Product Recalls: May 12, 2021 – June 16, 2021
Health Letter, July 2021
Note: Never stop taking a drug that appears on the product recall list without first talking to your doctor or pharmacist. Most recalls are limited to a single manufacturer and may not be related to the version of a particular drug you are taking. If a recall does relate to the version of the drug you are taking, you should not stop taking the drug until you discuss an alternative treatment with your doctor or pharmacist.
CLASS I
NP Thyroid 15 thyroid tablets, 1/4 grain (15 mg), 100- or 7-count bottles. Manufactured for: Acella Pharmaceuticals, LLC. Lot #: M327D20-1 or M327D20-3, exp. date: 03/31/2022; Lot #: M327H19-3A, exp. date: 07/31/2021; Lot #: M327L19-1, exp. date: 04/30/2021; Lot #: M327D20-1, exp. date: 03/31/2022.
NP Thyroid 30 thyroid tablets, 1/2 grain (30 mg), 100- or 7-count bottles. Manufactured for: Acella Pharmaceuticals, LLC. Lot #: M329D20-1, M329D20-2 or M329D20-3, exp. date: 03/31/2022; Lot #: M329D20-2, exp. date: 03/31/2022.
NP Thyroid 60 thyroid tablets, 1 grain (60 mg), 100-count bottles. Manufactured for: Acella Pharmaceuticals, LLC. Lot #: M330D20-1 or M330D20-2, exp. date: 03/31/2022; Lot #: M330J19-2A, M330J19-4A, M330J19-5A, M330J19-6A, M330J19-7A or M330J19-9A, exp. date: 08/31/2021; Lot #: M330K19-10, M330K19-1A or M330K19-9, exp. date: 09/30/2021.
NP Thyroid 90 thyroid tablets, 1&1/2 grain (90 mg), 100-count bottles. Manufactured for: Acella Pharmaceuticals, LLC. Lot #: M331J19-10A, M331J19-11, M331J19-2A or M331J19-6A, exp. date: 08/31/2021; Lot #: M331K19-1, M331K19-2 or M331K19-6, exp. date: 09/30/2021.
NP Thyroid 120 thyroid tablets, 2 grain (120 mg), 100- or 7-count bottles. Manufactured for: Acella Pharmaceuticals, LLC. Lot #: M328H19-2B, M328J19-11, M328J19-2A, M328J19-3A, M328J19-4A M328J19-5A, M328J19-6A or M328J19-7A, exp. date: 08/31/2021; Lot #: M328K19-2 or M328K19-4A, exp. date: 09/30/2021; Lot #: M328J19-9B, exp. date: 08/31/2021.
CLASS II
Acetazolamide tablets, 125 mg, 100 tablets. Manufactured for: Heritage Pharmaceuticals Inc. Lot #: M200833.
Amantadine hydrochloride tablets, 100 mg, 100-count bottle. Manufactured by: Upsher-Smith Laboratories, Inc. Lot #: 395310.
Amlodipine and olmesartan medoxomil tablets, 10 mg/20 mg, 30 tablets. Manufactured for: Macleods Pharma USA, Inc. Manufactured by: Macleods Pharmaceuticals Ltd. Lot #: BAD62005A.
Amoxicillin tablets, 500 mg, 100 tablets. Lot #: SE5019062-A.
Auryxia (ferric citrate) tablets, 210 mg, 200 tablets. Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc. Lot #: AN0142D.
Balziva 28 Day (norethindrone and ethinyl estradiol) tablets, 6 blister card dispensers, 28 tablets each. Manufactured for: Teva Pharmaceuticals USA, Inc. Lot #: 100016785.
Banophen (diphenhydramine HCl) capsules, 25 mg, 100 capsules. Distributed by: Major Pharmaceuticals. All lots distributed 02/23/2021 through 03/10/2021.
Banzel (rufinamide) tablets, 200 mg, 120 tablets. Manufactured by: Eisai Co., Ltd. Lot #: 80643.
Belsomra (suvorexant) tablets, 10 or 20 mg, 30 tablets in 3 blister cards. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Lot #: 1791139.
BENICAR tablets, 40 mg, 30 tablets. Lot #: 1703296.
Benztropine mesylate tablets, all pack sizes, styles and strengths. Manufactured for: Qualitest Pharmaceuticals. Lot #: S2008031.
