Novartis Consumer Health issued a sweeping recall of four over-the-counter (OTC) drugs that could have chipped or broken pills or contain incorrect medications.

Excedrin, Bufferin, Gas-X Prevention and NoDoz are all affected by the recall. See the complete list below.

Endo Pharmaceuticals, along with the U.S. Food and Drug Administration (FDA), simultaneously issued a pharmaceutical level advisory about opioid products, specifically Opana ER, that could also contain mismatched pills.

Opioids like Opana are typically used as strong, prescribed pain-killers.

Edward Cox, director of antimicrobial products for the FDA, said there is an ongoing investigation into Novartis and its Lincoln, Neb., factory that manufactured all affected drugs.

Novartis is aware of three consumer mixups since 2009 but has no reports of any adverse effects. This recall won’t come cheaply for Novartis, though, which “will take a one-time charge currently estimated at USD 120 million in the fourth quarter of 2011, relating to the recalls and improvement work at the Lincoln, NE facility,” said the company’s statement. Novartis could also lose about $560 million in sales because of the recalls.

Novartis temporarily stopped production at, and shipments leaving from, its  Lincoln plant on Dec. 19 to accelerate “maintenance, process upgrades and improvements, and training to continue strengthening standards at the site,” said a statement provided by Julie Masow, director of external communications for Novartis.

Cox said no recall of the Endo opioid products is necessary because it is a “medically necessary product” and the “likelihood is low” that there was a mixup at the pharmaceutical level.

The FDA tells consumers to check bottles of any affected Novartis products for pills of a different size, shape and color. Anyone who has an affected product should stop taking the medicine and contact Novartis for information on returning their product. Those with Opana products should return them to their pharmacy.

Cox said the FDA is not aware of any Opana products entering the OTC market, or vice-versa, but it is a possibility and is still under investigation.

The Novartis recall and Endo Pharmaceuticals advisory come after a December plant inspection that raised issues and concerns for the FDA.

In 2005, Novartis recalled lots of GenTeal eye lubricant. In June last year, Endo Pharmaceuticals recalled Endocet for having mismatched dosages in the same bottle.

Affected products are listed below. Thanks eFoodAlert for the expanded list.

