Teva Recalling Over 2 Million Bottles of a Pain Reliever

Teva Pharmaceuticals USA is recalling more than 2 million bottles of 50-mg tramadol hydrochloride tablets because they contain an incorrect package insert. According to the February 26, 2020, US Food and Drug Administration (FDA) Enforcement Report, the patient leaflet contains language for 25-mg dosing that requires scored tablets, but the tablets in the bottles are unscored. 

The recall affects 50-mg tramadol hydrochloride tablets in 100-count bottles (NDC 0093-0058-01) from lots 100005876 (Exp. 2/20), 100008310 and 100008311 (Exp. 7/20), 100008638 and 100008639 (Exp. 9/20), and 100011763 (2/21).

Also included in the recall are 50-mg tramadol hydrochloride tablets in 500-count bottles (NDC 0093-0058-05) from lots: 

• 100005418, 100005419, 100005420, 100005421, 100005877, and 100005878 (Exp 1/20);  
• 100005879, 100005880, 100005881, 100005882, 100005883, 100005884, 100005885, 100005886, 100005887, 100005888, 100005889, 100005890, 100005891, 100005892, 100005893, 100005894, 100005895, 100005896, 100005897, 100005898, 100005899, 100005900, 100005901, 100005902, 100005903, 100006588, 100006718, 100006719, 100006720, and 100006721 (Exp. 2/20);  
• 100006722, 100006724, 100006725, 100006726, 100006727, 100006728, 100006729, 100006730, 100006731, 100006732, 100006733, 100006734, 100006735, 100006736, 100006737, 100006738,100007005, 100007006, 100007007, 100007008, 100007009, and 100007010 (Exp. 3/20);
• 100007011, 100007012, 100007013, 100007014, 100007015, 100007016, 100007017, 100007018, 100007019, 100007020, 100007021, 100007022, 100007023, 100007024, 100007025, 100007026, 100007027, 100007028, 100007029, 100007030, 100007031, and 100007032 (Exp. 4/20);
• 100007519, 100007520, 100007521, 100007522, 100007523, 100007524, 100007526, 100007527, 100007528, 100007529, 100007530, 100007531, 100007532, 100007533, 100007534, 100007535, 100007536, 100007537, 100007538, 100007539, 100007540, and 100007541 (Exp 5/20); 
• 100007849, 100007850, 100007852, 100007853, 100007855, 100007856, 100007858, 100007859, 100007860, 100007861, 100007862, and 100007863 (Exp. 6/20); 100008296, 100008297, 100008298, 100008299, 100008300, 100008302, and 100008303 (Exp. 7/20); 
• 100008640, 100008641, 100008643, 100008644, 100008645, 100008646, 100008647, 100008648, 100008649, 100008653, 100008654, 100008655, 100008656, 100008657, 100008658, 100008659, 100008660, 100008661, 100008662, 100008663, 100008664, 100008665, 100008666, and 100008667 (Exp. 8/20); 
• 100008668, 100008669, 100008670, 100008671, 100009232, and 100009233 (Exp. 9/20); 
• 100009999, 100010000, 100010001, 100010002, 100010003, 100010004, 100010005, 100010006, 100010007, 100010671, 100010672, 100010673, 100010674, 100010675, and 100010676 (Exp. 12/20); 
• 100010677 (Exp. 1/21); 100010805, 100010806, 100010807, 100010808, 100010809, 100010810, 100010811, 100011709, 100011710, 100011711, 100011712, 100011713, 100011714, 100011715, 100011716, and 100011896 (Exp. 2/21); 
• 100011897, 100011898, 100011899, 100011900, and 100011901 (Exp. 3/21); and 
• 100011902, 100011903, 100011904, 100011905, 100011906, 100011907, 100011908, 100011909, 100011910, 100011911, 100011912, 100011913, 100011914, and 100011918 (Exp. 4/21). 

Tablets affected by the recall were distributed throughout the United States. 

Teva Pharmaceuticals voluntarily initiated the recall January 28, 2020. The FDA designated the recall Class III on February 19, 2020. According to the classification, use of the affected product is not likely to cause adverse health consequences. 

Tramadol is a narcotic pain medication used to treat moderate to severe pain.

—Jolynn Tumolo