Bisoprolol fumarate and hydrochlorothiazide tablets, 2.5 mg/6.25 mg, 100-count bottles. Distributed by: Teva Pharmaceuticals USA, Inc. Lot #: 1417295A.
Brilinta (ticagrelar) tablets, 60 mg, 60 tablets. Manufactured for: AstraZeneca LP. Lot #: MP0138.
Briviact (brivaracetam) tablets, 50 mg, 60-count bottle. Manufactured for UCB, Inc. Lot #: 309750.
Bupropion hydrochloride tablets, 75 mg, 100 tablets. Manufactured for: Heritage Pharmaceuticals Inc. Lot #: L200791.
Buspirone hydrochloride tablets, 15 mg, 100-count bottle. Manufactured by: Oxford Pharmaceuticals, LLC. Lot #: C21021A, exp. date: 03/2023.
Calcium acetate capsules, 667 mg, 200 capsules. Manufactured for: Heritage Pharmaceuticals Inc. Lot #: L200801.
Carbidopa and levodopa tablets, 25 mg/100 mg, 100 tablets. Lot #: FG12532.
Cetirizine hydrochloride tablets, 10 mg, 300 tablets. All Lots distributed 02/23/2021 through 03/10/2021.
Chantix (varenicline) tablets, Continuing Month Box contains: 4 Continuing Weeks (1 mg x 56 tablets). Distributed by: Pfizer Labs Division of Pfizer Inc. Lot #: EC5910 or EM1069.
Chantix (varenicline) tablets, Starting Pack contains: 1 Starting Week (0.5 mg x 11 tablets) and 3 Continuing Weeks (1 mg x 42 tablets). Distributed by: Pfizer Labs Division of Pfizer. Lot #: EC5911.
Clindamycin hydrochloride capsules, 150 mg, 100-count bottles. Manufactured by: Ohm Laboratories Inc. Lot #: AB77104.
Colcrys (colchicine) tablets, 0.6 mg, 30 tablets. Distributed by: Takeda Pharmaceuticals America, Inc. Lot #: 11888415.
Coreg CR (carvedilol phosphate) extended-release capsules, 80 mg, 30-count bottles. Lot #: P0978.
Corgard (nadolol) tablets, 40 mg, 100 tablets. Distributed by US WorldMeds, LLC. Lot #: 19T28.
Creon (pancrelipase) delayed-release capsules, dose by lipase units: lipase 36,000. Marketed by: AbbVie Inc. Lot #: 1139494.
Darifenacin extended-release tablets, 7.5 or 15 mg, 30 tablets. Manufactured by: Torrent Pharmaceuticals LTD. Lot #: BDZ7G005.
Desvenlafaxine extended-release tablets, 25 mg, 30 tablets. Manufactured by: Actavis Laboratories FL, Inc. Lot #: 1399650A.
Edarbi (azilsartan medoxomil) tablets, 80 mg, 30 tablets. Manufactured for: Arbor Pharmaceuticals. Lot #: 78902-1.
Edarbyclor (azilsartan medoxomil and chlorthalidone) tablets, 40 mg/12.5 mg or 40 mg/25 mg, 30 tablets. Manufactured for: Arbor Pharmaceuticals, LLC. Lot #: 78520 or 79551.
Eletriptan hydrobromide tablets, 20 mg, 6 (1×6) unit-dose tablets. Distributed by: Aurobindo Pharma USA, Inc. Lot #: EA2020001-A.
Enalapril maleate tablets, 2.5 mg, 100 tablets. Distributed by: Cardinal Health. Lot #: DV10467.
Erythromycin tablets, 250 mg, 30 tablets. Lot #: AM200540.
Eszopiclone tablets, 3 mg, 100 tablets. Lot #: GS0320010-A.
Ezetimibe and simvastatin tablets, 10 mg/10 mg, 30 tablets. Lot #: 17201603.
Fenofibrate capsules, 67 mg, 100 capsules. Lot #: PA03410.
Fexofenadine hydrochloride tablets, 180 mg, 100 tablets. Distributed by: Perrigo Allegan. All lots distributed 02/23/2021 through 03/10/2021.
Glyxambi (empagliflozin and linagliptin) tablets, 25 mg/5 mg, 30 tablets. Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Lot #: 3513.
