CLASS III Drug recall · Reported 27 Mar 2019 · FDA Enforcement Report
Testosterone Topical Solution, 30mg recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Testosterone Topical Solution, 30mg, distributed nationwide in the US. The recall was initiated on 13 Mar 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-1010-2019
- FDA event ID
- 82392
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Testosterone
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Mar 2019
- FDA classified
- 19 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 13 Mar 2019 | Recall initiated by company | |
| 19 Mar 2019 | Classified by FDA | +6 days |
| 27 Mar 2019 | 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
Defective Container: Repetitive complaints received indicating pump not working.
Product as listed by the FDA
Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11
Where it was distributed
Recalled product was distributed to 7 major wholesale/drug chain distributors and 1 supermarket chain that may have further distribute the product throughout the United States.
Questions about this recall
Why was it recalled?
Defective Container: Repetitive complaints received indicating pump not working.
Which lots are affected?
Lot # K700086, Exp 11/2019
Where was it sold?
Recalled product was distributed to 7 major wholesale/drug chain distributors and 1 supermarket chain that may have further distribute the product throughout the United States.
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.
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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 |