CLASS III Drug recall · Reported 24 Aug 2022 · FDA Enforcement Report

Azacitidine for Injection, 100 mg Lyophilized Powder recalled

Amerisource Health Services is recalling Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, distributed nationwide in the US. The recall was initiated on 27 Jul 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: FE22001A, Exp. Date 01/2024

Quantity recalled4,160 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-1349-2022
FDA event ID: 90677
Recalling firm: Amerisource Health Services, Columbus, OH
Classification: Class III
Status: Terminated
Recall initiated: 27 Jul 2022
FDA classified: 17 Aug 2022
Reported: 24 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Injectable & IV Drugs

Timeline

27 Jul 2022	Recall initiated by company
17 Aug 2022	Classified by FDA	+21 days
24 Aug 2022	Published in enforcement report	+7 days

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

Reason for recall

Subpotent Drug

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

Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56

Where it was distributed

Nationwide within the USA

Nationwide

Questions about this recall

Why was it recalled?

Subpotent Drug

Which lots are affected?

Lot #: FE22001A, Exp. Date 01/2024

Where was it sold?

Nationwide within the USA

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 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 Amerisource Health Services

All 69

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
1 Apr 2026Drug	CLASS II	Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
18 Feb 2026Drug	CLASS II	Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
5 Nov 2025Drug	CLASS II	Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride	Amerisource Health Services	Nitrosamine Impurity	Nationwide

Other Azacitidine recalls

All 9

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Drug	CLASS II	Azacitidine for Injection 100mg/Vial-Dose Vial recalled	Reliance Life Sciences Private	Sterility	Nationwide
17 Aug 2022Drug	CLASS III	Azacitidine for Injection 100mg/vial Lyophilized Powder recalledAzacitidine	Teva Pharmaceuticals USA	Potency & Assay	OH
2 Mar 2022Drug	CLASS III	Azacitidine, 100mg/vial, One Single-dose Vial recalledAzacitidine	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
2 Mar 2022Drug	CLASS III	Azacitidine, 1,00mg/Vial, One Single-dose Vial recalledAzacitidine	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
23 Dec 2020Drug	CLASS II	Azacitidine for Injection 100 mg/vial For Subcutaneous recalled by CIPLA	Cipla	Sterility	Nationwide