Manufacturer profile
Boiron
Pharmaceutical company6 products tracked
6
products tracked
85,055
total reports
12
recalls on record
81.3%
serious overall
Products
showing 6 of 6
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 1946 | 48,897 | Chronic kidney disease | 10 | |
| — | 22,469 | Immunodeficiency | 0 | |
| 2005 | 8,945 | Drug abuse | 2 | |
| — | 4,170 | Product substitution issue | 0 | |
| — | 572 | Vaginal flatulence | 0 | |
| — | 2 | — | 0 |
Recall history · 12 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Feb 17, 2025 | II | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC |
| Apr 26, 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| Mar 15, 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| May 31, 2019 | II | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC |
| May 31, 2019 | II | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC |
| May 7, 2018 | II | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC |
| Apr 10, 2018 | III | Presence of Foreign Tablets/Capsules | Aidarex Pharmaceuticals LLC |
| Mar 25, 2016 | II | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy |
| Nov 14, 2014 | II | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. | Attix Pharmaceuticals |
| Jul 2, 2013 | II | Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) may be potentially mislabeled as RAMIPRIL, Capsule, 2.5 mg, NDC 68180058901, Pedigree: AD54549_16, EXP: 5/20/2014. | Aidapak Services, LLC |
| Jul 2, 2013 | II | Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W002711, EXP: 6/6/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W002825, EXP: 12/31/2013; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60236_1, EXP: 5/22/2014. | Aidapak Services, LLC |
| Dec 28, 2012 | I | Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness) | Advance Pharmaceutical Inc |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Boiron are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.