Product Recalls: July 16, 2025 – August 13, 2025
Health Letter, September 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 benazepril HCl capsules, 2.5 mg/10 mg, 100-capsule bottle. Manufactured for: Lupin Pharmaceuticals, Inc. Manufactured by: Lupin Limited. Lot #: GB01616, exp. date: 2/28/2027.
cinacalcet tablets, 90 mg, 30-count bottles. Manufactured by: Strides Pharma Science Ltd. Lot #: 7715893A, exp. date: 12/31/2027.
clomiPRAMINE hydrochloride capsules, 25 mg, 100 count bottles. Lot #: M300464, exp. date: June 2025.
doxepin hydrochloride capsules, 10 mg, 100 capsules. Manufactured by: Alembic Pharmaceuticals Limited. Lot #: 2305015142, exp. date: 9/30/2025.
duloxetine delayed-release capsules; 20, 30 or 60 mg; 30-, 60-, 90- or 1,000-count bottle. Packaged & Distributed by: Direct Rx. Distributed by: Breckenridge Pharm., Inc. Lot #: 02AU2406, exp. date: 01/31/2027; Lot #: 15AU2420, 01JY2407 or 04OC2411, exp. date: 01/31/2027; Lot #: 12SE2418, 24OC2424 or 20NO2416, exp. date: 03/31/2027; Lot #: 21AU2313, 21JY2311 or 05JY2313, exp. date: 01/31/2026; Lot #: 13OC2310, 05SE2304, 04AU2306, 21JY2317 or 12JY2306, exp. date: 01/31/2026; Lot #: 11JY2416, 28JU2414, 19AU2412 or 02AU2409, exp. date: 01/31/2027; Lot #: 11SE2416 or 24OC2425, exp. date: 03/31/2027; Lot #: 23AU2317 or 21AU2314, exp. date: 01/31/2026; Lot #: 230836C, exp. date: 02/28/2026.
levothyroxine sodium tablets; 25, 50, 100, 112, 150 or 175 mcg (0.025, 0.05, 0.1, 0.112, 0.15 or 0.175 mg), 90- or 1,000-count bottle. Manufactured for: Accord Healthcare, Inc. Manufactured by: Intas Pharmaceuticals Limited. Lot #: D2300325, exp. date: 01/31/2026; Lot #: D2400536, exp. date: 02/28/2026; Lot #: D2400679, exp. date: 02/28/2026; Lot #: D2300087, exp. date: 12/31/2025; Lot #: D2300092, exp. date: 12/31/2025; Lot #: D2400722, exp. date: 03/31/2026; Lot #: D2300104, exp. date: 12/31/2025; Lot #: D2300076, exp. date: 12/31/2025; Lot #: D2300042, exp. date: 12/31/2025.
lisdexamfetamine dimesylate capsules, 60 mg, CII, 100-count bottles. Manufactured by: OHM Laboratories. Lot #: AD42648, exp. date: 02/28/2026.
lisinopril and hydrochlorothiazide tablets, 20 mg/12.5 mg, 100-count bottles. Manufactured for: Lupin Pharmaceuticals, Inc. Manufactured by: Lupin Limited. Lot #: QA01081, exp. date: April 2027.
omeprazole delayed-release capsules, 20 mg, 1,000-count bottle. Manufactured by: Dr. Reddy’s Laboratories Limited. Lot #: C2403017, exp. date: 12/31/2026.
rizatriptan benzoate tablets, 5 or 10 mg, 18 (3×6) unit dose tablets. Manufactured by: Alkem Laboratories Ltd. Lot #: 23142117, 23142119 or 23142122, exp. date: May 2026; Lot #: 24142625, exp. date: Jun. 2027; Lot #: 22143653 or 22143675, exp. date: July 2025; Lot #: 22144528, exp. date: September 2025; Lot #: 22144977, exp. date: November 2025; Lot #: 23140257, exp. date: December 2025; Lot #: 23140999, exp. date: Feb. 2026; Lot #: 23141900, 23142118, 23142120 or 23142123, exp. date: May 2026; Lot #: 23144563 or 23144565, exp. date: November 2026; Lot #: 24142623, exp. date: May 2027; Lot #: 24142624, 24142626 or 24143469, exp. date: Jun. 2027.
spironolactone tablets, 25 mg, 100-count bottle. Manufactured by: Frontida BioPharm, Inc. Lot #: P3314, exp. date: 11/30/2026.
sucralfate tablets, 1 gram, packaged in 100- or 500-count bottles. Manufactured by: Nostrum Laboratories, Inc. All lots.
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/.