Haloperidol tablets, 20 mg, 100-count bottle. Distributed by: Usher-Smith Laboratories, LLC. Lot #: 2007346C.
Ivermectin tablets, 3 mg, 20 tablets (2 soil Strips of 10 tablets each). Manufactured for: Edenbridge Pharmaceuticals, LLC. Lot #: A1003273A.
Jentadueto XR (linagliptin and metformin hydrochloride) extended-release tablets, 5 mg/1,000 mg, 30 tablets. Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Lot #: 3189866.
Lamotrigine extended-release tablets, 250 mg, 30 tablets. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Lot #: 10116.
Leucovorin tablets, 15 mg, 24 tablets. Lot #: 064159A.
Levoxyl tablets, 150 mcg, 100-count bottle. Distributed by Pfizer Inc. Lot #: 20D27.
Levothyroxine sodium tablets, 125 mcg (0.125 mg), 90 tablets. Mylan Pharmaceuticals Inc. Lot #: 3109046.
Linzess (linaclotide) capsules, 72 mcg/capsule, 30 capsules. Distributed by: Allergan. Lot #: W04411.
Lithium carb capsules, 150 mg, 100 capsules. Lot #: AB1024A.
Livalo (pitavastatin) tablets, 2 mg. Manufactured by: Patheon, Inc. Lot #: 3193479.
Loratadine tablets, 10 mg, 100 ND 24H. All lots distributed 02/23/2021 through 03/10/2021.
Lyrica (pregabalin) capsules, 200 mg, 90-count bottle. Distributed by: Parke-Davis, Division of Pfizer Inc. Lot #: CK1081.
Meloxicam tablets, 7.5 mg, 100 tablets. Manufactured for: Cipla USA. Lot #: KA03034.
Metformin HCl extended-release tablets, 500 mg, 100- or 500-count bottles. Manufactured by: Sun Pharmaceutical Industries Ltd. or Preferred Pharmaceuticals Inc. Lot #: JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX806A, JKX2945A, JKX2946A, JXK2947A, JKX2948A, JKX2952A, JKX2953A, JKX2954A or JKX3224A, exp. date: 6/2032; Lot #: JKX3211A or JKX3212A, exp. date: 7/2023; Lot # C2520W, exp. date: 12/31/2021; Lot #: E0620F, exp. date 12/31/2021; Lot #: G2020M, exp. date: 4/30/2022; Lot #: G2720A, exp. date: 4/30/2022.
Methocarbamol tablets, 500 mg, 500 tablets. Lot #: UMETA0036A.
Metoprolol tartrate and hydrochlorothiazide tablets, 50 mg/25 mg, 100 tablets. Manufactured for: Alembic Pharmaceuticals, Inc. Lot #: 2005005745.
Micardis (telmisartan) tablets, 80 mg, 30 per folding carton. Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Lot #: 860412; exp. date: SEPT 2022.
Nadolol tablets, 40 mg, 100 tablets. Manufactured for: Cipla USA Inc. Lot #: NB100156.
Namzaric (memantine HCl extended release and donepezil HCl) capsules, 14 mg/10 mg, 30 capsules. Distributed by: Forest Pharmaceuticals, Inc. Lot #: W04815.
Neomycin sulf tablets, 500 mg, 100-count bottle. Distributed by: Teva Pharmaceuticals USA, Inc. Lot #: 3006910.
Niacin tablets, 250 MG. All lots distributed 02/23/2021 through 03/10/2021.
Nitrofurantoin macrocrystals capsules, 25 mg, 100 capsules. Manufactured by: Norwich Pharmaceuticals, Inc. Lot #: 486942.
Norvir (ritonavir) tablets, 100 mg, 30 tablets. Abbott Laboratories. Lot # 1131141.
Nuedexta (dextromethorphan HBr and quinidine sulfate) capsules, 20 mg/10 mg, 60 capsules. Manufactured by Patheon, Inc. Lot #: CFBFP.
Ondansetron HCL tablets, 4 mg, 30 tablets. Lot #: ON0420015-A.
Orilissa elagolix tablets, 150 mg per tablet, equivalent to 155.2 mg elagolix sodium, 28 tablets for 28 days, 4-week blister pack, each weekly blister pack contains 7 tablets. AbbVie Inc. Lot #: 1120778.
