FDA enforcement

FDA drug recalls, October 26 to November 1, 2026

FDA posted 29 drug recalls the week of October 26, 2026: 3 Class I, 25 Class II, and 1 Class III. PRITAM INTERNATIONAL PRIVATE LIMITED has the most, with 17.

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FDA sorts recalls by risk. Class I: using the product could cause serious health problems or death. Class II: it could cause temporary or reversible health problems. Class III: it is unlikely to cause health problems.

Recalls posted October 26 to November 1, 2026

Class I · Posted October 28, 2026 · Started October 13, 2026 · Ongoing

argatroban

Product
Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, NDC 42023-182-89.
Firm
Par Health USA, LLC, Rochester, MI
Reason
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Lots
Lot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027.
Quantity
1944 vials
Distribution
Nationwide within the United States
RxNorm
argatroban (RxCUI 308351)
Recall number
D-0083-2027

Class I · Posted October 28, 2026 · Started October 13, 2026 · Ongoing

argatroban

Product
Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-182-01.
Firm
Par Health USA, LLC, Rochester, MI
Reason
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Lots
Lot #: 83449, Exp Date: 10/2026; 82682, Exp Date: 11/2026; 86714, 87302, 87560, Exp Date: 02/2027; 87753, 88401, Exp Date: 03/2027; 88614, 88836, Exp Date: 04/2027; 90220, Exp Date: 05/2027; 91216, 91219, Exp Date: 06/2027; 92004, 92006, Exp Date: 07/2027; 92009, 92596, 92782, 93107, 93329, Exp Date: 08/2027; 93890, Exp Date: 09/2027.
Quantity
18,991 vials
Distribution
Nationwide within the United States
RxNorm
argatroban (RxCUI 308351)
Recall number
D-0082-2027

Class II · Posted October 28, 2026 · Started October 9, 2026 · Ongoing

Testosterone Cypionate

Product
Testosterone Cypionate, 200 mg/mL, packaged in a) 5 mL vials (NDC 73271-1225-1) and b) 30 m vials ( NDC 73271-1226-2) This Is A Compounded Dug, Intramuscular Use, Office Use Only, 8400 Esters Blvd, STE 190, Irving, TX 75063.
Firm
Right Value Drug Stores LLC, Irving, TX
Reason
Lack of sterility assurance.
Lots
a) Lot 10212025@3, BUD 10/21/2026; 10292025@4, BUD 10/29/2026; 10282025@6, BUD: 10/29/2026; 12012025@1, BUD: 12/01/2026; 04072026@1, BUD: 04/01/2027; 05262026@3, BUD 05/08/2027; 05262026@7, BUD 11/17/2026; 05272026@1, BUD 05/08/2027; 05272026@2, BUD: 11/22/2026; 07032026@1, BUD 05/08/2027; 07022026@1, BUD: 05/08/2027; 07062026@3, BUD: 05/08/2027; 07072026@3, BUD: 12/30/2026. b) 04012026@2, BUD 04/01/2027.
Quantity
4675 vials
Distribution
Nationwide in the USA.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0070-2027

Class II · Posted October 28, 2026 · Started October 7, 2026 · Ongoing

cinacalcet

Product
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, 605 014, India; Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807, NDC 64380-883-04
Firm
STRIDES PHARMA INC, Bridgewater, NJ
Reason
Failed dissolution specifications
Lots
Lot # 7717825A, Expiry: 11/30/2028.
Quantity
49,488 30-count bottles
Distribution
US Nationwide
RxNorm
cinacalcet (RxCUI 432400, 432401, 432402)
Recall number
D-0079-2027

Class II · Posted October 28, 2026 · Started October 6, 2026 · Ongoing

abiraterone acetate

Product
Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922 USA by: Arab Pharmaceuticals Manufacturing PSC PO Box 41, Sahab-Jordon, NDC 82249-011-12.
Firm
Hikma Pharmaceuticals USA INC., Columbus, OH
Reason
Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
Lots
Lot #: 3047, Exp Date July 2027.
Quantity
2136 bottles
Distribution
Nationwide within the United States
RxNorm
abiraterone acetate (RxCUI 1100075, 2702601)
Recall number
D-0076-2027

Class II · Posted October 28, 2026 · Started October 6, 2026 · Ongoing

amlodipine and olmesartan medoxomil

Product
Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-502-30.
Firm
Ascend Laboratories, LLC, Bedminster, NJ
Reason
Out of specification due to dissolution.
Lots
Lot # 25120696, Exp Date: December 31, 2026.
Quantity
11,424 bottles.
Distribution
Nationwide within the United States
RxNorm
amlodipine and olmesartan medoxomil (RxCUI 730861, 730866, 730869, 730872)
Recall number
D-0045-2027

Class II · Posted October 28, 2026 · Started October 2, 2026 · Ongoing

amitriptyline hydrochloride

Product
Amitriptyline Hydrochloride, Tablets, USP, 10 mg, 5 x 10 Unit dose cards in paper cartons, Rx only, Manufactured for AvKARE, Pulaski, TN 38478, NDC 50268-037-15.
Firm
AvKARE, Pulaski, TN
Reason
Failed dissolution specifications.
Lots
Lot # 48489, Expiry: 12/31/2026
Quantity
3534 50-count cartons
Distribution
US Nationwide.
RxNorm
amitriptyline hydrochloride (RxCUI 856783, 856834, 856845, 856853)

Class I · Posted October 28, 2026 · Started October 1, 2026 · Ongoing

Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic…

Product
Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dose vial, Rx only, Subcutaneous Only, Greenwich Rx.
Firm
Greenwich Rx, Tomball, TX
Reason
Microbial Contamination of Sterile Products
Lots
Lot # 0060-062426-1, BUD: 10/02/2026; Lot # 0060-062726-1, BUD: 10/05/2026; Lot # 0060-070926-1, BUD: 10/17/2026; Lot # 0060-071426-1, BUD: 10/22/2026; Lot #0060-071426-2, BUD: 10/22/2026; Lot # 0060-072026-1, BUD: 10/28/2026; Lot # 0060-072726-1, BUD: 11/04/2026; Lot #0060-072926-1, BUD: 11/06/2026; Lot # 0060-073126-1; BUD: 11/08/2026; Lot # 0060-080426-1, BUD: 11/12/2026; Lot #: 0060-080526-1, BUD: 11/13/2026; Lot # 0060-081826-1, BUD: 11/26/2026.
Quantity
4,319 vials
Distribution
US Nationwide in th USA
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0084-2027

Class II · Posted October 28, 2026 · Started October 1, 2026 · Ongoing

heparin sodium

Product
Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, Distributed by: Hepalink USA Inc., Langhome, PA 19047-1885. Carton NDC: NDC 81952-111-06, Vial NDC: 81942-111-01
Firm
Shenzhen Techdow Pharmaceutical Co., Ltd., Shenzhen, China
Reason
Lack of Assurance of Sterility
Lots
Lot# CU03232A, Exp 1/31/2028
Quantity
251,000 1 mL multidose vials
Distribution
Nationwide in the USA.
RxNorm
heparin sodium (RxCUI 1361226, 1361574, 1361615, 1362831, 1658647)
Recall number
D-0050-2027

Class III · Posted October 28, 2026 · Started October 1, 2026 · Ongoing

telmisartan and amlodipine

Product
Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93.
Firm
Viatris, Inc., Morgantown, WV
Reason
Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
Lots
Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.
Quantity
21,620 30-count bottles
Distribution
Nationwide in the USA.
RxNorm
telmisartan and amlodipine (RxCUI 876514, 876519, 876524, 876529)
Recall number
D-0049-2027

Class II · Posted October 28, 2026 · Started September 29, 2026 · Ongoing

levothyroxine sodium

Product
Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-01.
Firm
Pfizer, Manhattan, NY
Reason
Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
Lots
Lot # 24W06, Exp: 11/30/2026
Quantity
15,815 100-count bottles
Distribution
US Nationwide and Puerto Rico
RxNorm
levothyroxine sodium (RxCUI 892246, 892251, 966157, 966164, 966170, +17 more)
Recall number
D-0052-2027

Class II · Posted October 28, 2026 · Started September 29, 2026 · Ongoing

levothyroxine sodium

Product
Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-10
Firm
Pfizer, Manhattan, NY
Reason
Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
Lots
Lot # 24W07, Exp: 11/30/2026
Quantity
134 1000-count bottles
Distribution
US Nationwide and Puerto Rico
RxNorm
levothyroxine sodium (RxCUI 892246, 892251, 966157, 966164, 966170, +17 more)
Recall number
D-0051-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

ARU

Product
ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-785-35, Item # 88785, UPC 8 10147 88785
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations.
Lots
Lot # LWP250047850611C, Exp Date: 12/22/2027; Lot # LWP260052612201C, Exp Date: 3/31/2028.
Quantity
15,264 tubes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0069-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

ARU

Product
ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-786-35, Item # 88786 UPC 8 10147 88786 6
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations.
Lots
Lot # LWP250047850611D, Exp Date: 12/23/2027; Lot # LWP260052612201D, Exp Date: 04/30/2028.
Quantity
15,264 tubes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0068-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

BB (Brush Buddies) Advanced Whitening

Product
BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0,24%) Peppermint, Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-885-42, Item # 88542, UPC 8 10147 88542 8
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations.
Lots
Lot # LWP250036560205A, Exp Date: 05/25/2027; Lot # LWP250038232805A, Exp Date: 06/19/2027; Lot # LWP0054880903D, Exp Date: 01/28/2028; Lot # LWP260056333003C, Exp Date: 06/04/2028.
Quantity
198,288 tubes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0067-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

BB (Brush Buddies) Cavity Protection

Product
BB (Brush Buddies) Cavity Protection, Anti-Cavity Fluoride Toothpaste, (sodium monofluorophosphate 0.76%) Cool Mint, 2 Value Pack, Two 3.5 oz (99g) tubes, Total Net Wt 7 oz (198g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-035-10, Item # 88543, UPC 8 10147 88543 5
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations.
Lots
Lot# LWP250036560205B, Exp Date: 05/26/2027; Lot# LWP250038232805B, Exp Date: 06/22/2027; Lot# LWP250051182312A, Exp Date: 02/09/2028; Lot# LWP0054880903E, Exp Date: 04/30/2028; Lot# LWP260056333003D, Exp Date: 05/24/2028.
Quantity
231,936 tubes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0066-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

Brush Buddies

Product
Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda, (sodium monofluorophosphate 0.76%) Cool Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-007-07, ITEM # 999131, 8 50010 84249 3
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations.
Lots
Lot # LWP250032331302B, Exp Date: 02/23/2027; Lot # LWP250034892603, Exp Date: 04/07/2027; Lot # LWP250032581702, Exp Date: 04/14/2027; Lot # LWP250045162409, Exp Date: 10/17/2027; Lot # LWP250032331302A, LWP250047640511A, Exp Date: 12/20/2027; Lot # LWP250051162312B, Exp Date: 01/04/2028; Lot # LWP0054880903B, Exp Date: 04/08/2028; Lot # LWP260056333003A, Exp Date: 05/15/2028.
Quantity
797,868 tubes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0065-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

Brush Buddies

Product
Brush Buddies, Chocolate Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-518-35, Item # 88518, UPC 8 10147 88518 3
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations.
Lots
Lot# LWP250037221405, Exp Date: 07/04/2027; Lot# LWP250048151011, Exp Date: 11/11/2027; Lot# LWP250051162312A, Exp Date: 02/08/2028; Lot# LWP0054880903C, Exp Date: 04/30/2028.
Quantity
112,092 tubes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0064-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

Brush Buddies

Product
Brush Buddies, Cookies 'n Cream Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-519-35, Item # 88519, UPC 8 10147 88519 0
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations.
Lots
Lot# LWP250037221405, Exp Date: 07/04/2027; Lot# LWP250048151011, Exp Date: 11/11/2027; Lot# LWP250051162312A, Exp Date: 02/08/2028; Lot# LWP0054880903C, Exp Date: 04/30/2028.
Quantity
112,092 tubes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0063-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

Brush Buddies

Product
Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-520-35, Item # 88520, UPC 8 10147 88520 6
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations.
Lots
Lot# LWP250037221405, Exp Date: 07/04/2027; Lot# LWP250048151011, Exp Date: 11/11/2027; Lot# LWP250051162312A, Exp Date: 02/08/2028; Lot# LWP0054880903C, Exp Date: 04/30/2028.
Quantity
112,092 tubes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0062-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

