The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1146-2022·Announced 2022-06-22

Medroxyprogesterone acetate injectable suspension recalled for lack of sterility assurance

Sun Pharmaceutical is recalling medroxyprogesterone acetate injectable suspension (150 mg/mL) nationwide due to lack of assurance of sterility. Affected lots contain vials with expiration dates from December 2022 through September 2023.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II recall of an injectable medication with lack of sterility assurance. While no illnesses or injuries have been reported, the hazard presents significant risk of harm—potential bacterial contamination could cause serious infections when administered to patients.

Plain-English summary

Sun Pharmaceutical Industries Inc. is recalling medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL single-dose vials (NDC 16714-981-01), manufactured for Northstart Rx LLC. Approximately 180,813 syringes have been distributed nationwide.

The recall was initiated due to lack of assurance of sterility in the affected lots. Injectable medications must maintain sterile conditions to prevent bacterial contamination, which could lead to serious infections when administered.

Affected lot numbers with expiration dates are: HAC2075A (06/2023), HAC2076A (07/2023), HAC2077A (08/2023), HAC2078A (08/2023), HAC3803A (09/2023), HAC0551A (02/2023), HAC0562A (03/2023), HAC1183A (03/2023), HAC1807A (06/2023), JKX6017A (12/2022), JKX6018A (12/2022), HAC0163A (01/2023), HAC1184A (04/2023), and HAC0162A (12/2022). Healthcare providers and patients with this medication should contact their healthcare provider and should not use affected vials.

The recalled product

Product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Northstart Rx LLC, Memphis, TN, 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC…
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Category
Drug — Injectable Contraceptive
Hazard
Affected units
180,813

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 (20)

  • Lot: HAC2075A
  • Exp 06/2023
  • HAC2076A
  • Exp 07/2023
  • HAC2077A
  • HAC2078A
  • Exp 08/2023
  • HAC3803A
  • Exp 09/2023
  • HAC0551A
  • Exp 02/2023
  • HAC0562A
  • HAC1183A
  • Exp 03/2023
  • HAC1807A
  • JKX6017A
  • JKX6018A Exp 12/2022
  • HAC0163A
  • Exp 01/2023
  • HAC1184A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by SUN PHARMACEUTICAL INDUSTRIES INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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