Prefilled Syringes of Medroxyprogesterone Acetate Recalled for Lack of Sterility Assurance
Afaxys Pharma is recalling 79,339 prefilled syringes of medroxyprogesterone acetate because the manufacturer could not assure sterility. The syringes were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for an injectable pharmaceutical product where the manufacturer could not provide assurance of sterility. While no contamination has been confirmed and no illnesses have been reported, injectable medications represent a significant risk-of-harm if contaminated, warranting a High severity rating.
Plain-English summary
Sun Pharmaceutical Industries, Inc., and its US distributor Afaxys Pharma, LLC, are recalling 79,339 prefilled syringes containing medroxyprogesterone acetate injectable suspension, 150 mg/mL. The product is a prescription-only contraceptive injection with NDC 50102-591-40.
The recall was initiated because the manufacturer could not provide assurance that all syringes in the affected lots were sterile. This lack of sterility assurance means the product does not meet required safety standards for injectable medications.
The recalled syringes were distributed nationwide across the United States. The affected lot numbers are JKX4312A and JKX4313A (expiration 09/2022), JKX4827A (expiration 09/2023), and HAC1290A and HAC2082B (expiration 06/2023).
Patients who have received injections from these lots should contact their healthcare provider if they experience signs of infection, such as redness, swelling, warmth, or drainage at the injection site. Unused syringes should not be used and should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- 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
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Injectable Contraceptive
- Hazard
- sterility-failure
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lots#: JKX4312A & JKX4313A
- Exp 09/2022
- JKX4827A
- Exp 09/2023
- HAC1290A & HAC2082B
- Exp 06/2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27