Lower riskDrug recall · FDA · Published July 22, 2022
Teva Azacitidine Injection Recall: Subpotent Drug Risk
Teva Pharmaceuticals recalls Azacitidine 100mg/vial lyophilized powder (Rx only) manufactured in Romania due to subpotent drug results from stability testing. This may affect medication effectiveness.
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
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📍Recalling firmTeva Pharmaceuticals USA Inc400 Interpace Pkwy Bldg A · Parsippany, NJ 07054-1120
✎ GovInfoNow plain-language explainer
Teva Pharmaceuticals is recalling Azac:itidine for Injection 100mg/vial lyophilized powder (Rx only) because stability testing showed the drug is less potent than expected. This could mean the medication isn't as effective as it should be for patients needing it. Read more at govinfonow.com/recall/34394-teva-azacitidine-injection-recall-subpotent-drug-risk.
“Teva Azacitidine Injection Recall: Subpotent Drug Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34394-teva-azacitidine-injection-recall-subpotent-drug-risk. Based on FDA recall #D-1334-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1334-2022%22&limit=1).
The FDA announced on July 22, 2022, that Teva Pharmaceuticals USA Inc. is recalling Azacitidine for Injection 100mg/vial Lyophilized Powder due to subpotent drug risks. The recall involves products distributed in Ohio.
How to tell if you have it
Brand: Teva Pharmaceuticals
Product: Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only
Manufacturer: Sindan Pharma SRL For BluePoint Laboratories
NDC: 68001-313-56
Lot: FE22001A
Expiration: 01/2024
Quantity: 4162 cartons
Distribution: Ohio
The hazard
The recall is due to an out-of-specification result obtained during a monitoring stability study for the Assay, with results falling below specification. This constitutes a subpotent drug hazard.
Context
GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has 59 other recalls on record since April 2, 2012. Other recent recalls of similar products include Somerset Therapeutics Cisatracurium Besylate Injection Recall (Nov. 26, 2025), Reliance Azacitidine Injection Recall (June 24, 2026), and Somerset Therapeutics Recalls Cisatracurium Injection (Nov. 26, 2025).
How to tell if you have this one
Check for the product name 'Azacitidine for Injection 100mg/vial Lyophilized Powder', Rx only, manufactured in Romania by Sindan Pharma SRL for BluePoint Laboratories. The NDC code is 68001-313-56 and lot number FE22001A (expires 01/2024).
Brand
Teva Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name, NDC code, and lot number to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed in Ohio.
Listed by the agency
Not listed
FDA distribution: “Distributed in Ohio” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall is due to potential reduced effectiveness, not immediate safety risks. It is safe to use if the medication is still within its expiration date and prescribed by a doctor.
What should I do if I have this product?
The recall does not require immediate action. Check the product details and contact your doctor if you have concerns about effectiveness.
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-1334-2022 (July 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1334-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.