Prescription medicine
Atropine First approved as Atropen
Atropine (Atropen) is a prescription medicine with an FDA approval on record since 1973. FDA's NDC Directory lists it from 22 generic labelers, and pharmacies paid $7.74 per mL (Atropine 1% eye drops) in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
Check it at the source: the atropine FDA label on DailyMed (effective May 18, 2026, Hospira, Inc.); the NDA 17106 record on Drugs@FDA; every atropine label on DailyMed.
Highlights of the record
FDA label of May 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAtropine Sulfate Injection is indicated for temporary blockade of severe or life‑threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.
Forms and strengths
- 0.05 mg/ml
- 0.1 mg/ml
- 0.25 mg/.3ml
- 0.4 mg/ml
- 0.5 mg/.7ml
- 1 mg/ml
- 1 mg/.7ml
- 2 mg/.7ml
- 10 mg/ml
Injection (solution); injection; solution/ drops; solution.
On the market
- Earliest approval on file
- May 15, 1973 Atropen, Mmt; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first January 30, 1987; 17 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 29 of which 22 under generic applications, 11 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $7.74 per mL Atropine 1% eye drops
- Shortage (FDA)
- 6 of 19 presentations limited or unavailable updated October 5, 2026
- Recalls by its makers (FDA)
- 15 since 2012 3 Class I among all firms' recalls; latest July 24, 2026; 5 more by firms not listed as its makers
- FAERS reports
- 12,238 through July 30, 2026
What is atropine used for?
From the label: indications and usageAtropine Sulfate Injection is indicated for temporary blockade of severe or life‑threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life‑threatening muscarinic effects.
FDA pharmacologic class: Anticholinergic and Cholinergic Muscarinic Antagonist.
Source: FDA drug label (Atropine Sulfate), Hospira, Inc., effective May 18, 2026 (SPL set ad8916e7-206e-409e-2582-30d072845dd4), via openFDA; the full label on DailyMed
Is there a generic for atropine (Atropen)?
The FDA approved the first generic atropine on January 30, 1987. 18 generic applications are approved; 17 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists atropine from 22 labelers under a generic (ANDA) application and from 11 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1973 earliest approval on file
- 1987 first generic approved
- 2012 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for atropine (Atropen)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $7.74 per mL (Atropine 1% eye drops), down 15% from $9.09 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Atropine 1% eye drops (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Atropine 1% eye drop | Generic | $4.65 per mL | n/a | -30% |
| Atropine 1% eye drops | Generic | $7.74 per mL | n/a | -15% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is atropine in shortage?
The FDA Drug Shortage Database lists 6 of 19 atropine presentations as limited or unavailable (updated October 5, 2026); the first entry was posted on January 1, 2012. 11 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Atropine Sulfate, Injection, .05 mg/1 mL (NDC 16729-483-03) | Accord Healthcare Inc. | Current | October 3, 2026 |
| Atropine Sulfate, Injection, .1 mg/1 mL (NDC 16729-484-90) | Accord Healthcare Inc. | Current | October 3, 2026 |
| Atropine Sulfate, Injection, .1 mg/1 mL (NDC 76329-3340-1) | Amphastar Pharmaceuticals, Inc. | Current | October 5, 2026 |
| Atropine Sulfate, Injection, .4 mg/1 mL (NDC 0517-1004-25) | American Regent, Inc. | Current | October 1, 2026 |
| Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-512-43) | Accord Healthcare Inc. | Current | September 1, 2026 |
| Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-525-08) | Accord Healthcare Inc. | Current | September 1, 2026 |
| Atropine Sulfate, Injection, .4 mg/1 mL (NDC 63323-580-20) | Fresenius Kabi USA, LLC | Current | September 1, 2026 |
| Atropine Sulfate, Injection, .4 mg/1 mL (NDC 70069-481-10) | Somerset Therapeutics, LLC | Current | September 11, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has atropine been recalled?
The FDA's Enforcement Report lists 20 recalls naming atropine since 2012: 3 Class I (the most serious), 15 Class II, 2 Class III; 5 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of atropine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 24, 2026 | Class II | American Regent, Inc. | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde |
| December 16, 2024 | Class III | SOMERSET THERAPEUTICS LLC | Failed Impurities/Degradation Specifications |
| December 21, 2023 | Class I | Pfizer Inc. | Presence of Particulate Matter; identified as glass |
| July 3, 2023 | Class II | Accord Healthcare, Inc. | Presence of Particulate Matter: Particulate matter identified as fiber. |
| April 26, 2023 | Class II | Akorn, Inc. | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| January 30, 2023 | Class III | Akorn, Inc. | Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint. |
| June 30, 2022 | Class II | Nephron Sterile Compounding Center LLC | Lack of Assurance of Sterility |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the atropine label say about other medicines?
The atropine label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 36 other medicines name atropine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Metoclopramide | drug interactions | Injection decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia. |
| Mexiletine | drug interactions | DRUG INTERACTIONS Mexiletine: Decreases rate of mexiletine absorption. |
| Pralidoxime | drug interactions | Pralidoxime When atropine and pralidoxime are used together, the signs of atropinization (flushing, mydriasis, tachycardia, dryness of the mouth and nose) may occur earlier than might be expected when atropine is used alone because pralidoxime may potentiate the effect of atropine. |
Other labels that name atropine
- Adapalene and benzoyl peroxide and clindamycin
- Amitriptyline and perphenazine
- Benazepril and hydrochlorothiazide
- Benzoyl peroxide and clindamycin
- Clindamycin and tretinoin
- Clonidine
- Dronabinol
- Ephedrine
- Ipratropium
- Irinotecan
- Neostigmine methylsulfate
- Phenylephrine
- Pramlintide
- Propofol
- Pyridostigmine
- Remifentanil
- Siponimod
- Succinylcholine
- Sugammadex
- Thioridazine
- Tiotropium
Source: FDA drug label (Atropine Sulfate), Hospira, Inc., effective May 18, 2026 (SPL set ad8916e7-206e-409e-2582-30d072845dd4), via openFDA; the full label on DailyMed
What do FAERS reports show for atropine?
The FDA Adverse Event Reporting System holds 12,238 reports that list atropine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,405 are coded as a death and 5,287 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Atropine side effects
- the label's list beside FAERS reports
- Atropine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other