Product Recalls: September 17, 2025 – October 15, 2025
Health Letter, November 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
cyclobenzaprine hydrochloride tablets, 10 mg, 90-count bottle. Manufactured by: Unichem Laboratories, Ltd. Lot #: GMML24026A, exp. date: 09/30/2027.
CLASS II
aripiprazole tablets, 10 mg, 30-count bottles. Manufactured by: Alken Laboratories Ltd. Lot #: 24144162, exp. date: 09/2027.
carbamazepine extended-release tablets, 400 mg, 30 tablets per carton (3×10 unit dose cards). American Health Packaging. Lot #: 1024078, exp. date: 08/31/2026.
chlorproMAZINE hydrochloride tablets; 25, 50, 100 or 200 mg; packaged as 50-count (5×10) or 100-count (10×10) blister packs. Distributed by: American Health Packaging. Lot #: 1020919 or 1021133, exp. date: 09/30/2026; Lot #: 1021447, exp. date: 10/31/2026; Lot #: 1021741 or 1022202, exp. date: 11/30/2026; Lot #: 1022474, exp. date: 12/31/2026; Lot #: 1020460, exp. date: 08/31/2026; Lot #: 1022417, exp. date: 12/31/2026; Lot #: 1022159, exp. date: 12/31/2026; Lot #: 1023299, exp. date: 03/31/2027; Lot #: 1024057, exp. date: 04/30/2027; Lot #: 1021652, exp. date: 10/31/2026; Lot #: 1022539, exp. date: 01/31/2027; Lot #: 1023666, exp. date: 03/31/2027; Lot #: 1021640, exp. date: 10/31/2026; Lot #: 1022639, exp. date: 01/31/2027.
doxycycline hyclate tablets, 100 mg, 500-count bottle. Distributed by: Acella Pharmaceuticals, LLC. Lot #: P24ZLK1, exp. date: 5/31/2027.
entecavir tablets, 0.5 or 1 mg, 30 tablets. Manufactured by: Zydus Lifesciences Ltd. Lot #: E309376, exp. date: 11/30/2025; Lot #: E309377, exp. date: 11/30/2025; Lot #: E409308, exp. date: 12/31/2026; Lot #: E409309, exp. date: 12/31/2026.
levothyroxine sodium tablets, 88 mcg (0.088 mg), 90 tablets per bottle. Manufactured for: Accord Healthcare, Inc. Manufactured by: Intas Pharmaceuticals Limited. Lot #: D2300045, exp. date: 12/31/2025.
Major chlorproMAZINE hydrochloride tablets; 25, 50, 100 or 200 mg, 50 tablets (5×10) or 100 tablets (10×10) blister package. Packaged and Distributed by: Major Pharmaceuticals. Lot #: N01943 or N02025, exp. date: 02/28/2026; Lot #: N01954, exp. date: 11/30/2025; Lot #: N02024, exp. date: 02/28/2026; Lot #: N02009 or N02026, exp. date: 02/28/2026; Lot #: N01920, exp. date: 12/31/2025; Lot #: N02023, exp. date: 02/28/2026; Lot #: N02202, exp. date: 06/30/2026; Lot #: N01928, exp. date: 09/30/2025; Lot #: N02008, exp. date: 03/21/2026; Lot #: N02071, exp. date: 02/28/2026.
norgestimate and ethinyl estradiol tablets; 0.18 mg/0.025 mg, 0.215 mg/0.025 mg or 0.25 mg/0.025 mg; 3 units, 3×28 tablets blister cards per carton. Manufactured for: AvKARE. Lot #: LF41138A, exp. date: 06/30/2027.
sulfamethoxazole and trimethoprim tablets; 800 mg/160 mg; double strength; packaged in 6-, 10-, 14- or 20-count bottles. Repackaged from: Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals. Lot #: F118062503, exp. date: 05/31/2027; Lot #: F118062507, exp. date: 07/31/2027; Lot #: F118062504 or F118062505, exp. date: 05/31/2027; Lot #: F118062509, exp. date: 08/31/2027; Lot #: F118062512, exp. date: 04/30/2027. Lot #: F118062506, exp. date: 06/30/2027; Lot #: F118062423, exp. date: 01/31/2027; Lot #: F118062501, exp. date: 06/30/2027; Lot #: F118062502, exp. date: 04/30/2027; Lot #: F118062508, exp. date: 08/31/2027.
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/.