• Bufferin® Extra Strength Tablets 130CT: UPC 300672065131
• Bufferin® Extra Strength Tablets 39CT: UPC 300672065391
• Bufferin® Low Dose Tablets 130CT: UPC 300676424132
• Bufferin® Regular Strength Tablets 130CT: UPC 300672063137
• Excedrin® Back & Body Caplets 100CT Account Specific: UPC
• 300676238920
• Excedrin® Back & Body Caplets 100CT Account Specific No Carton: UPC 300676238944
• Excedrin® Back & Body Caplets 100CT New Label: UPC 300676238913
• Excedrin® Back & Body Caplets 24CT New Label: UPC
• 300676238241
• Excedrin® Back & Body Caplets 50CT New Label: UPC
• 300676238500
• Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000927
• Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000941
• Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000941
• Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000910
• Excedrin® Extra Strength Caplets 100CT: UPC 300672000910
• Excedrin® Extra Strength Caplets 125CT Bonus Pack: UPC 300672000835
• Excedrin® Extra Strength Caplets 125CT Bonus Pack Account Specific:UPC 300672000842
• Excedrin® Extra Strength Caplets 125CT New Carton: UPC 300672000866
• Excedrin® Extra Strength Caplets 24+6CT Bonus Pack: UPC 300672000309
• Excedrin® Extra Strength Caplets 24CT: UPC 300672000248
• Excedrin® Extra Strength Caplets 24CT New Label: UPC 300672000248
• Excedrin® Extra Strength Caplets 250CT No Carton: UPC 300672000071
• Excedrin® Extra Strength Caplets 250CT No Carton New Label: UPC 300672000071
• Excedrin® Extra Strength Caplets 250CT Special Inner: UPC 300672000774
• Excedrin® Extra Strength Caplets 250CT New Label: UPC 300672000774
• Excedrin® Extra Strength Caplets 300CT Bonus Pack: UPC 300672000552
• Excedrin® Extra Strength Caplets 50CT New Label: UPC 300672000507
• Excedrin® Extra Strength Caplets 50S: UPC 300672000507
• Excedrin® Extra Strength Express Gel Caps 20CT New Label: UPC 300676270203
• Excedrin® Extra Strength Express Gel Caps 40CT New Label: UPC 300676270401
• Excedrin® Extra Strength Express Gel Caps 80CT Account Specific: UPC 300676270814
• Excedrin® Extra Strength Express Gel Caps 80CT: UPC 300676270807
• Excedrin® Extra Strength Express Gel Caps 80CT Account Specific: UPC 300676270944
• Excedrin® Extra Strength Gel Tablets 24CT: UPC 300672021243
• Excedrin® Extra Strength Tablets 100CT Special Inner: UPC
• 300672030917
• Excedrin® Extra Strength Tablets 100CT Account Specific: UPC 300672030931
• Excedrin® Extra Strength Tablets 100CT Account Specific: UPC 300672030948
• Excedrin® Extra Strength Tablets 100CT New Label: UPC 300672030917
• Excedrin® Extra Strength Tablets 125CT Bonus Pack: UPC 300672030832
• Excedrin® Extra Strength Tablets 125CT Bonus Pack New Carton: UPC 300672030863
• Excedrin® Extra Strength Tablets 200CT New Label: UPC 300672030924
• Excedrin® Extra Strength Tablets 24+6CT Bonus Pack: UPC 300672030306
• Excedrin® Extra Strength Tablets 24CT: UPC 300672030245
• Excedrin® Extra Strength Tablets 24CT New Label: UPC 300672030245
• Excedrin® Extra Strength Tablets 250+50CT Bonus Pack: UPC 300672030573
• Excedrin® Extra Strength Tablets 250CT No Carton: UPC 300672030078
• Excedrin® Extra Strength Tablets 250CT No Carton New Label: UPC 300672030078
• Excedrin® Extra Strength Tablets 250CT Special Inners: UPC 300672030771
• Excedrin® Extra Strength Tablets 250CT New Label: UPC 300672030771
• Excedrin® Extra Strength Tablets 300CT New Carton: UPC 300672030337
• Excedrin® Extra Strength Tablets 300CT Club Tray: UPC 300672030337
• Excedrin® Extra Strength Tablets 300CT New Label: UPC 300672030337
• Excedrin® Extra Strength Tablets 300S: UPC 300672030337
• Excedrin® Extra Strength Tablets 50CT: UPC 300672030504
• Excedrin® Extra Strength Tablets 50CT New Label: UPC 300672030504
• Excedrin® Extra Strength Tablets 8CT: UPC 300672030085
• Excedrin® Extra Strength Tablets 8CT New Label: UPC 300672030085
• Excedrin® Migraine Express Gel Caplets 20CT New Label: UPC 300676341200
• Excedrin® Migraine Caplets 100CT: UPC 300672039910
• Excedrin® Migraine Caplets 100CT Account Specific: UPC 300672039941
• Excedrin® Migraine Caplets 100CT Account Specific No Carton: UPC 300672039941
• Excedrin® Migraine Caplets 100CT Account Specific: UPC 300672043917
• Excedrin® Migraine Caplets 100CT New Label: UPC 300672039910
• Excedrin® Migraine Caplets 125CT Bonus Pack No Carton: UPC 300672039842
• Excedrin® Migraine Caplets 125CT Bonus Pack New Carton: UPC 300672039866
• Excedrin® Migraine Caplets 125CT Bonus Pack: UPC 300672039835
• Excedrin® Migraine Caplets 200CT New Label: UPC 300672039927
• Excedrin® Migraine Caplets 24+6CT Bonus Pack: UPC 300672039309
• Excedrin® Migraine Caplets 24CT: UPC 300672039248
• Excedrin® Migraine Caplets 24CT New Label: UPC 300672039248
• Excedrin® Migraine Caplets 250+50CT Bonus Pack: UPC 300672039576
• Excedrin® Migraine Caplets 250CT No Carton: UPC 300672039071
