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Atropine Sulfate Injection shortage

Current  19 presentations · 8 manufacturers · first FDA posting 2012-01-01 · last update 2026-10-15

Manufacturers: Accord Healthcare Inc., American Regent, Inc., Amphastar Pharmaceuticals, Inc., Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA, Inc., Hospira, Inc., a Pfizer Company, Medefil, Inc., Somerset Therapeutics, LLC

Stated reasons (per FDA): Discontinuation of the manufacture of the drug; Other; Requirements related to complying with good manufacturing practices

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Presentations

PresentationManufacturerStatusReasonNotes (FDA)Dates
Atropine Sulfate, Injection, .05 mg/1 mL (NDC 16729-483-03)Accord Healthcare Inc.Current
Unavailable
Discontinuation of the manufacture of the drugDiscontinuation of the manufacture of the drugPosted 01/01/2020
Updated 10/03/2026
Atropine Sulfate, Injection, 0.1 mg/1 mL (NDC 16729-484-45)Accord Healthcare Inc.Current
Available
—Posted 01/01/2020
Updated 10/03/2026
Atropine Sulfate, Injection, .1 mg/1 mL (NDC 16729-484-90)Accord Healthcare Inc.Current
Unavailable
Discontinuation of the manufacture of the drugDiscontinuation of the manufacture of the drugPosted 01/01/2020
Updated 10/03/2026
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-512-43)Accord Healthcare Inc.Current
Unavailable
Requirements related to complying with good manufacturing practicesEstimated recovery: TBDPosted 01/01/2012
Updated 10/03/2026
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-525-08)Accord Healthcare Inc.Current
Unavailable
Requirements related to complying with good manufacturing practicesEstimated recovery: mid-September 2026Posted 01/01/2012
Updated 09/01/2026
Atropine Sulfate, Injection, 1 mg/1 mL (NDC 16729-526-08)Accord Healthcare Inc.Current
Unavailable
Requirements related to complying with good manufacturing practicesEstimated recovery: late December 2026/early January 2027Posted 01/01/2012
Updated 10/03/2026
Atropine Sulfate, Injection, 1 mg/1 mL (NDC 0517-1001-25)American Regent, Inc.Current
Available
—Posted 01/01/2012
Updated 10/15/2026
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 0517-1004-25)American Regent, Inc.Current
Available
—Posted 01/01/2012
Updated 10/15/2026
Atropine Sulfate, Injection, .1 mg/1 mL (NDC 76329-3340-1)Amphastar Pharmaceuticals, Inc.Current
Available
—Posted 01/01/2020
Updated 10/05/2026
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 63323-580-20)Fresenius Kabi USA, LLCCurrent
Unavailable
OtherNext release October 2026. Check wholesalers for inventory.Posted 01/01/2012
Updated 10/15/2026
Atropine Sulfate, Injection, 0.4 mg/1 mL (NDC 0641-6251-10)Hikma Pharmaceuticals USA, Inc.Current
Available
—Posted 12/20/2023
Updated 10/14/2026
Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) Syringes (NDC 0409-1630-10)Hospira, Inc., a Pfizer CompanyCurrent
Unavailable
OtherNext Delivery and Estimated Recovery: December 2026. Shortage per Manufacturer: Manufacturing DelayPosted 01/01/2012
Updated 10/08/2026
Atropine Sulfate, Injection, 0.25 mg/5 mL (0.05 mg/mL) Syringes (NDC 0409-9630-05)Hospira, Inc., a Pfizer CompanyCurrent
Available
—Posted 01/01/2012
Updated 10/08/2026
Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) Syringes (NDC 64253-400-91)Medefil, Inc.Current
Available
—Posted 01/01/2012
Updated 10/15/2026
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 70069-481-10)Somerset Therapeutics, LLCCurrent
Available
—Posted 01/01/2012
Updated 09/11/2026
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 70069-631-25)Somerset Therapeutics, LLCCurrent
Available
—Posted 01/01/2012
Updated 09/11/2026
Atropine Sulfate, Injection, 1 mg/1 mL (NDC 70069-641-25)Somerset Therapeutics, LLCCurrent
Available
—Posted 01/01/2012
Updated 09/11/2026
Atropine Sulfate, Injection, (Adult) 0.5 mg/5 mL (0.1 mg/mL) LifeShield® ABBOJECT® Glass Syringe (20 G x 1 1/2) (NDC 0409-4910-34)"Hospira, Inc., a Pfizer CompanyTo Be Discontinued
—Discontinuation of the manufacture of the drugPosted 11/07/2025
Updated 11/07/2025
Discontinued 11/07/2025
Atropine Sulfate, Injection, (Adult)1 mg/10 mL (0.1 mg/mL) LifeShield® ABBOJECT® Glass Syringe (20 G x 1 1/2) (NDC 0409-4911-34)"Hospira, Inc., a Pfizer CompanyTo Be Discontinued
—Discontinuation of the manufacture of the drugPosted 11/07/2025
Updated 11/07/2025
Discontinued 11/07/2025

Source: FDA Drug Shortages Database · raw openFDA records

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