Quick answers
- What is Atropine used for?
- The FDA-approved label (ATROPEN Auto-Injector, Meridian Medical Technologies LLC, September 15, 2022) says: “ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Atropine have a boxed warning?
- No. None of the 53 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Atropine?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 27, 2026). Ask your pharmacist about alternatives.
- Has Atropine been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started July 24, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Atropine?
- 27 companies list prescription products of Atropine in the FDA NDC Directory, including Medical Purchasing Solutions, LLC, Somerset Therapeutics, LLC and HF Acquisition Co LLC, DBA HealthFirst.
What Atropine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients. …
— FDA label: ATROPEN Auto-Injector, Meridian Medical Technologies LLC, effective September 15, 2022. Read the full label on DailyMed →
The FDA has 53 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 53 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection · Solution/ drops · Solution |
|---|---|
| Route | Intravenous · Ophthalmic · Intramuscular · Endotracheal · Subcutaneous · Intramedullary |
| Prescription products | 75 in the FDA NDC Directory |
| Brand names | Atropen Auto-Injector, Isopto Atropine |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| atropine sulfate 10 mg/mL solution | Generic | $9.72–$19.64 per mL 2 packages, lowest to highest |
| atropine sulfate 10 mg/mL solution/ drops | Generic | $4.26–$10.50 per mL 18 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Medical Purchasing Solutions, LLC8 products
- Somerset Therapeutics, LLC7 products
- HF Acquisition Co LLC, DBA HealthFirst5 products
- ProPharma Distribution5 products
- Meridian Medical Technologies LLC5 products
- Henry Schein, Inc.4 products
- Accord Healthcare Inc.4 products
- Hikma Pharmaceuticals USA Inc.3 products
- Lifestar Pharma LLC3 products
- A-S Medication Solutions3 products
- Amneal Pharmaceuticals NY LLC3 products
- Remedyrepack Inc.3 products
- Gland Pharma Limited3 products
- Alcon Laboratories, Inc.2 products
- American Regent, Inc.2 products
- Redpharm Drug2 products
- Amneal Pharmaceuticals LLC2 products
- Hospira, Inc.2 products
- NorthStar RxLLC1 product
- Edenbridge Pharmaceuticals LLC.1 product
- Fresenius Kabi USA, LLC1 product
- Medefil, Inc.1 product
- Bausch & Lomb Americas Inc.1 product
- International Medication Systems, Limited1 product
- Bausch & Lomb Incorporated1 product
- Apotex Corp.1 product
- Rafa Laboratories, Ltd.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017106 ATROPEN | Mmt | May 15, 1973 | 32, latest November 20, 2020 2020: Labeling · 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
| NDA021146 ATROPINE SULFATE | Hospira | July 9, 2001 | 8, latest July 30, 2025 2025: Labeling · 2020: Manufacturing (CMC) · 2020: Labeling |
| NDA208151 ISOPTO ATROPINE | Alcon Labs Inc | December 1, 2016 | 1, latest August 12, 2022 2022: Manufacturing (CMC) |
| NDA209260 ATROPINE SULFATE | Fresenius Kabi USA | January 26, 2018 | — |
| NDA212319 ATROPINE (AUTOINJECTOR) | Rafa Labs Ltd | July 9, 2018 | 2, latest February 27, 2023 2023: Labeling · 2019: Labeling |
| NDA213581 ATROPINE SULFATE | Bausch and Lomb Inc | March 15, 2022 | — |
| NDA214652 ATROPINE SULFATE | Accord Hlthcare | September 29, 2020 | 2, latest February 4, 2026 2026: Labeling · 2025: Labeling |
Generic approvals (17)
- ANDA212461Intl Medication Sys · October 5, 2020
- ANDA213424Accord Hlthcare · March 19, 2021
- ANDA212868Accord Hlthcare · July 26, 2021
- ANDA215624Apotex · November 26, 2021
- ANDA213561Hikma · December 1, 2021
- ANDA215342Amneal · January 26, 2022
- ANDA216120Am Regent · May 26, 2022
- ANDA214752Amneal · July 14, 2022
- ANDA214970Medefil Inc · November 4, 2022
- ANDA218148Mankind Pharma · January 8, 2024
- ANDA217791Somerset · April 29, 2024
- ANDA215618Somerset Theraps LLC · July 1, 2024
- ANDA215969Somerset Theraps LLC · July 3, 2024
- ANDA215005Somerset Theraps LLC · November 29, 2024
- ANDA217345Hikma · October 24, 2025
- ANDA219013Edenbridge Pharms · April 15, 2026
- ANDA219996Gland · July 31, 2026
Shortage status
Current shortage · updated October 27, 2026 · first posted January 1, 2012
| Product | Atropine Sulfate, Injection, 1 mg/1 mL (NDC 70069-641-25) |
|---|---|
| Availability | Available |
| Company | Somerset Therapeutics, LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 24, 2026 · Class II · Ongoing · D-0795-2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, — American Regent, Inc.
-
December 16, 2024 · Class III · Terminated · D-0169-2025
Failed Impurities/Degradation Specifications
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01 — SOMERSET THERAPEUTICS LLC
-
December 21, 2023 · Class I · Ongoing · D-0235-2024
Presence of Particulate Matter; identified as glass
Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (ca — Pfizer Inc.
-
July 3, 2023 · Class II · Terminated · D-0917-2023
Presence of Particulate Matter: Particulate matter identified as fiber.
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 — Accord Healthcare, Inc.
-
April 13, 2022 · Class II · Terminated · D-1035-2022
cGMP deviations: Temperature abuse
Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55 — Mckesson Medical-Surgical Inc. Corporate Office
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1190536, 1190538, 1190540, 1190542, 1190546, 1190551, 1190552, 1190608, 1190611, 1190614 … (+6) |
|---|---|
| SPL set ID of the quoted label | e2d4307d-da8f-49f5-aac0-02355dd9ffb7 |
| FDA labels (SPL) | 53 |
| FDA applications | NDA017106, NDA021146, NDA208151, NDA209260, NDA212319, NDA213581, NDA214652, 17 ANDA |
| Active ingredients (FDA) | ATROPINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — ATROPEN Auto-Injector, Meridian Medical Technologies LLC, effective September 15, 2022; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →