Product Recalls: August 13, 2025 – September 17, 2025
Health Letter, October 2025
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.
For Class 1 recalls, there is a potential for serious injury or death.
For Class 2 recalls, there is a potential for serious adverse events but a lower chance of the drug causing serious injury or death than in a Class 1 recall.
CLASS I
CLASS II
amlodipine and olmesartan medoxomil tablets, 5 mg/40 mg, 30-count bottle. Manufactured by: Alkem Laboratories Ltd. Lot #: 23121560, exp. date: 4/30/2026.
Belsomra (suvorexant) tablets, 10 mg, 30 tablets in 3 blister cards per carton. Manufactured by: Merck Sharp & Dohme LLC. Lot #: 2090019 or 2123744, exp. date: 4/30/2027.
carvedilol tablets; 3.125, 12.5 or 25 mg; 100- or 500-count bottle or carton. Manufactured by: Glenmark Pharmaceuticals Ltd. or Packaged and Distributed by: Major Pharmaceuticals. Lot #: 19242274, 19242275 or 19242272, exp. date: 5/31/20; Lot #: 19242272, exp. date: 5/31/2026; Lot#: 19243202, exp. date: 7/31/2026; Lot #: 19243104, exp. date: 7/31/2026; Lot #: 17241257, 17241258 or 17241279, exp. date: 06/2026; Lot #: 17241213, 17241215 or 17241224, exp. date: 06/2026; Lot #: T05693, exp. date: 03/2026.
chlorproMAZINE hydrochloride tablets; 10, 25, 50, 100 or 200 mg; 50- or 100-count bottles. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. or Zydus Lifesciences Ltd., or Manufactured for: AvKare. Lot #: AM240617 or AM240618, exp. date: 04/30/2027; Lot #: AM240147 or AM240148, exp. date: 01/31/2027; Lot #: AM240664 or AM240665, exp. date: 04/30/2027; Lot #: AM240334 or AM240335, exp. date: 02/28/2027; Lot #: AM241031, exp. date: 06/30/2027; Lot #: AM240336 or AM240337, exp. date: 02/28/2027; Lot #: Z403012, exp. date: 30-04-26; Lot #: Z406657, exp. date: 30-11-26; Lot #: 46824, exp. date: 9/30/25; Lot #: 47171, exp. date: 12/31/25; Lot#: Z403011, exp. date: 30-04-26; Lot #: Z407335, exp. date: 30-11-26; Lot #: Z305060 or Z305061, exp. date: 31-08-25; Lot #: Z306323, exp. date: 30-11-25; Lot #: Z401153, exp. date: 28-02-26; Lot #: Z403015 or Z403016, exp. date: 30-04-26; Lot #: Z405591, exp. date: 30-09-26; Lot #: Z305062, exp. date: 31-08-25; Lot #: Z306324, exp. date: 30-11-25; Lot #: Z401151 or Z401152, exp. date: 28-02-26; Lot #: Z306327, exp. date: 30-11-25; Lot #: Z306748, exp. date: 30-11-25; Lot #: Z401154, exp. date: 28-02-26; Lot #: Z403738, exp. date: 31-05-26; Lot #: Z405645, exp. date: 30-09-26; Lot #: Z306326, exp. date: 30-11-25; Lot #: Z401155, exp. date: 28-02-26; Lot #: Z305079 or Z305080, exp. Date: 30-09-25; Lot #: Z305454, Z305455, Z305457, Z400492, Z400493 or Z400494, exp. date: 31-12-25; Lot #: Z401158, Z401725 or Z401726, exp. date: 28-02-26; Lot #: Z404118, Z404119 or Z404120, exp. date: 30-06-26; Lot #: Z405648, exp. date: 30-09-26; Lot #: Z305456, exp. date: 31-10-25; Lot #: Z401156, exp. date: 28-02-26; Lot #: Z407306, exp. date: 30-11-26; Lot #: Z305083, Z305084, Z305468, Z305469 or Z305470, exp. date: 30-09-25; Lot #: Z401163 or Z401165, exp. date: 28-02-26; Lot #: Z402217 or Z402218, exp. date: 31-03-26; Lot #: Z405518 or Z405520, exp. date: 31-08-26; Lot #: Z406235, exp. date: 31-10-26; Lot #: Z305085, exp. date: 30-09-25; Lot #: Z401166 or Z401167, exp. date: 28-02-26; Lot #: 47089, exp. date: 12/31/25; Lot #: 47604, exp. date: 03/31/26.
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, 10 mg, 100 tablets per bottle. Distributed by: Lannett Company, Inc. Lot#: 25283185A. exp. date: 02/28/2027.
duloxetine delayed-release capsules, 30 or 60 mg, 1,000 capsules per bottle. Manufactured by: Towa Pharmaceutical Europe. Lot #: 240539C, exp. date: 1/31/2027; Lot #: 240927C, exp. date: 04/30/2027.
Levoxyl (levothyroxine sodium) tablets, 50 mcg, 100-count bottle. Distributed by: Pfizer Inc. Lot #: 24C11, exp. date: 2/28/2026.
lisdexamfetamine dimesylate capsules, 40 mg, 100-count bottles. Distributed by: Lannett Company, Inc. Lot #: 25280726A, exp. date: 03/2027.
metoprolol tartrate tablets, 50 or 100 mg, 1,000 Tablets. Manufactured by: Renata PLC. Batch #: R55230021, R55230031 or R55230041, exp. date: 9/30/25; Batch #: R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131 or R55230141, exp. date: 10/31/2025; Batch #: R55230151, exp. date: 11/30/25; Batch #: R55240011, exp. date: 12/31/25; Batch #: R55240021, R55240031, R55240041, R55240051 or R55240061, exp. date: 6/30/26; Batch #: R55240071, R55240081, R55240091, R55240101, R55240111 or R55240121, exp date: 7/31/26; Batch #: R56240011, exp. date: 2/28/26; Batch #: R56240021 or R56240031, exp. date: 3/31/26; Batch #: R56240041, R56240051 or R56240061, exp. date: 4/30/26; Batch #: R56240071, exp. date: 7/31/26.
sucralfate tablets, 1 g, 100 tablets (10×10). Distributed by: American Health Packaging. Lot #: 1015038, exp. date: 07/31/2025, Lot #: 1015898, exp. date: 09/30/2025; Lot #: 1016873, exp. date: 10/31/2025; Lot #: 1023398, exp. date: 07/31/2026.
sulfamethoxazole and trimethoprim tablets; 800mg/160mg, double strength; 10-, 100- or 500-count bottle or blister pack. Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd. or Packaged and Distributed by: Major Pharmaceuticals or Cardinal Health. Lot #: AM240173, exp. date: 01/31/2027; Lot #: AM240680, exp. date: 05/31/2027, Lot #: AM 240921, exp. date: 06/30/2027; Lot #: AM241191, exp. date: 08/31/2027. Lot #: AM240176 or AM240177, exp. date: 01/31/2027, Lot #: AM240301 or AM240300, exp. date: 02/28/2027; Lot #: AM240676 or AM240677, exp. date: 04/30/2027; Lot #: AM240678 or AM240679, exp. date: 05/30/2027 Lot #: AM240922, AM240923, AM240924 or AM240925, exp. date: 6/30/27, Lot #: AM241086, exp. date: 7/31/27; Lot #: AM241087 or AM241088, exp. date: 8/31/27; Lot # N02309, exp. date: 03/31/2027; Lot # N02309, exp. date: 03/31/2027.
theophylline extended-release tablets, 400 mg, 100-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited. Batch #: 19243193, 19243215, 19243231,19243248 or 19243283, exp. date: 7/31/2026; Batch #: 19244530 or 19244561, exp. date: 10/31/2026; Lot #: 19250178, exp. date: 12/31/2026.
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/.