Product Recalls: January 17, 2024 – February 14, 2024
Health Letter, March 2024
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
Zenzedi (dextroamphetamine sulfate) CII tablets, 30 mg, 30-count bottle. Manufactured for: Arbor Pharmaceuticals, LLC. Lot # F230169A, exp. date: 06/30/2025.
CLASS II
budesonide extended-release tablets, 9 mg, 30-count bottle. Manufactured by: Actavis Laboratories FL, Inc. Lot #: 100047273; exp. date: 07/2025.
cinacalcet tablets, 60 mg, 30 tablets per bottle. Distributed by: Sun Pharmaceutical Industries, Inc. Manufactured by: Sun Pharmaceutical Industries Limited. Lot #: DNE0702A, exp. date: 06/30/2026.
febuxostat tablets, 40 or 80 mg, 30 tablets per bottle or carton. Distributed by: Sun Pharmaceutical Industries, Inc., or American Health Packaging. Manufactured by: Sun Pharmaceutical Industries Ltd. Lot #: DNE0866B, exp. date: 06/30/2025; Lot #: DNE1045A or DNE1046B, exp. date: 08/31/2025; Lot #: DNE0867A, exp. date: 06/30/2025; Lot #: DNE0894B, exp. date: 07/31/2025; Lot #: 1015033, exp. date: 06/30/2025; Lot #: 1016409, exp. date: 08/31/2025.
fexofenadine hydrochloride tablets; 180 mg; 30, 45 or 150 tablets per bottle. Distributed by: Ohm Laboratories Inc. or CVS Pharmacy, Inc. Lot #: DNE0792A, exp. date: 06/31/2025; Lot #: DNE1027A, exp. date: 08/31/2025; Lot #: DNE0793A, exp. date: 06/31/2025; Lot #: DNE0789A, DNE0790A or DNE0791A, exp. date: 06/2025; Lot #: DNE1026A, exp. date: 08/31/025.
ibuprofen and famotidine tablets, 800 mg/26.6 mg, 90 tablets per bottle. Manufactured by: Alkem Laboratories Ltd. Lot #: 23140190, exp. date: 12/31/2024.
lansoprazole delayed-release capsules, 15 mg, 14-count bottle. Manufactured by: Natco Pharma Limited. Lot #: 411987, exp. date: 05/2025.
lurasidone hydrochloride tablets, 60 or 120 mg, 30 tablets per bottle. Distributed by: Sun Pharmaceutical Industries, Inc. Manufactured by: Sun Pharmaceutical Industries Ltd. Lot #: DNE0620A, exp. date: 05/31/2025; Lot #: DNE0621A, exp. date: 11/30/2024; Lot #: DNE0815A, exp. date: 12/31/2024.
mesalamine delayed-release tablets, 1.2 g per tablet, 120 tablets per bottle. Distributed by: Sun Pharmaceutical Industries, Inc. Manufactured by: Sun Pharmaceutical Industries Limited. Lot #: DNE0875A, exp. date: 01/31/2025; Lot #: DNE0876A, DNE0877A, DNE1080A or DNE1081A, exp. date: 02/28/2025; Lot #: DNE1147A or DNE1148A, exp. date: 03/31/2025.
methoxsalen capsules, 10 mg, 50-count bottle. Manufactured by: Strides Pharma Science Ltd. Lot #: 7253092B, exp. date: 09/30/2025.
niacin extended-release tablets, 500 or 1,000 mg, 90 tablets per bottle. Distributed by: Sun Pharmaceutical Industries, Inc. Manufactured by: Sun Pharmaceutical Industries Limited. Lot #: DNE0788A, exp. date: 07/31/2025; Lot #: DNE0771A, exp. date: 06/30/2025; Lot #: DNE0857A or DNE0959A, exp. date: 07/31/2025.
phenoxybenzamine hydrochloride capsules, 10 mg, 100-count bottle. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Lot #: AM221153, exp. date: 06/30/2024; Lot #: AM230497, exp. date: 02/29/2025.
rifampin capsules, 150 or 300 mg, 30-count bottle. Manufactured for: Lupin Pharmaceuticals, Inc., or Distributed by: American Health Packaging. Lot #: A200816, exp. date: 1/2024; Lot #: A201248, exp. date: 3/2024; Lot #: A200817, exp. date: 1/2024; Lot #: 1008111, exp. date: 01/31/2024.
zolpidem tartrate extended-release tablets, 6.25 or 12.5 mg, 100 tablets per bottle. Distributed by: Sun Pharmaceutical Industries, Inc. Manufactured by: Sun Pharmaceutical Industries Limited. Lot #: DNE0892A, exp. date: 07/31/2026; Lot #: DNE0893A, exp. date: 07/31/2026.
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/.