Product Recalls: October 15, 2025 – November 12, 2025
Health Letter, December 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
Acetaminophen caffeine caplets, 500 mg/65 mg, packaged as 2 caplets per packet in a 50-count box, AERO TAB. Manufactured for AERO HEALTHCARE US. Lot #: 9282, exp. date: 2026-09-01; Lot #: 9310, exp. date: 2026-11-01.
Bupropion hydrochloride extended-release tablets, 300 mg, 30-count bottles. Manufactured by: Graviti Pharmaceuticals Private Limited or USV Private Limited. Batch #: BPB124341A, exp. date: 10/2026.
clomiPRAMINE hydrochloride capsules; 25, 50 or 75 mg; 30-, 90- or 100-count bottles. Manufactured for: Northstar Rx LLC. Lot #: E408871, exp. date: 10/2026; Lot #: E405282, exp. date: 06/2026; Lot #: E400386, exp. date: 12/2025; Lot #: E408872, exp. date: 10/2026; Lot #: E405280, exp. date: 06/2026; Lot #: E408873, exp date: 10/2026; Lot #: E405281, exp. date: 06/2026; Lot #: E400387, exp. date: 12/2025; Lot #: E410157, exp. date: 12/2026; Lot #: E407176, exp. date: 08/2026; Lot #: E405845, exp date: 06/2026; Lot #: E400943, exp. date: 01/2026; Lot #: E410156, exp. date: 12/2026; Lot #: E400942, exp. date: 01/2026; Lot #: E410158, exp. date: 12/2026; Lot #: E407128, exp. date: 08/2026; Lot #: E405846, exp. date: 06/2026; Lot #: E400944, exp. date: 01/2026.
Desipramine hydrochloride tablets; 10, 25, 50, 75, 100 or 150 mg; 50- or 100-count bottle. Manufactured by: USV Private Limited. Lot #: 18036908, exp. date: 09/30/2026; Lot #: 18035876, exp. date: 12/31/2025; Lot #: 18036909, exp. date: 09/30/2026; Lot #:18036713, exp. date: 08/31/2026; Lot #: 18036662, exp. date: 07/31/2026; Lot #: 18037649, exp. date: 03/31/2027; Lot #: 18035574, exp. date: 10/31/2025; Lot #: 18036758, exp. date: 08/31/2026; Lot #: 18035739, exp. date: 11/30/2025.
Duloxetine delayed-release capsules, 90- or 1000-count bottle. Manufactured by: Towa Pharmaceutical Europe. Lot #: 240721C, exp. date: 02/28/2027; Lot #: 230286C, exp. date: 02/28/2026.
Gabapentin capsules, 100 mg, 100 capsules (10 x 10 blister packs). Packaged and Distributed by: Major Pharmaceuticals. Lot #: M04950, exp. date: 01/2026; Lot #: M04989 or M04990, exp. date: 02/2026; Lot #: M05056, exp. date: 04/2026; Lot #: M05150, exp. date: 07/2026; Lot #: M05290, exp. date: 11/2026; Lot #: M05312 or M05342, exp. date: 01/2027; Lot #: M05369 or M05386, exp. date: 02/2027; Lot #: M04989A [Bag] or M04989 [Blister Pack], exp. date: 02/2026; Lot #: M05056A [Bag] or M05056 [Blister Pack], exp. date: 04/2026; Lot #: M05150A [Bag] or M05150 [Blister Pack], exp. date: 07/2026; Lot #: M05312A [Bag], M05312 [Blister Pack], M05342A [Bag] or M05342 [Blister Pack], exp. date: 01/2027.
Lisdexamfetamine dimesylate capsules, 10, 20, 30, 40, 50, 60 or 70 mg, 100-count bottle. Manufactured by: OHM Laboratories. Lot #: AD42468, exp. date: 2/28/2026; Lot #: AD48705, exp. date: 4/30/2026; Lot #: AD42469, exp. date:: 2/28/2026; Lot #: AD48707, exp. date: 4/30/2026; Lot #: AD42470, exp. date: 2/28/2026; Lot #: AD48708, exp. date: 4/30/2026; Lot #: AD48709, exp.: 4/30/2026; Lot #: AD50894, exp. date: 5/31/2026; Lot #: AD48710, exp. date: 4/30/2026; Lot#: AD50895, exp. date: 5/31/2026; Lot #: AD48711, exp. date: 4/30/2026; Lot #: AD50896, exp. date: 5/31/2026; Lot #: AD48712, exp. date: 4/30/2026; Lot #: AD50898, exp. date: 5/31/2026.
