CLASS III Drug recall · Reported 3 Oct 2018 · FDA Enforcement Report

Zoledronic Acid Injection, 5mg/ (0.05 mg/mL) vial recalled

Dr. Reddy's Laboratories is recalling Zoledronic Acid Injection, 5mg/ (0.05 mg/mL) vial, distributed nationwide in the US. The recall was initiated on 12 Sep 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesBatch Numbers: BS633, EXP 9/2018; BS701, BS702, BS703, EXP 12/2018; BS708, BS709, BS711, BS712, BS713, BS714, BS715, EXP 3/2019; BS726, BS727, EXP 6/2019; BS728, BS729, BS730, EXP 7/2019; BS801, EXP 03/2020..

Quantity recalled59,468 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0103-2019
FDA event ID: 81012
Recalling firm: Dr. Reddy's Laboratories, Princeton, NJ
Classification: Class III
Status: Terminated
Recall initiated: 12 Sep 2018
FDA classified: 26 Oct 2018
Reported: 3 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Injectable & IV Drugs

Timeline

12 Sep 2018	Recall initiated by company
3 Oct 2018	Published in enforcement report	+21 days
26 Oct 2018	Classified by FDA	+23 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities/Degradation Specifications: OOS for unknown impurities.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52

Where it was distributed

Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.

Nationwide

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications: OOS for unknown impurities.

Which lots are affected?

Batch Numbers: BS633, EXP 9/2018; BS701, BS702, BS703, EXP 12/2018; BS708, BS709, BS711, BS712, BS713, BS714, BS715, EXP 3/2019; BS726, BS727, EXP 6/2019; BS728, BS729, BS730, EXP 7/2019; BS801, EXP 03/2020..

Where was it sold?

Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 81012

This product is part of a recall event; the main page for the event is Zoledronic Acid Injection, 5 mg/ (0.05 mg/mL) One Single-Dose recalled.

Reported	Class	Recall	Company	Reason	Where
3 Oct 2018	CLASS III	Zoledronic Acid Injection, 5 mg/ (0.05 mg/mL) One Single-Dose recalledZoledronic Acid	Dr. Reddy's Laboratories	Potency & Assay	Nationwide

More recalls from Dr. Reddy's Laboratories

All 165

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025Drug	CLASS III	Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
15 Oct 2025Drug	CLASS II	Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
23 Jul 2025Drug	CLASS II	Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole	Dr. Reddy's Laboratories	Other	Nationwide
23 Apr 2025Drug	CLASS I	Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam	Dr. Reddy's Laboratories	Labeling Errors	Nationwide
18 Dec 2024Drug	CLASS III	Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor	Dr. Reddy's Laboratories	Potency & Assay	Nationwide

Other Zoledronic Acid recalls

All 5

Reported	Class	Recall	Company	Reason	Where
5 Jun 2024Drug	CLASS II	Zoledronic Acid Injection 5mg/ Sterile Solution Single-Dose vials recalled	Dr. Reddy's Laboratories	Sterility	Nationwide
4 Mar 2020Drug	CLASS III	Zoledronic Acid Injection 5 mg/ (0.05 mg/mL), Solution recalled	Breckenridge Pharmaceutical	Potency & Assay	Nationwide
3 Oct 2018Drug	CLASS III	Zoledronic Acid Injection, 5 mg/ (0.05 mg/mL) One Single-Dose recalledZoledronic Acid	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
6 Apr 2016Drug	CLASS II	Zoledronic Acid Injection, 5 mg/ (0.05 mg/mL) Single Use recalled	Dr. Reddy's Laboratories	Foreign Material	Nationwide