The Recall Desk
SevereFDA (Drugs)·D-0787-2020·Announced 2020-01-22

Sun Pharmaceutical Recalls Testosterone Cypionate Injection Due to cGMP Deviations

Sun Pharmaceutical Industries is recalling Testosterone Cypionate for Injection due to cGMP deviations and similarity to a previously rejected out-of-specification lot.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), as the agency's own classification mandates a minimum score of 4.

Plain-English summary

Sun Pharmaceutical Industries, Inc. is recalling Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial. The product is distributed throughout the United States and is available under NDC 62756-017-40, among others.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations. The released lots were manufactured under similar manufacturing conditions to a previously rejected out-of-specification (OOS) lot. Specific lot numbers and expiration dates are listed in the official recall notice.

Healthcare providers and patients should stop using the affected lots and contact Sun Pharmaceutical Industries for further instructions. The FDA classifies this recall as Class II, indicating a reasonable probability that temporary or medically reversible adverse health consequences may occur.

The recalled product

Product
TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
Brand
TESTOSTERONE CYPIONATE
Manufacturer
Sun Pharmaceutical Industries, Inc.
Category
Drug — Prescription Injection
Hazard

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 (16)

  • JKT0933A
  • JKT0935A
  • JKT1062A exp Mar-20
  • JKT1425A
  • JKT1483A exp Apr-20
  • JKT1575A
  • JKT1729A
  • JKT1730A
  • JKT1728A exp May-20 JKT2002A exp Jun-20
  • JKT3216A
  • JKT3217A exp Sep-20
  • JKT3589A
  • JKT3590A
  • JKT3626A exp Oct-20
  • JKT3864A
  • JKT3935A exp Dec-20

UPCs (3)

  • 0362756017405
  • 0362756015401
  • 0362756016408

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same brand · TESTOSTERONE CYPIONATE

Same manufacturer · Sun Pharmaceutical Industries, Inc.

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Same hazard · cGMP deviation

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