Class II · Posted March 11, 2026 · Started March 3, 2026 · Ongoing
temozolomide
- Product
- Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
- Firm
- Rising Pharma Holding, Inc., East Brunswick, NJ
- Reason
- Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
- Lots
- Lot #: 1TM0524003A, Exp. Date 09/2026.
- Quantity
- 1200 bottles
- Distribution
- Nationwide within the U.S
- RxNorm
- temozolomide (RxCUI 313209, 313210, 313211, 317160, 700883, +1 more)
- Recall number
- D-0384-2026
Class II · Posted March 11, 2026 · Started February 26, 2026 · Ongoing
Tirzepatide Inj
- Product
- Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
- Firm
- New Life Pharma LLC, Northvale, NJ
- Reason
- Lack of Assurance of Sterility
- Lots
- Lot 240709, exp 7/31/2026
- Quantity
- 45 vials
- Distribution
- OH
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0395-2026
Class II · Posted March 11, 2026 · Started February 26, 2026 · Ongoing
Tirzepatide Inj
- Product
- Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
- Firm
- New Life Pharma LLC, Northvale, NJ
- Reason
- Lack of Assurance of Sterility
- Lots
- Lot 240709, exp 7/31/2026
- Quantity
- 23 vials
- Distribution
- OH
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0394-2026
Class II · Posted March 11, 2026 · Started February 26, 2026 · Ongoing
Semaglutide Inj.
- Product
- Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06
- Firm
- New Life Pharma LLC, Northvale, NJ
- Reason
- Lack of Assurance of Sterility
- Lots
- Lot 240903, exp 9/30/2026
- Quantity
- 2 vials
- Distribution
- OH
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0393-2026
Class II · Posted March 11, 2026 · Started February 26, 2026 · Ongoing
Semaglutide Inj
- Product
- Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.
- Firm
- New Life Pharma LLC, Northvale, NJ
- Reason
- Lack of Assurance of Sterility
- Lots
- Lot 241113, Exp Date 11/30/2026 & Lot 250103, Exp Date 1/31/2027
- Quantity
- 820 vials
- Distribution
- OH
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0392-2026
Class II · Posted March 11, 2026 · Started February 24, 2026 · Ongoing
isotretinoin
- Product
- Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
- Firm
- MYLAN PHARMACEUTICALS INC, Morgantown, WV
- Reason
- Failed Dissolution Specifications
- Lots
- Lot #: 3116110, 3116130, Exp. Date 07/2026
- Quantity
- 34850 blister packs
- Distribution
- Nationwide within the United States
- RxNorm
- isotretinoin (RxCUI 197843, 197844, 197845, 403930, 404058, +3 more)
- Recall number
- D-0399-2026
Class II · Posted March 11, 2026 · Started February 18, 2026 · Ongoing
MAXIMUM
- Product
- MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.
- Firm
- HTO Nevada Inc. dba Kirkman, Lake Oswego, OR
- Reason
- Stability Data Does Not Support Expiry Date.
- Lots
- Lot #: 795CP-0005, Exp. Date 06/30/2026
- Quantity
- 243 bottles
- Distribution
- Nationwide within the U.S
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0387-2026
Class II · Posted March 11, 2026 · Started February 18, 2026 · Ongoing
MAXIMUM
- Product
- MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
- Firm
- HTO Nevada Inc. dba Kirkman, Lake Oswego, OR
- Reason
- Stability Data Does Not Support Expiry Date.
- Lots
- Lot #: 807CP-0003, Exp. Date 07/31/2026.
- Quantity
- 178 bottles
- Distribution
- Nationwide within the U.S
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0386-2026
Class II · Posted March 11, 2026 · Started February 18, 2026 · Ongoing
FIVE-STAR
- Product
- FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
- Firm
- HTO Nevada Inc. dba Kirkman, Lake Oswego, OR
- Reason
- Stability Data Does Not Support Expiry Date.
- Lots
- Lot #: 839CP-0016, Exp. Date 03/31/2026; 839CP-0017, Exp. Date 06/30/2026; 839CP-0018, Exp. Date 08/31/2026; 839CP-0019, Exp. Date 10/31/2026; 839CP-0020, Exp. Date 03/31/2027; 839CP-0021, Exp. Date 07/31/2027; 839CP-0022, Exp.Date 11/30/2027; 839CP-0023, Exp. Date 02/29/2028; 839CP-0024, Exp. Date 07/31/2028.
