Harmony Brands Llc B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits).
Brand
Harmony Brands Llc
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Harmony Brands Llc is recalling B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items due to Lack of assurance of safety and efficacy; products are from unknown sources.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance of safety and efficacy; products are from unknown sources.
Recommended Action
Per FDA guidance
Harmony issued a press release on 3/25/05. Consignees to the retail level were notified by letter beginning on 3/28/05.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026