Brush Buddies

Product
Brush Buddies, Vanilla Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-517-35, Item # 88517, UPC 8 10147 88517 6
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations
Lots
Lot# LWP250037221405, Exp Date: 07/04/2027; Lot# LWP250048151011, Exp Date: 11/11/2027; Lot# LWP250051162312A, Exp Date: 02/08/2028; Lot# LWP0054880903C, Exp Date: 04/30/2028.
Quantity
112,092 tubes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0061-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

evo

Product
evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-620-35, Item # 88620 UPC8 10147 88620 3
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations.
Lots
Lot# LWP250038760606, Exp Date: 08/05/2027; Lot# LWP250045152409B, Exp Date: 10/07/2027; Lot# LWP250046862110B, Exp Date: 11/15/2027; Lot# LWP250047640511C, Exp Date: 12/15/2027; Lot# LWP250051172312B, Exp Date: 01/27/2028; Lot# LWP260052241401A, Exp Date: 03/20/2028; Lot# LWP260055532003, Exp Date: 04/12/2028.
Quantity
389,880 tubes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0060-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

evo

Product
evo, Advanced Whitening, Anticavity Fluoride Toothpaste, (sodium fluoride 0.24%) Peppermint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-886-19, Item# 88619, UPC 8 10147 88619 7
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations.
Lots
Lot# LWP250038750606, Exp Date: 08/03/2027; Lot# LWP250045152409A, Exp Date: 10/06/2027; Lot# LWP250046862110A, Exp Date: 11/11/2027; Lot# LWP250047640511B, Exp Date: 12/17/2027; Lot# LWP250051172312A, Exp Date: 01/25/2028; Lot# LWP250051182312B, Exp Date: 01/28/2028; Lot# LWP260052241401B, Exp Date: 03/18/2028; Lot# LWP0054880903F, Exp Date: 03/29/2028.
Quantity
405,336 tubes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0059-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

Brush Buddies

Product
Brush Buddies, My Little Pony Scents Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-008-40, Item# 88270, UPC 8 10147 88270 0.
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations.
Lots
Lot# LWP240022080309, Exp Date: 11/30/2026; Lot# LWP250035710304C, Exp Date: 04/23/2027.
Quantity
17,400 tupes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0058-2027

Class II · Posted October 28, 2026 · Started September 10, 2026 · Ongoing

Brush Buddies

Product
Brush Buddies, Crayola Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-005-40, Item # 32732, UPC 8 50048 32732 0
Firm
PRITAM INTERNATIONAL PRIVATE LIMITED, Haridwar, India
Reason
CGMP Deviations.
Lots
Lot # LWP240027561211, Exp Date: 12/07/2026; Lot # LWP250031970602, Exp Date: 02/28/2027; Lot # LWP250031980602, Exp Date: 03/11/2027; Lot # LWP250032381402, Exp Date: 03/17/2027; Lot # LWP250035680204, Exp Date: 04/30/2027; Lot # LWP250037682005A, Exp Date: 06/08/2027; Lot # LWP250048601811, Exp Date: 12/09/2027; Lot # LWP250051382412, Exp Date: 01/09/2028; Lot # LWP260053652002, LWP260054222502, Exp Date: 03/31/2028.
Quantity
320,232 tubes
Distribution
US Nationwide.
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0057-2027

Source: openFDA drug enforcement reports, as of October 28, 2026. Publisher page

About this data

Each row is one FDA drug enforcement report: one product from one firm. A week here is Monday to Sunday, keyed on the date FDA listed the recall in its weekly Enforcement Report. The date the firm started the recall is shown on each row and is often weeks earlier.

Class I means use of the product could cause serious health problems or death. Class II means it could cause temporary or reversible health problems. Class III means it is unlikely to cause health problems. RxNorm names and RxCUIs come from openFDA's match of the product to its drug label. Compounded products often have no match.

This page lists public records. It is not medical advice. Check the FDA record before acting on a recall.

Source: openFDA drug enforcement reports, as of October 28, 2026. Publisher page

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