- Quantity
- 27,380 bottles.
- Distribution
- Nationwide within the U.S
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0385-2026
Class III · Posted March 11, 2026 · Started February 18, 2026 · Ongoing
Nilotinib Capsules
- Product
- Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17
- Firm
- Cipla USA, Inc., Warren, NJ
- Reason
- Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- Lots
- Lot #: 5GJ0223, Exp 04/30/2027
- Quantity
- 164 cartons
- Distribution
- U.S.A. Nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0382-2026
Class III · Posted March 11, 2026 · Started February 18, 2026 · Ongoing
Nilotinib Capsules
- Product
- Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
- Firm
- Cipla USA, Inc., Warren, NJ
- Reason
- Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- Lots
- Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
- Quantity
- 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
- Distribution
- U.S.A. Nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0381-2026
Class II · Posted March 11, 2026 · Started February 17, 2026 · Ongoing
midodrine hydrochloride
- Product
- Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.
- Firm
- The Harvard Drug Group LLC, Dublin, OH
- Reason
- Defective container; inadequately sealed blister packaging.
- Lots
- Lot # N02640, Exp Date: 08/2027
- Quantity
- 8892 cartons
- Distribution
- Nationwide US.
- RxNorm
- midodrine hydrochloride (RxCUI 993462, 993466, 993470)
- Recall number
- D-0383-2026
Class II · Posted March 11, 2026 · Started February 13, 2026 · Ongoing
Semaglutide
- Product
- Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.
- Firm
- Harbin Jixianglong Biotech Co., Ltd., Haerbin, China
- Reason
- CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
- Lots
- Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.
- Distribution
- Nationwide within the United States
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0380-2026
Class II · Posted March 11, 2026 · Started February 13, 2026 · Ongoing
Semaglutide
- Product
- Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China
- Firm
- Harbin Jixianglong Biotech Co., Ltd., Haerbin, China
- Reason
- CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
- Lots
- Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027
- Distribution
- Nationwide within the United States
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0379-2026
Class II · Posted March 11, 2026 · Started January 29, 2026 · Ongoing
metoprolol succinate
- Product
- Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11
- Firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Reason
- Failed Dissolution Specifications
- Lots
- Lot#: a) 0686H251, 0687H251, 10688H251, Exp.: 02/2027. .
- Quantity
- 19,056 bottles
- Distribution
- Nationwide
- RxNorm
- metoprolol succinate (RxCUI 866412, 866419, 866427, 866436)
- Recall number
- D-0357-2026
Class II · Posted March 11, 2026 · Started January 29, 2026 · Ongoing
metoprolol succinate
- Product
- Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.
- Firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Reason
- Failed Dissolution Specifications
- Lots
- Lot#: a) 0718J251, 0729J251, 0730J251, Exp.: 12/2026; b) 0718J252, 0729J252, 0730J252, Exp.: 12/2026.
- Quantity
- 7,448 bottles
- Distribution
- Nationwide
- RxNorm
- metoprolol succinate (RxCUI 866412, 866419, 866427, 866436)
- Recall number
- D-0356-2026
Class II · Posted March 11, 2026 · Started January 29, 2026 · Ongoing
metoprolol succinate
- Product
- Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
- Firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Reason
- Failed Dissolution Specifications
- Lots
- Lot#: a) 0486G251, 0487G251, 0488G251, Exp.: 01/2027; b) 0486G252, 0487G253, 0488G252, Exp.: 01/2027.
- Quantity
- 67,043 bottles
- Distribution
- Nationwide
- RxNorm
- metoprolol succinate (RxCUI 866412, 866419, 866427, 866436)
- Recall number
- D-0355-2026
Class II · Posted March 11, 2026 · Started January 29, 2026 · Ongoing
metoprolol succinate
- Product
- Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
- Firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Reason
- Failed Dissolution Specifications
- Lots
- Lot#: a) 0715J251, Exp.: 12/2026; 0716J251, Exp.: 01/2027; 0717J251, Exp.: 01/2027; b) 0715J252, Exp.: 12/2026; 0716J252, Exp.: 01/2027, 0717J252, Exp.: 01/2027.