• Excedrin® Migraine Caplets 250CT No Carton New Label: UPC 300672039071
• Excedrin® Migraine Caplets 250CT Special Inners: UPC 300672039774
• Excedrin® Migraine Caplets 250CT New Label: UPC 300672039774
• Excedrin® Migraine Caplets 300CT: UPC 300672039330
• Excedrin® Migraine Caplets 300CT New Carton: UPC 300672039330
• Excedrin® Migraine Caplets 300CT New Label: UPC 300672039330
• Excedrin® Migraine Caplets 300CT Club Tray: UPC 300672039330
• Excedrin® Migraine Caplets 50CT New Label: UPC 300672039507
• Excedrin® Migraine Caplets 50CT: UPC 300672039507
• Excedrin® Migraine Caplets 8CT New Label: UPC 300672039088
• Excedrin® Migraine Gel Tablets 160CT: UPC 300672035165
• Excedrin® Migraine Gel Tablets 100CT Special Inner: UPC 300672035912
• Excedrin® Migraine Gel Tablets 100CT New Label: UPC 300672035912
• Excedrin® Migraine Gel Tablets 100CT Account Specific: UPC 300672044914
• Excedrin® Migraine Gel Tablets 24CT – New Label: UPC 300672035240
• Excedrin® Migraine Gel Tablets 2X50CT: UPC 300672035936
• Excedrin® Migraine Gel Tablets 50CT New Label: UPC 300672035509
• Excedrin® Migraine Tablets 100CT Special Inner: UPC 300672037916
• Excedrin® Migraine Tablets 100CT New Label: UPC 300672037916
• Excedrin® Migraine Tablets 125CT Bonus Pack: UPC 300672037831
• Excedrin® Migraine Tablets 24+6CT Bonus Pack: UPC 300672037305
• Excedrin® Migraine Tablets 24CT: UPC 300672037244
• Excedrin® Migraine Tablets 24CT New Label: UPC 300672037244
• Excedrin® Migraine Tablets 250CT Special Inner: UPC 300672037770
• Excedrin® Migraine Tablets 250CT New Label: UPC 300672037770
• Excedrin® Migraine Tablets 50CT: UPC 300672037503
• Excedrin® Migraine Tablets 50CT New Label: UPC 300672037503
• Excedrin® PM Caplets 100CT New Label: UPC 300672055910
• Excedrin® PM Caplets 125CT Bonus Pack New Carton: UPC 300672055866
• Excedrin® PM Caplets 24CT New Label: UPC 300672055248
• Excedrin® PM Caplets 50CT New Label: UPC 300672055507
• Excedrin® PM Express Gel Caplets 20CT: UPC 300676405209
• Excedrin® PM Express Gel Caplets 80CT Account Specific: UPC 300676405810
• Excedrin® PM Express Gel Caplets 80CT No Carton: UPC 300676409801
• Excedrin® PM Express Gel Caplets 80CT New Label: UPC 300676405803
• Excedrin® PM Tablets 100CT Account Specific: UPC 300672053923
• Excedrin® PM Tablets 100CT Account Specific No Carton: UPC 300672053947
• Excedrin® PM Tablets 100CT New Label: UPC 300672053916
• Excedrin® PM Tablets 125CT Bonus Pack: UPC 300672053831
• Excedrin® PM Tablets 24+6CT Bonus Pack: UPC 300672053305
• Excedrin® PM Tablets 24CT New Label: UPC 300672053244
• Excedrin® PM Tablets 50CT New Label: UPC 300672053503
• Excedrin® PM Tablets 8CT New Label: UPC 300672053084
• Excedrin® Sinus Headache Caplets 24CT New Label: UPC 300672062246
• Excedrin® Tension Headache Caplets 100CT Special Inner: UPC 300672045911
• Excedrin® Tension Headache Caplets 100CT Account Specific No Carton:UPC 300672045942
• Excedrin® Tension Headache Caplets 100CT Account Specific No Carton New Label: UPC 300672045942
• Excedrin® Tension Headache Caplets 100CT Account Specific: UPC 300672045959
• Excedrin® Tension Headache Caplets 100CT New Label: UPC 300672045911
• Excedrin® Tension Headache Caplets 125CT Bonus Pack: UPC 300672045836
• Excedrin® Tension Headache Caplets 125CT Bonus Pack No Carton: UPC 300672045843
• Excedrin® Tension Headache Caplets 24+6CT Bonus Pack: UPC 300672045300
• Excedrin® Tension Headache Caplets 24CT Special Inner: UPC 300672045249
• Excedrin® Tension Headache Caplets 24CT New Label: UPC 300672045249
• Excedrin® Tension Headache Caplets 250CT: UPC 300672045775
• Excedrin® Tension Headache Caplets 250CT No Carton: UPC 300672045072
• Excedrin® Tension Headache Caplets 50CT Special Inner: UPC 300672045508
• Excedrin® Tension Headache Caplets 50CT New Label: UPC 300672045508
• Excedrin® Tension Headache Express Gel Caplets 20CT: UPC 300676272207
• Excedrin® Tension Headache Express Gel Caplets 40CT: UPC 300676272405
• Excedrin® Tension Headache Express Gel Caplets 80CT Account Specific: UPC 300676272948
• Excedrin® Tension Headache Express Gel Caplets 80CT: UPC 300676272801
• Excedrin® Tension Headache Gel Tablets 24CT New Label: UPC 300672050243
• Gas-X® Prevention® Caplets 20CT: UPC 300433005208
• Gas-X® Prevention® Caplets 50CT: UPC 300433005505
• NoDoz® Maximum Strength Caplets 16CT: UPC 300672070166
• NoDoz® Maximum Strength Caplets 16CT New Graphic: UPC 300672070166
• NoDoz® Maximum Strength Caplets 36CT: UPC 300672070364
• NoDoz® Maximum Strength Caplets 36CT New Graphic: UPC
• 300672070364
• NoDoz® Maximum Strength Caplets 60CT: UPC 300672070609
• NoDoz® Maximum Strength Caplets 60CT New Graphic: UPC 300672070609

Excedrin Extra Strength and Excedrin Tension Headache were recalled in Canada.

Visit our marketplace for details on this recall and for Novartis contact information.

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