Testosterone recalls: 10 FDA reports
Recalls involving Testosterone. What was wrong with each batch, and how the FDA graded the risk.
10Reports
0Class I
4Ongoing
2025-12-10Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured
D-0198-2026 · Class III · reported 2025-12-10 · Ongoing
- Why it was recalled
- Defective Container - A defect in the side-seal which allows leakage of product.
- Product
- Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
- Where it went
- U.S. Nationwide
- How much
- 15,944 cartons
Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc.,
D-0294-2025 · Class II · reported 2025-04-02 · Ongoing
- Why it was recalled
- Presence of foreign substance: Presence of Benzene.
- Product
- Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02
- Where it went
- Nationwide in the U.S
- How much
- 244,412 Cartons; 30 sachets /Carton
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc
D-0293-2025 · Class II · reported 2025-04-02 · Ongoing
- Why it was recalled
- Presence of foreign substance: Presence of Benzene.
- Product
- Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02
- Where it went
- Nationwide in the U.S
- How much
- 195,952 Cartons; 30 sachets/Carton.
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. Nor
D-0637-2024 · Class II · reported 2024-08-28 · Ongoing
- Why it was recalled
- Superpotent Drug
- Product
- Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
- Where it went
- Product was distributed nationwide within the United States
- How much
- 7,080 unit dose packets
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pha
D-0127-2024 · Class III · reported 2023-12-06 · Terminated
- Why it was recalled
- OOS for viscosity
- Product
- Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
- Where it went
- USA nationwide
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box
D-1289-2022 · Class II · reported 2022-08-03 · Terminated
- Why it was recalled
- Superpotent Drug: Out of specification assay result was obtained during stability testing.
- Product
- Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
- Where it went
- Nationwide in the USA
- How much
- 12354 cartons
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Un
D-0100-2021 · Class III · reported 2020-11-25 · Terminated
- Why it was recalled
- Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
- Product
- Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.
- Where it went
- Product was distributed Nationwide in the USA.
- How much
- 12,088 cartons
Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solu
D-1454-2019 · Class III · reported 2019-07-10 · Terminated
- Why it was recalled
- Defective Container; actuator may improperly function and affect dose delivery.
- Product
- 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 went
- Nationwide
- How much
- 1776 bottles
Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc
D-1010-2019 · Class III · reported 2019-03-27 · Terminated
- Why it was recalled
- Defective Container: Repetitive complaints received indicating pump not working.
- Product
- 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 went
- 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.
- How much
- 3,200 bottles
Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc
D-0087-2019 · Class III · reported 2018-10-31 · Terminated
- Why it was recalled
- Defective Container: Repetitive complaints received indicating pump not working.
- Product
- 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 went
- Nationwide within the United States
- How much
- 6,752 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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