Dr. Reddy's Laboratories Zoledronic Acid Injection Recall

Why it was recalled

Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial

Product description

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52

Lot numbers, UPCs & expiration codes

Lot BS523, exp 10/2017

Where it was sold

Nationwide

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-0784-2016
Classification: Class II
Status: Terminated
Recall initiated: Mar 3, 2016
FDA report date: Apr 6, 2016
Quantity: 3,342 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Dr. Reddy's Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0784-2016, exactly as published.

Show all FDA fields

City: Princeton
State: NJ
Status: Terminated
Country: United States
Event ID: 73527
Address: 107 College Rd E
Code information: Lot BS523, exp 10/2017
Postal code: 08540-6623
Report date: Apr 6, 2016
Product type: Drugs
Recall number: D-0784-2016
Classification: Class II
Recalling firm: Dr. Reddy's Laboratories, Inc.
Product quantity: 3,342 vials
Termination date: May 3, 2017
Reason for recall: Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Voluntary / mandated: Voluntary: Firm initiated
Product description: Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52
Distribution pattern: Nationwide
Recall initiation date: Mar 3, 2016
Initial firm notification: Letter
Center classification date: Mar 28, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0784-2016, published Apr 6, 2016. View the source record (openFDA) · FDA enforcement reports

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

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