Teva Recalls ParaGard T 380A Intrauterine Contraceptives for Sterility Failure
Teva Pharmaceuticals is recalling 47,890 units of ParaGard T 380A intrauterine contraceptives in New York and Kentucky due to a failed sterility test.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated Severe (4). While specific injury reports are not detailed in the text, the Class II classification for a medical device involving sterility failure meets the threshold for Severe.
Plain-English summary
Teva Pharmaceuticals USA is recalling 47,890 units of ParaGard T 380A Intrauterine Copper Contraceptive. The recall affects single units and cartons of five units with NDC 51285-204-01 and NDC 51285-204-02, expiration date 4/2015, and code 508004. The product was distributed in New York and Kentucky.
The recall was initiated because the product failed a sterility test. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have purchased or received this product should contact their healthcare provider for guidance on removal or replacement. The recalling firm is Teva Pharmaceuticals USA.
The recalled product
- Product
- ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
- Manufacturer
- Teva Pharmaceuticals USA
- Affected units
- 47,890
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 508004
- exp. 4/2015
- NDC 51285-204-01
- Single Unit 508004
- NDC 51285-204-02
- Carton of 5 Units
Distribution
Related recalls
Same manufacturer · Teva Pharmaceuticals USA
See all →- ModerateDoxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
- LowPrescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
- ModerateTretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
- LowMimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
- ModerateBrinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26
Same hazard · non sterility
See all →- SevereChloraPrep One-Step Antiseptic Solution Recall Due to Sterility Concerns
FDA (Drugs) · 2026-07-01
- SevereChloraPrep One-Step Topical Antiseptic Recalled for Non-Sterility
FDA (Drugs) · 2026-07-01
- SevereLSL Healthcare Infant Central Line Dressing Change Kit Recalled
FDA (Devices) · 2026-04-29
- HighLSL Healthcare Central Line Dressing Change Kit Recalled for Non-Sterility
FDA (Devices) · 2026-04-29
- HighLSL Healthcare Wound Closure Tray Model 7554 Recalled for Non-Sterility
FDA (Devices) · 2026-04-29