- Quantity
- 18,780 bottles
- Distribution
- Nationwide
- RxNorm
- metoprolol succinate (RxCUI 866412, 866419, 866427, 866436)
- Recall number
- D-0354-2026
Class II · Posted March 11, 2026 · Started January 26, 2026 · Ongoing
sodium iodide i-131
- Product
- Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
- Firm
- Radnostix, Idaho Falls, ID
- Reason
- Presence of Particulate Matter: Due to production issues
- Lots
- Batch I012626R-01, Exp 02/09/2026
- Quantity
- 16 units
- Distribution
- Nationwide in the USA and Puerto Rico
- RxNorm
- sodium iodide i-131
- Recall number
- D-0389-2026
Class II · Posted March 11, 2026 · Started January 20, 2026 · Ongoing
Antimicrobial Alcohol Hand Wipe
- Product
- Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.
- Firm
- ACME UNITED CORPORATION, Shelton, CT
- Reason
- CGMP Deviations
- Lots
- Lot #: MN15423 , MN16422, Exp. Date Apr 2027-Apr; MN26322, MN26322, Exp. Date Aug 2027; MN03423, MN03423, Exp. Date Jan 2028; MN09722, Exp. Date Mar 2027; MN31722, Exp. Date Oct 2027; MN15722, MN13722 Exp. Date Apr 2027; MN31722, Exp. Date Oct 2027; MN09722, Exp. Date Mar 2027.
- Distribution
- Nationwide within the United States
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0378-2026
Class II · Posted March 11, 2026 · Started January 20, 2026 · Ongoing
Children's Healthcare of Atlanta
- Product
- Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00
- Firm
- ACME UNITED CORPORATION, Shelton, CT
- Reason
- CGMP Deviations
- Lots
- Lot #: MN12122, Exp. Date Apr 2027; MN27523, Exp. Date Aug 2028; MN30922, Exp. Date Oct 2027.
- Distribution
- Nationwide within the United States
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0377-2026
Class II · Posted March 11, 2026 · Started January 20, 2026 · Ongoing
benzalkonium chloride
- Product
- Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.
- Firm
- ACME UNITED CORPORATION, Shelton, CT
- Reason
- CGMP Deviations
- Lots
- Lot #: 53518, 53519, Exp. Date Jun 2027.
- Distribution
- Nationwide within the United States
- RxNorm
- benzalkonium chloride (RxCUI 1038558)
- Recall number
- D-0376-2026
Class II · Posted March 11, 2026 · Started January 20, 2026 · Ongoing
benzalkonium chloride
- Product
- Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01
- Firm
- ACME UNITED CORPORATION, Shelton, CT
- Reason
- CGMP Deviations
- Lots
- Lot #: 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352, Exp. Date Mar 2027; 53518, Exp. Date Jun 2027.
- Distribution
- Nationwide within the United States
- RxNorm
- benzalkonium chloride (RxCUI 1038558)
- Recall number
- D-0375-2026
Class II · Posted March 11, 2026 · Started January 20, 2026 · Ongoing
benzalkonium chloride
- Product
- Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73
- Firm
- ACME UNITED CORPORATION, Shelton, CT
- Reason
- CGMP Deviations
- Lots
- Lot #: MN15922, Exp. Date Apr 2027; MN18223, Exp. Date May 2028; MN10123, Exp. Date Mar 2028; MN27223, Exp. Date Aug 2028; MN01023, Exp. Date Dec 2027.
- Distribution
- Nationwide within the United States
- RxNorm
- benzalkonium chloride (RxCUI 1038558)
- Recall number
- D-0374-2026
Class II · Posted March 11, 2026 · Started January 20, 2026 · Ongoing
isopropyl alcohol
- Product
- Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00
- Firm
- ACME UNITED CORPORATION, Shelton, CT
- Reason
- CGMP Deviations
- Lots
- Lot #: MN24922, Exp. Date Aug 2027; MN31122, Exp. Date Oct 2027.
- Distribution
- Nationwide within the United States
- RxNorm
- isopropyl alcohol (RxCUI 797544)
- Recall number
- D-0373-2026