CLASS III Drug recall · Reported 10 Jul 2019 · FDA Enforcement Report
Testosterone Topical Solution 30mg of testosterone per pump recalled
InvaGen Pharmaceuticals is recalling Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation, distributed nationwide in the US. The recall was initiated on 12 Jun 2019 and the FDA has classified it as Class III.
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-1454-2019
- FDA event ID
- 83117
- Recalling firm
- InvaGen Pharmaceuticals, Central Islip, NY
- Brand
- Testosterone
- Manufacturer
- Cipla USA Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Jun 2019
- FDA classified
- 3 Jul 2019
- Reported
- 10 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 12 Jun 2019 | Recall initiated by company | |
| 3 Jul 2019 | Classified by FDA | +21 days |
| 10 Jul 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container; actuator may improperly function and affect dose delivery.
Product as listed by the FDA
Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Defective Container; actuator may improperly function and affect dose delivery.
Which lots are affected?
Lot GH80480 and GH80481, exp 3/2020
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from InvaGen Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS I | Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets recalledVigabatrin | InvaGen Pharmaceuticals | Packaging Defects | Nationwide |
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Other Testosterone recalls
All 91| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone, 37.5 mg, 1 Sterile Pellet recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone, 50.0 mg, 1 Sterile Pellet recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone, 18.0 mg, 1 Sterile Pellet recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |