CLASS II Drug recall · Reported 24 Jul 2024 · FDA Enforcement Report
Cyanocobalamin Injection, USP, 1,000mcg/mL Multiple-Dose Vial recalled
Zydus Pharmaceuticals is recalling Cyanocobalamin Injection, USP, 1,000mcg/mL Multiple-Dose Vial, distributed in Tennessee. The recall was initiated on 27 Jun 2024 and the FDA has classified it as Class II.
Check your package
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-0600-2024
- FDA event ID
- 94914
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2024
- FDA classified
- 16 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Jun 2024 | Recall initiated by company | |
| 16 Jul 2024 | Classified by FDA | +19 days |
| 24 Jul 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter: glass
Product as listed by the FDA
Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.
Where it was distributed
TN
Questions about this recall
Why was it recalled?
Presence of particulate matter: glass
Which lots are affected?
Lot #: L200253, L200281, L200301, Exp 07/31/2024
Where was it sold?
TN
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zydus Pharmaceuticals
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
Other Cyanocobalamin recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin injection USP, 10,000 mcg/ (1,000 mcg/mL) recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin 2 mg/mL, Multi-Dose vial recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1,000 mcg per mL recalledCyanocobalamin | Aurobindo Pharma USA | Potency & Assay | Nationwide |