CLASS II Drug recall · Reported 22 Jun 2022 · FDA Enforcement Report

medroxyPROGESTERone Acetate Injectable Suspension recalled

SUN Pharmaceutical Industries is recalling medroxyPROGESTERone Acetate Injectable Suspension, USP Prefilled Syringe, 150 mg/mL, distributed nationwide in the US. The recall was initiated on 6 May 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots#: JKX4312A & JKX4313A, Exp 09/2022; JKX4827A, Exp 09/2023; HAC1290A & HAC2082B, Exp 06/2023;

Quantity recalled79339 syringes

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-1143-2022
FDA event ID: 90151
Recalling firm: SUN Pharmaceutical Industries, Princeton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 6 May 2022
FDA classified: 10 Jun 2022
Reported: 22 Jun 2022
Type: Voluntary: Firm initiated
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

6 May 2022	Recall initiated by company
10 Jun 2022	Classified by FDA	+35 days
22 Jun 2022	Published in enforcement report	+12 days

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

Reason for recall

Lack of assurance of sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of Italy, NDC 50102-591-40.

Where it was distributed

USA Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Lack of assurance of sterility

Which lots are affected?

Lots#: JKX4312A & JKX4313A, Exp 09/2022; JKX4827A, Exp 09/2023; HAC1290A & HAC2082B, Exp 06/2023;

Where was it sold?

USA Nationwide

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.

Other products in this recall event

4 other products · FDA event 90151

This product is part of a recall event; the main page for the event is medroxyPROGESTERone Acetate Injectable Suspension recalled.

Reported	Class	Recall	Company	Reason	Where
22 Jun 2022	CLASS II	medroxyPROGESTERone Acetate Injectable Suspension recalled	SUN Pharmaceutical Industries	Sterility	Nationwide
22 Jun 2022	CLASS II	medroxyPROGESTERone Acetate Injectable Suspension recalled	SUN Pharmaceutical Industries	Sterility	Nationwide
22 Jun 2022	CLASS II	medroxyPROGESTERone Acetate Injectable Suspension recalledMedroxyprogesterone Acetate	SUN Pharmaceutical Industries	Sterility	Nationwide
22 Jun 2022	CLASS II	medroxyPROGESTERone Acetate Injectable Suspension recalled	SUN Pharmaceutical Industries	Sterility	Nationwide

More recalls from SUN Pharmaceutical Industries

All 138

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Carbamazepine Tablets, USP, 200mg recalled	SUN Pharmaceutical Industries	Manufacturing (CGMP) Deviations	Nationwide
8 Jul 2026Drug	CLASS III	Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
1 Jul 2026Drug	CLASS II	Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel	SUN Pharmaceutical Industries	Packaging Defects	Nationwide
17 Jun 2026Drug	CLASS I	DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride	SUN Pharmaceutical Industries	Particulate Matter	Nationwide
17 Jun 2026Drug	CLASS II	Budesonide Inhalation Suspension, 1mg recalledBudesonide	SUN Pharmaceutical Industries	Particulate Matter	Nationwide

Other Medroxyprogesterone recalls

All 24

Reported	Class	Recall	Company	Reason	Where
7 May 2025Drug	CLASS II	Medroxyprogesterone Acetate Injectable Suspension recalled	Mckesson Medical-Surgical Inc. Corporate Office	Potency & Assay	FL, MS
15 Jan 2025Drug	CLASS II	medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL recalledMedroxyprogesterone Acetate	Eugia US	Manufacturing (CGMP) Deviations	Nationwide
9 Nov 2022Drug	CLASS II	Medroxyprogesterone Acetate 300 MG/ML Suspension vial recalled	Pharmacy Plus	Sterility	4 states
22 Jun 2022Drug	CLASS II	medroxyPROGESTERone Acetate Injectable Suspension recalled	SUN Pharmaceutical Industries	Sterility	Nationwide
22 Jun 2022Drug	CLASS II	medroxyPROGESTERone Acetate Injectable Suspension recalledMedroxyprogesterone Acetate	SUN Pharmaceutical Industries	Sterility	Nationwide