Recent FDA Drug Recalls - December 2025: Duloxetine Recall, Bisoprolol Fumarate, Testosterone Gel

(December 11, 2025)

Quick Links: Duloxetine;  Bisoprolol; Testosterone Gel;

Drug Recall: Duloxetine delayed release capsules (Cymbalta generic) by Towa

Breckenridge Pharmaceutical is recalling 10,786 bottles of antidepressant Duloxetine Delayed-Release Capsules, 60 mg strength (90-count and 1,000-count), manufactured by Towa Pharmaceutical Europe, Barcelona, Spain. Two lots affected by the recall was manufactured by Towa for Quallient Pharmaceuticals Health. The recall was due to nitrosamine impurities above FDA limits, a potential cancer risk. Refer to the FDA recall announcement for specific lot numbers and expiration dates. Breckenridge has had other recent recalls for the antidepressant duloxetine. Read August recall report and November.
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Drug Recall:  Bisoprolol Fumarate and Hydrochlorothiazide Tablets (Ziac generic) by Glenmark

Glenmark Pharma is recalling 11,306 bottles of Bisoprolol Fumarate and Hydrochlorothiazide tablets, 2.5 mg/6.25 mg strength, 30, 100, and 500-count bottles. Manufactured in Pithampur, Madhya Pradesh, the recall is due to cross contamination. Testing of reserve samples showed presence of traces of ezetimibe (a cholesterol drug with the brand name Zetia). The recalled tablets are used for treating high blood pressure and are a "beta blocker" type of medication. This is a class III recall, the least serious type of recall. See FDA recall announcement for affected lots and dates.
Recall Announcement

Read or add patient experience with Bisoprolol Fumarate and Hydrochlorothiazide Tablets or Ziac

 

Drug Recall: Testosterone Gel by Actavis (Teva)

Teva Pharmaceuticals is recalling 15,944 cartons of Testosterone Gel 1%, 2.5 grams per unit dose (30 packets per carton) due to a defect in the side seal of the packets. This defect could cause leakage of the gel product. This is a class III recall, the least serious type of recall and is at the retail level. The product was manufactured by Actavis Labs in Salt Lake City, Utah. Check the recall announcement for detailed lot and expiration information.
Recall Announcement

 

Note: Recall information is from FDA Enforcement Reports, which are linked. Check the announcements for specific lot numbers and expiration dates. The recalls on this page are classified as Class II of III . The recalls are also directed at the supplier level, not the consumer, but consumers may want to check the announcements to make sure they do not have product that was distributed prior to the recall announcement.