CLASS II ONGOING Drug recall · Reported 9 Feb 2022 · FDA Enforcement Report
Medroxyprogesterone Acetate Injection, IM, 150 mg/mL recalled
Ideal Specialty Apothecary is recalling Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, distributed nationwide in the US. The recall was initiated on 21 Dec 2021 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-0463-2022
- FDA event ID
- 89270
- Recalling firm
- Ideal Specialty Apothecary, Union, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Dec 2021
- FDA classified
- 31 Jan 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Dec 2021 | Recall initiated by company | |
| 31 Jan 2022 | Classified by FDA | +41 days |
| 9 Feb 2022 | Published in enforcement report | +9 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 Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083
Where it was distributed
nationwide in the USA
Questions about this recall
Is Medroxyprogesterone Acetate Injection, IM, 150 mg/mL recalled?
Yes. Ideal Specialty Apothecary recalled Medroxyprogesterone Acetate Injection, IM, 150 mg/mL on 21 Dec 2021. The recall is Class II and its status is Ongoing. Recall number D-0463-2022.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
All lots within expiry
Where was it sold?
nationwide in 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 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 21 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 Medroxyprogesterone recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL recalledMedroxyprogesterone Acetate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | medroxyPROGESTERone Acetate Injectable Suspension recalledMedroxyprogesterone Acetate | Sun Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Medroxyprogesterone Acetate USP (Micronized) recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | medroxyPROGESTERone Acetate Tablet, 10 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Medroxyprogesterone Acetate Injection, all strengths recalled | FVS Holdings | Sterility | Nationwide |