals, Inc.102026-07-29recall
Takeda Pharms Usa002026-08-11approval
Teyro Labs012026-08-18shortage
Trigen Laboratories, LLC012026-08-19shortage
Twi Pharms002026-08-12approval
Ucb Biosciences Inc.102026-05-27recall
Unichem Pharmaceuticals Usa Inc.102026-05-13recall
Vertical Pharmaceuticals, LLC012026-08-19shortage
Water-jel Technologies, LLC102026-05-06recall
Wes Pharma Inc002026-08-14approval
WG Critical Care012026-08-18shortage
Wisconsin Pharmacal Company102026-05-27recall
Zep Inc102026-06-17recall
Zydus002026-08-17approval
Zydus Lifesciences002026-08-11approval
Zydus Pharms Usa002026-08-11approval

Counts are not quality ratings. They are coverage-limited activity signals showing how often a firm appears in the indexed FDA records — not judgements about the firm or its products.

How to use the manufacturer view responsibly

The right way to read this view is as a navigation aid into the underlying FDA records. If a firm you are researching appears here, the counts tell you how many indexed recall and shortage records reference it, and the links take you to those specific records and onward to the official source. That is genuinely useful for supplier-risk screening, regulatory monitoring and procurement diligence — but only when the counts are understood for what they are. They are a starting point for investigation against the authoritative record, not a conclusion in themselves, and certainly not a substitute for a firm's full regulatory history or for direct verification with the FDA.

The wrong way to read this view is as a league table. Because larger and more diversified firms naturally appear in more records, because recalls reflect a working surveillance system rather than necessarily a failing one, and because the ingested window is finite, ranking companies by raw count would be misleading. For that reason the table is sorted only to surface the most active firms in the indexed data, with an explicit caveat repeated on every manufacturer page that the counts are not quality ratings. This framing is deliberate and is part of the site's no-medical-advice, no-unsupported-judgement policy.

Full regulatory profiles (36)

Firms with at least 3 indexed records and at least one recall or shortage among them. Each has enough source-derived history to stand as a profile: record counts by classification and status, the products named, the years covered, and links to every underlying record.

Firms with limited coverage (157)

Firms appearing in fewer than 3 indexed records, or only in approval data. Their pages are published so the records stay reachable and verifiable, and they link on to the underlying FDA records — but they carry a noindex directive and are left out of the sitemap. A single appearance of a company name is not a regulatory history, and presenting it as one would overstate what the data supports. A firm crosses into a full profile automatically once further records reference it.

157 firms with limited coverage

Source & provenance

Official source
https://open.fda.gov/apis/drug/enforcement/
Source dataset
openFDA (enforcement + shortages)
Publication date
Not available
Ingested
2026-08-22

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.

Frequently asked questions

What is a manufacturer regulatory signal?

It is a coverage-limited count of how often a firm appears in the FDA recall and shortage datasets indexed by this site, plus the date and type of its most recent record. It is an administrative activity signal, not a quality rating.

Does a high count mean a manufacturer is bad?

No. Counts reflect how frequently a firm shows up in these specific public records over the ingested window. Recalls and shortages are routine parts of pharmaceutical regulation. A count is not a judgement about a company or its products and must never be read as one.

Where do the firm names come from?

They are normalised directly from the recalling-firm and reporting-company fields in the FDA records. We never invent or infer a manufacturer name; firms with no identifiable name in the source are simply not represented.