CLASS II Drug recall · Reported 29 Jun 2022 · FDA Enforcement Report
Testosterone Cypionate Injection recalled
Sun Pharmaceutical Industries is recalling Testosterone Cypionate Injection, USP, 200 mg/mL Single-dose vial per, distributed nationwide in the US. The recall was initiated on 3 Jun 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1153-2022
- FDA event ID
- 90361
- Recalling firm
- Sun Pharmaceutical Industries, Princeton, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jun 2022
- FDA classified
- 21 Jun 2022
- Reported
- 29 Jun 2022
- Type
- Voluntary: Firm initiated
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 3 Jun 2022 | Recall initiated by company | |
| 21 Jun 2022 | Classified by FDA | +18 days |
| 29 Jun 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Is Testosterone Cypionate Injection, USP, 200 mg/mL Single-dose vial per recalled?
Yes. Sun Pharmaceutical Industries recalled Testosterone Cypionate Injection, USP, 200 mg/mL Single-dose vial per on 3 Jun 2022. The recall is Class II and its status is Terminated. Recall number D-1153-2022.
Why was it recalled?
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Which lots are affected?
HAC1974A, HAC1978A, Exp 06/2023
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
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Other Testosterone Cypionate recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate Injection, 200 mg/mL, CIII recalled | Empower Clinic Services | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL recalledTestosterone Cypionate | Azurity Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, 200mg/mL, CIII recalledTestosterone Cypionate | Sun Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, 200mg/ml recalledTestosterone Cypionate | Sun Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |