Tramadol Tablets (Teva) – Incorrect Package Insert (2020)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545
Brand
Teva Pharmaceuticals USA
Lot Codes / Batch Numbers
Lot#: a) 100005876, Exp 02/2020, 100008310, 100008311, Exp 07/2020, 100008638, 100008639, Exp 09/2020, 100011763, 02/2021, b) 100005418, 100005419, 100005420, 100005421, 100005877, 100005878, Exp 01/2020, 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, 100006721, Exp 02/2020, 100006722, 100006724, 100006725, 100006726, 100006727, 100006728, 100006729, 100006730, 100006731, 100006732, 100006733, 100006734, 100006735, 100006736, 100006737, 100006738, 100007005, 100007006, 100007007, 100007008, 100007009, 100007010, Exp 03/2020, 100007011, 100007012, 100007013, 100007014, 100007015, 100007016, 100007017, 100007018, 100007019, 100007020, 100007021, 100007022, 100007023, 100007024, 100007025, 100007026, 100007027, 100007028, 100007029, 100007030, 100007031, 100007032, Exp 04/2020, 100007519, 100007520, 100007521, 100007522, 100007523, 100007524, 100007526, 100007527, 100007528, 100007529, 100007530, 100007531, 100007532, 100007533, 100007534, 100007535, 100007536, 100007537, 100007538, 100007539, 100007540, 100007541, Exp 05/2020, 100007849, 100007850, 100007852, 100007853, 100007855, 100007856, 100007858, 100007859, 100007860, 100007861, 100007862, 100007863, Exp 06/2020, 100008296, 100008297, 100008298, 100008299, 100008300, 100008302, 100008303, Exp 07/2020, 100008640, 100008641, 100008643, 100008644, 100008645, 100008646, 100008647, 100008648, 100008649, 100008653, 100008654, 100008655, 100008656, 100008657, 100008658, 100008659, 100008660, 100008661, 100008662, 100008663, 100008664, 100008665, 100008666, 100008667, Exp 08/2020, 100008668, 100008669, 100008670, 100008671, 100009232, 100009233, Exp 09/2020, 100009999, 100010000, 100010001, 100010002, 100010003, 100010004, 100010005, 100010006, 100010007, 100010671, 100010672, 100010673, 100010674, 100010675, 100010676, Exp 12/2020, 100010677, Exp 01/2021, 100010805, 100010806, 100010807, 100010808, 100010809, 100010810, 100010811, 100011709, 100011710, 100011711, 100011712, 100011713, 100011714, 100011715, 100011716, 100011896, Exp 02/2021, 100011897, 100011898, 100011899, 100011900, 100011901, Exp 03/2021, 100011902, 100011903, 100011904, 100011905, 100011906, 100011907, 100011908, 100011909, 100011910, 100011911, 100011912, 100011913, 100011914, 100011918, Exp 04/2021
Products Sold
Lot#: a) 100005876, Exp 02/2020; 100008310, 100008311, Exp 07/2020; 100008638, 100008639, Exp 09/2020; 100011763, 02/2021; b) 100005418, 100005419, 100005420, 100005421, 100005877, 100005878, Exp 01/2020; 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, 100006721, Exp 02/2020; 100006722,100006724, 100006725, 100006726, 100006727, 100006728, 100006729, 100006730, 100006731, 100006732, 100006733, 100006734, 100006735, 100006736, 100006737, 100006738,100007005, 100007006, 100007007, 100007008, 100007009, 100007010, Exp 03/2020; 100007011, 100007012, 100007013, 100007014, 100007015, 100007016, 100007017, 100007018, 100007019, 100007020, 100007021, 100007022, 100007023, 100007024, 100007025, 100007026, 100007027, 100007028, 100007029, 100007030, 100007031, 100007032, Exp 04/2020; 100007519, 100007520, 100007521, 100007522, 100007523, 100007524, 100007526, 100007527, 100007528, 100007529, 100007530, 100007531, 100007532, 100007533, 100007534, 100007535, 100007536, 100007537, 100007538, 100007539, 100007540, 100007541, Exp 05/2020; 100007849, 100007850, 100007852, 100007853, 100007855, 100007856, 100007858, 100007859, 100007860, 100007861, 100007862, 100007863, Exp 06/2020; 100008296, 100008297, 100008298, 100008299, 100008300, 100008302, 100008303, Exp 07/2020; 100008640, 100008641, 100008643, 100008644, 100008645, 100008646, 100008647, 100008648, 100008649, 100008653, 100008654, 100008655, 100008656, 100008657, 100008658, 100008659, 100008660, 100008661, 100008662, 100008663, 100008664, 100008665, 100008666, 100008667, Exp 08/2020; 100008668, 100008669, 100008670, 100008671, 100009232, 100009233, Exp 09/2020; 100009999, 100010000, 100010001, 100010002, 100010003, 100010004, 100010005, 100010006, 100010007, 100010671, 100010672, 100010673, 100010674, 100010675, 100010676, Exp 12/2020; 100010677, Exp 01/2021; 100010805, 100010806, 100010807, 100010808, 100010809, 100010810, 100010811, 100011709, 100011710, 100011711, 100011712, 100011713, 100011714, 100011715, 100011716, 100011896, Exp 02/2021; 100011897, 100011898, 100011899, 100011900, 100011901, Exp 03/2021; 100011902, 100011903, 100011904, 100011905, 100011906, 100011907, 100011908, 100011909, 100011910, 100011911, 100011912, 100011913, 100011914, 100011918, Exp 04/2021
Teva Pharmaceuticals USA is recalling Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), due to Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
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 7, 2026