Pantoprazole sodium delayed-release tablets, 20 mg, 90 tablets. Distributed by: Kremers Urban Pharmaceuticals Inc. Lot #: 20249489A.
Phenobarbital tablets, 32.4 mg, 100 tablets. Manufactured for: e5 Pharma, LLC. Lot #: 20ZHX2R.
Phentermine HCL capsules, 30 or 37.5 mg, 100 capsules. Lot #: 16667A or 16649A.
Pravachol tablets, 40 mg, 90 tablets. Lot #: ABA4203A1.
Pregabalin capsules, 300 mg, 90 capsules. Lot #: T2000309.
Rybelsus (semaglutide) tablets, 7 mg once daily, 30 tablets in 3 blister packs. Manufactured by: Novo Nordisk A/S. Lot #: K082347.
Steglatro (ertugliflozin) tablets, 15 mg, 30 tablets. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Lot #: T013566.
Sulindac tablets, 200 mg, 100-count bottles. Manufactured by: Epic Pharma, LLC. Lot #: 1578F201.
Symproic (naidemedine) tablets, 0.2 mg, 30 tablets. Lot #: 2003060A.
Synjardy (empagliflozin and metformin hydrochloride) tablets; 12.5 mg/1,000 mg or 25 mg/1,000 mg; 30 or 60 tablets. Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Lot #: C80102, 3191432 or 3190949.
Synthroid (levothyroxine sodium) tablets, in all pack sizes, styles and concentrations. Abbott Laboratories. Lot #: 1138959.
Theophylline (anhydrous) extended-release tablets, 400 mg, 100 tablets. Manufactured by: Glenmark Pharmaceuticals Limited. Lot #: 19205025.
Tirosint (levothyroxine sodium) capsules, 175 mcg, 3 blisters X 10 capsules. Lot #: 200606.
Tramadol hydrochloride tablets, 100 mg, 100-count bottle. Manufactured by: Rubicon Research. Lot #: 200340H1.
Trazodone hydrochloride tablets, 50 mg, 100 tablets. Lot #: R01580.
Tri-Lo-Marzia tablets, 0.180MG/0.025MG, 0.215 MG/0.025MG or 0.250MG/0.025MG, 3X28 BPK. Cardinal Health Inc. Lot #: L001911.
Triumeq (abacavir, dolutegravir, and lamivudine) tablets, 600 mg/50 mg/300 mg, 30 tablets. Manufactured for: Viiv Healthcare Research. Lot #: GS5G.
Trokendi XR (topiramate) extended-release capsules, 100 mg, 30 capsules. Manufactured by: Catalent Pharma Solutions. Lot #: 1741214.
Tylenol (acetaminophen) pain regular-strength liquid gels, 20 liquid gels, 325 mg. Cardinal Health Inc. All Lots distributed 02/23/2021 through 03/10/2021.
Ubrelvy tablets, 100 mg, 10UD CPLT. Lot #: 1658641.
Valsartan tablets, 40 mg, 30 scored tablets. Manufactured by: Jubilant Generics Ltd. Lot #: VR120022A.
Verapamil hydrochloride extended-release tablets, 120 mg. Manufactured by: Glenmark Generics Ltd. Lot #: 19205584.
Vimpat (lacosamide) tablets, 100 or 200 mg, 60-count bottle. Manufactured for: UCB, Inc. Lot #: 912056.
Vraylar (cariprazine) capsules, all pack sizes, styles and strengths. Distributed by: Actavis Pharma, Inc. Lot #: W04494.
Xigduo XR (dapgliflozin/metformin HCl) extended-release tablets, 5 mg/1,000 mg or 10 mg/1,000 mg, 30 or 60 tablets. Manufactured for: AstraZeneca Pharmaceuticals LP. Manufactured by: Bristol-Myers Squibb Manufacturing. Lot #: MP0077 or ML0171.
Zolpidem tartrate sublingual tablet, 3.5 mg, 30-unit dose pouches. Lot #: 12699501.
For more information about the drug recalls listed above, please visit http://www.accessdata.fda.gov/scripts/ires/index.cfm.
CONSUMER PRODUCTS
For a list of recent recalls of consumer products, please visit the Consumer Product Safety Commission website at http://www.cpsc.gov/en/Recalls/.