Food, drugs, devices › Sun Pharmaceutical Industries, Inc.
Drug recall: Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx o
Sun Pharmaceutical Industries, Inc. (Cranbury, NJ) initiated this drug recall on 14 Jan 2020; FDA lists 2 product records under event 84672, classified Class II.
FDA defines Class II as 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. 64% of the 342 drug enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 31 Aug 2020. Initiation: voluntary: firm initiated. Sun Pharmaceutical Industries, Inc. has 94 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ.
Reason for recall
"cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot."
Distribution
"Product was distributed throughout the United States."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0787-2020 | Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India | — | Class II | Terminated | 22 Jan 2020 |
| D-0788-2020 | Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India | — | Class II | Terminated | 22 Jan 2020 |
Context
Other enforcement events for Sun Pharmaceutical Industries, Inc.
All 94 events for Sun Pharmaceutical Industries, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed throughout the United States."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.