Niacin extended-release tablets, 1,000 mg, 90 tablets per bottle. Distributed by: Lannett Company, Inc. Lot #: expiry: 21264027A, exp. date: 10/30/2025; Lot #: 22266446A, exp. date: 12/31/2025; Lot #: 22266901A, exp. date: 02/28/2026; Lot #: 22267553A or 22267554A, exp. date: 03/31/2026; Lot #: 22267555A, exp. date: 02/28/2026; Lot #: 22267992A, exp. date: 04/30/2026; Lot #: 22267993A or 22267994A, exp. date: 05/31/2026.
Prazosin hydrochloride capsules; 1, 2 or 5 mg; 20, 100, 250, 500 or 1,000 capsules. Distributed by: TEVA PHARMACEUTICALS USA, INC. or American Health Packaging. Lot #: 3010544A or 3010545A, exp. date: 10/2025; Lot #: 3010567A, exp. date: 12/2025; Lot #: 3010590A, exp. date: 02/2026; Lot #: 3010601A, 3010602A or 3010603A, exp. date: 03/2026; Lot #: 3010652A, 3010670A or 3010671A, exp. date: 07/2026; Lot #: 3010678A, 3010700A or 3010701A, exp. date: 08/2026; Lot #: 3010440A, exp. date: 12/2025; Lot #: 3010672A, exp. date: 07/2026; Lot #: 3010398A, 3010399A, 3010400A, 3010401A or 3010353A, exp. date: 12/2025; Lot #: 3010439A or 3010388A, exp. date: 01/2026; Lot #: 3010526A or 3010527A, exp. date: 03/2026; Lot #: 3010591A, exp. date: 07/2026; Lot #: 3010343A, exp. date: 10/2025; Lot #: 3010352A, exp. date: 11/2025; Lot #: 3010468A, 3010469A or 3010461A, exp. date:02/2026; Lot #: 3010629A, exp date: 09/2026; Lot #: 3010653A, exp. date: 01/2027; Lot #: 3010654A, 3010679A or 3010702A, exp. date: 02/2027; Lot #: 3010547A, exp. date: 04/2026; Lot # 3010402A, exp. date: 02/2028; Lot #: 3010593A, exp. date: 07/2026; Lot #: 3010610A, exp. date: 09/2026; Lot # 3010403A, 3010385A or 3010404A, exp. date: 02/2026; Lot #: 3010405A, 3010510A, 3010528A or 3010354A, exp. date: 03/2026; Lot #: 3010592A, 3010605A, 3010611A or 3010612A, exp. date: 08/2026; Lot #: 3010655A or 3010703A, exp. date: 02/2027; Lot #: 3010430A, exp. date: 11/2025; Lot #: 3010613A, exp. date: 08/2026; Lot #: 3010406A, exp. date: 02/2026; Lot #: 1023526 or 1023555, exp. date: 07/31/2026; Lot #: 1020109, exp. date: 02/28/2026; Lot #: 1024343 or 1025355, exp. date: 09/30/2026; Lot #: 1016996, 1018336 or 1021220, exp. date: 11/30/2025; Lot #: 1022421 or 1025017, exp. date: 08/31/2026.
TYLENOL, acetaminophen, extra strength caplets, 500 mg, 24 count. Distributed by: Johnson & Johnson Consumer Inc. McNeil Consumer Healthcare Division. Lot #: EJA022, exp. date: 04/30/2028.
Viorele, desogestrel and ethinyl estradiol tablets; viorele/desogestrel tablets, 0.15 mg/ 0.02 mg, and ethinyl estradiol tablets, 0.01 mg; 3 blister cards each containing 28 tablets. Manufactured by: Glenmark Pharmaceuticals Limited. Batch #: 20230733, exp. date: October 2025.
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/.