The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0788-2020·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 lot.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is based on manufacturing deviations and similarity to a rejected lot, fitting the criteria for a moderate, precautionary recall.

Plain-English summary

Sun Pharmaceutical Industries, Inc. is recalling Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), in both 1 mL Single Use vials and 10 mL Multiple Dose Vials. The product is distributed throughout the United States and is available by prescription only.

The recall was initiated because of current Good Manufacturing Practice (cGMP) deviations. The released lots were manufactured under similar conditions to a previously rejected Out-of-Specification (OOS) lot. Specific lot numbers and expiration dates are listed in the recall documentation.

Healthcare providers and patients should discontinue use of the affected lots and contact Sun Pharmaceutical Industries for further instructions or a replacement.

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 (20)

  • a) JKT0075A
  • JKT0076A
  • JKT0213A
  • JKT0215A
  • JKT0369A
  • JKT0214A
  • JKT0368A
  • JKT0370A exp Jan-20
  • JKT0371A
  • JKT0515A
  • JKT0514A
  • JKT0516A
  • JKT0518A
  • JKT0517A
  • JKT0694A
  • JKT0695A
  • JKT0696A
  • exp Feb-20
  • JKT0697A
  • JKT0698A

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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