Caplin Steriles Milrinone Lactate Injection Recall: FDA Class III

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10

Lot numbers, UPCs & expiration codes

Lot #: 90000228

Where it was sold

Nationwide in Tennessee

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1144-2023
Classification: Class III
Status: Terminated
Recall initiated: Aug 14, 2023
FDA report date: Sep 13, 2023
Quantity: 19, 820 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Caplin Steriles Limited

Original FDA data

Every field from FDA enforcement report D-1144-2023, exactly as published.

Show all FDA fields

City: Gummidipoondi
Status: Terminated
Country: India
Event ID: 92900
Address: 895 & 897 Survey No
Code information: Lot #: 90000228
Report date: Sep 13, 2023
Product type: Drugs
Recall number: D-1144-2023
Classification: Class III
Recalling firm: Caplin Steriles Limited
Product quantity: 19, 820 vials
Termination date: Sep 9, 2025
Reason for recall: Failed Impurities/Degradation Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10
Distribution pattern: Nationwide in Tennessee
Recall initiation date: Aug 14, 2023
Initial firm notification: E-Mail
Center classification date: Sep 6, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1144-2023, published Sep 13, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Caplin Steriles Milrinone Lactate Injection Recall

Summary