Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
3 Class I (most serious) drug recalls reported in the last 30 days.
3,250 recalls
-
Class III Terminated
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16
Reason: Superpotent; sodium benzoate preservative
Lots, distribution and details
- Lots / codes
- Lot number 4B07, Exp Date: 2026-OCT-31
- Distribution
- OH
- Quantity
- 4080 Bottles
- Recall started
- January 7, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0222-2025
-
Class II Ongoing
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ…
Reason: Failed Dissolution Specifications.
Lots, distribution and details
- Product
- Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61
- Lots / codes
- Lot# T05224; Exp. 02/2026
- Distribution
- Nationwide in the USA
- Quantity
- 6997 cartons
- Recall started
- January 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0221-2025
-
Class II Ongoing
HydrALAZINE Hydrochloride, 100 Tablets (10×10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-32…
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- HydrALAZINE Hydrochloride, 100 Tablets (10×10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10
- Lots / codes
- Lot #: 0000127410, 63739-328-10, Exp. Date 30-Apr-2025; 0000127579, Exp. Date 31-Aug-2025; 0000128245, Exp. Date 31-Dec-2025; 0000128486, Exp. Date 28-Feb-2026.
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- January 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0220-2025
-
Class II Ongoing
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10×10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. N…
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10×10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10
- Lots / codes
- Lot #: 0000127312, Exp. Date 31-Mar-2025; 0000127576, 0000127577, Exp. Date 31-Jul-2025; 0000128204, Exp. Date 31-Dec-2025; 0000128358, Exp. Date 31-Jan-2026
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- January 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0219-2025
-
Class II Ongoing
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC…
Reason: Failed Stability Specifications – 12-month stability test result for one of the known peptides is below the specification limit
Lots, distribution and details
- Product
- Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.
- Lots / codes
- Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
- Distribution
- Product was distributed nationwide.
- Quantity
- 34,636 cartons
- Recall started
- January 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0218-2025
-
Class II Terminated
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
Reason: CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Lots, distribution and details
- Lots / codes
- Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.
- Distribution
- FL
- Quantity
- 247 blister packs
- Recall started
- January 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0217-2025
-
Class II Ongoing
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
Reason: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot numbers: a) 17230658, Exp.: 02/2025; 17230814,17230822, Exp.: 03/2025; 17231004,17231009,17231022, Exp.: 04/2025; 17231393,17231392, Exp.: 05/2025; 17231538, 17231541,17231542, Exp.: 06/2025; 17231710,17231718,17231721,17231722,17231730, Exp': 07/2025; 17232169, Exp.: 09/2025; 17232253, Exp.: 10/2025; 17240220,17240240, Exp.: 01/2026; 17240459, Exp.: 02/2026 b) 17230814, Exp.: 03/2025; 17231392, Exp.:05/2025; 17232260, Exp.: 10/2025.
- Distribution
- Nationwide in the U.S
- Quantity
- —
- Recall started
- January 22, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0216-2025
-
Class II Ongoing
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
Reason: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Lots, distribution and details
- Lots / codes
- Lot numbers: a) 17230500, 17230509,17230526,17230546,17230551,17230603,17230628, 17230642,17230645,17230681, Exp.:02/2025; 17230829,17230832,17230854, 17230864,17230874,17230876,17230889,17230894, Exp.: 03/2025; 17230960, 17230964,17230976,17230981,17230985,17231161,17231171, Exp.: 04/2025 17231315,17231318,17231332,17231333,17231365, Exp.: 05/2025; 17231539, 17231563, Exp.: 06/2025; 17231653,17231662,17231663,17231680,17231691, 17231781,17231782,17231789, Exp.: 07/2025;17231838,17231880, Exp.: 08/2025; 17232144,17232147,17232151, Exp.: 09/2025; 17232369,17232370,17232408,17232409, 17232416,17232504,17232522,17232531,17232538,17232543, Exp.: 11/2025; 17240377,17240385,17240415,17240422,17240430,17240510, Exp.: 02/2026. b) 17230551, 17240377, Exp.:02/2025
- Distribution
- Nationwide in the U.S
- Quantity
- —
- Recall started
- January 22, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0215-2025
-
Class II Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Lots, distribution and details
- Lots / codes
- Lot#: 083J033, Exp. Date 09/2025
- Distribution
- Distributed to one (1) Us Distributor in NJ
- Quantity
- 118104 bottles
- Recall started
- January 23, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0214-2025
-
Class II Ongoing
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01
Reason: cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Lots, distribution and details
- Lots / codes
- Lot# 04647349, Exp Date 5/31/2029
- Distribution
- Nationwide USA
- Quantity
- 192 vials
- Recall started
- January 17, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0213-2025
-
Class II Terminated
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3×10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10×10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major…
Reason: CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3×10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10×10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
- Lots / codes
- Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025
- Distribution
- Nationwide within the United States
- Quantity
- a) 6408 boxes and b)1488 boxes
- Recall started
- January 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0212-2025
-
Class I Ongoing
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.
Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Lots, distribution and details
- Lots / codes
- Lot# 0E3353D, Exp 03/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 14,340 100-count bottles
- Recall started
- December 23, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0211-2025
-
Class I Ongoing
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.
Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Lots, distribution and details
- Lots / codes
- Lot# 0R3092A, EXP 03/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 3,500 30-count bottles
- Recall started
- December 23, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0210-2025
-
Class III Terminated
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2
Reason: Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
Lots, distribution and details
- Lots / codes
- LOT# 091923A, Exp. Date 09/19/26
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 4,834 tins
- Recall started
- January 17, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0209-2025
-
Class III Completed
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Reason: Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Lots, distribution and details
- Lots / codes
- Lot #: 2402101UR, Exp 02/28/2027
- Distribution
- Nationwide USA.
- Quantity
- 1380 bottles
- Recall started
- January 16, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0208-2025
-
Class I Ongoing
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7
Reason: Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Lots, distribution and details
- Lots / codes
- Batch # 001, exp. date 09/10/2026
- Distribution
- Nationwide via internet sales
- Quantity
- 172 180-count bottles
- Recall started
- December 16, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0207-2025
-
Class II Ongoing
First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6
Reason: CGMP Deviations; product intended for quarantine was inadvertently distributed
Lots, distribution and details
- Lots / codes
- Lots 24D44, Exp 4/10/2026 & 24D45, 4/11/2026
- Distribution
- Nationwide
- Quantity
- 2756 jars
- Recall started
- December 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0206-2025
-
Class II Ongoing
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
Reason: CGMP Deviations: lack of adequate release testing.
Lots, distribution and details
- Lots / codes
- Lots: 23319025, 23318024, 23313023, 23311022, 23310021, 23222021, 23220020, 23215019, 23215018, 23214017, 23213016, 23208015, 2313014, 2312213, 2312212, 2312111, 2312110, 2311709, 2311708, 2311607, 2311506, 2311405, 2307904, 23073003, 23072002, 2306901 and 24135003. All expiration dates within expiry.
- Distribution
- Nationwide USA
- Quantity
- unknown
- Recall started
- November 13, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0205-2025
-
Class II Terminated
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
Reason: Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Lots, distribution and details
- Lots / codes
- Lot# 8182298, Exp 10/31/2025
- Distribution
- USA nationwide.
- Quantity
- 6,605/30 count bottles
- Recall started
- December 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0204-2025
-
Class II Terminated
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
Reason: Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Lots, distribution and details
- Lots / codes
- Lot # 8181625, Exp 12/31/2025
- Distribution
- USA nationwide.
- Quantity
- 1,215/30 count bottles
- Recall started
- December 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0203-2025
-
Class II Terminated
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3×10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
Reason: Failed Dissolution Specifications:
Lots, distribution and details
- Lots / codes
- Lot # 1012910, Exp Date: 04/30/2025
- Distribution
- Nationwide in the USA
- Quantity
- 2,028 units (cartons of 30 individual unit doses)
- Recall started
- December 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0202-2025
-
Class II Ongoing
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3×10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
Reason: Presence of Foreign Tablets/Capsules
Lots, distribution and details
- Lots / codes
- Lot #: 1018598, Exp. Date 10/31/2025
- Distribution
- Nationwide within the United States
- Quantity
- 4640 units
- Recall started
- January 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0201-2025
-
Class I Ongoing
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Reason: Non-Sterility
Lots, distribution and details
- Lots / codes
- Lot 10101; Exp.09/30/2025
- Distribution
- US Nationwide.
- Quantity
- 55,960 25-count boxes
- Recall started
- December 18, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0200-2025
-
Class III Ongoing
Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.
Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Lots, distribution and details
- Lots / codes
- Lot: KDC0224001B Exp 09/30/2026
- Distribution
- Nationwide in the US
- Quantity
- 324 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0199-2025
-
Class III Ongoing
Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.
Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Lots, distribution and details
- Lots / codes
- Lot: KDC0124002B Exp 09/30/2026
- Distribution
- Nationwide in the US
- Quantity
- 456 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0198-2025
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 3, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.