Use caution Drug recall · FDA · Published April 5, 2022

Aurobindo Recalls Cyanocobalamin Injection Due to Subpotency

Aurobindo Pharma recalls Cyanocobalamin Injection vials due to subpotent drug issues. Check lot numbers CCC210004 through CCC210011 for expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0766-2022Drug Aurobindo Pharma ›

Use caution until it’s fixed

Subpotent Drug: Out of Specification results for Assay

Take action

Contact the company

Recalling firmAurobindo Pharma USA Inc.279 Princeton Hightstown Rd · East Windsor, NJ 08520-1401

✎ GovInfoNow plain-language explainer

Aurobindo Pharma USA Inc. is recalling Cyanocobalamin Injection, USP (Vitamin B12) because some vials are subpotent and do not meet assay specifications. The recall affects 433,809 vials distributed nationwide in the USA. This means patients may receive less medication than labeled. Read more at govinfonow.com/recall/34983-aurobindo-recalls-cyanocobalamin-injection-due-to-subpotency.

Source Summary by GovInfoNow · govinfonow.com/recall/34983-aurobindo-recalls-cyanocobalamin-injection-due-to-subpotency · Updated October 10, 2026 · FDA enforcement record: FDA #D-0766-2022

Cite this page

“Aurobindo Recalls Cyanocobalamin Injection Due to Subpotency.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/34983-aurobindo-recalls-cyanocobalamin-injection-due-to-subpotency. Based on FDA recall #D-0766-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0766-2022%22&limit=1).

The FDA announced on April 5, 2022, that Aurobindo Pharma USA Inc. is recalling Cyanocobalamin Injection, USP due to subpotent drug risks from out-of-specification assay results. The firm initiated this voluntary Class III recall affecting 433,809 vials distributed nationwide.

How to tell if you have it

Brand: Aurobindo Pharma
Product: Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC
NDC: 55150-364-01
Lots: CCC210004 (Exp 09/2022); CCC210005, CCC210006, CCC210007 (Exp 11/2022); CCC210010, CCC210011 (Exp 04/2023)

The hazard

The recall addresses subpotent drug risks caused by out-of-specification results for the assay. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Aurobindo Pharma USA Inc has 32 other recalls on record since April 9, 2013. Other recent recalls of similar products include Aurobindo Pharma recalls 10mg Dicyclomine Capsules due to empty capsules (July 23, 2026), Aurobindo Pharma Acetaminophen Tablets Recall: Brown Tablet Discoloration Risk (May 22, 2025), and Aurobindo Nebivolol Tablets Recall: Nitrosamine Impurity Risk (Dec. 6, 2024). Other recent recalls of similar products include American Regent Cyanocobalamin Injection Recall: Particulate Matter Hazard (July 24, 2026), Somerset Therapeutics Cisatracurium Besylate Injection Recall: Subpotent Product Risk (Nov. 26, 2025), and Gasco Isopropyl Alcohol 70% Recall: Subpotent Drug Risk (May 29, 2026).

How to tell if you have this one

Look for Cyanocobalamin Injection, USP, 1,000 mcg per mL, 1 mL Vial, Rx Only, manufactured in India for Auromedics Pharma LLC. Check the NDC 55150-364-01 and lot numbers CCC210004 (Exp 09/2022), CCC210005, CCC210006, CCC210007 (Exp 11/2022), and CCC210010, CCC210011 (Exp 04/2023).

Brand
Aurobindo Pharma
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Verify if your vial matches the recalled NDC and lot numbers listed in the record.
Contact Healthcare Provider
Speak with your doctor or pharmacist about replacing the medication if you have a recalled lot.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Apr 5, 2022Firm started the recall
Apr 12, 2022FDA classified it Class III
Apr 20, 2022Published in FDA’s Enforcement Report
Jun 27, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What are the expiration dates?

CCC210004 expires 09/2022; CCC210005-CCC210007 expire 11/2022; CCC210010-CCC210011 expire 04/2023.

Similar recalls

Other Aurobindo Pharma recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/34983-aurobindo-recalls-cyanocobalamin-injection-due-to-subpotency">Aurobindo Recalls Cyanocobalamin Injection Due to Subpotency (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0766-2022 (April 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0766-2022 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.