Class II · Posted November 4, 2026 · Started October 23, 2026 · Ongoing
electric medicated balm ultra strength
- Product
- ULTRA STRENTGH, ELECTRIC MIDICATED BALM (menthol 16% and methyl salicylate 32%) packaged in a) Net 2.45 oz (70g) (NDC 63299-001-01) and b) 10g (NDC 63299-001-02), Manufactured by Fei Fah Medical Mfg Pte Ltd, Singapore, U.S Distributor: SOLISTICE MEDICINE COMPANY, 215 West Ann Street, Los Angeles, CA 90012
- Firm
- Fei Fah Medical Manufacturing Pte. Ltd., Singapore, Singapore
- Reason
- CGMP Deviations
- Lots
- Lot: a)23FEBU7001-019, Exp. Date: October 2028; 24FEBU7001-020, Exp. Date: November 2029. b) 23FEBU1001-9, Exp. Date: October 2028; 24FEBU1001-004, Exp. Date: November 2029.
- Quantity
- 171,120 units
- Distribution
- Nationwide within the U.S
- RxNorm
- electric medicated balm ultra strength (RxCUI 2002730)
- Recall number
- D-0104-2027
Class II · Posted November 4, 2026 · Started October 21, 2026 · Ongoing
atorvastatin calcium
- Product
- Atorvastatin Calcium Tablets, USP, 40mg, 1000 tablets per bottle, Rx only, Manufactured by: MSL Laboratories Private Limited, Telangana - 509228, India; Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854-3714. NDC: 72205-024-99
- Firm
- MSN Laboratories Private Limited (Formulations Division, Unit-II), Rangareddy District, India
- Reason
- Presence of Foreign Tablets/Capsules
- Lots
- Lot: DRF09618A, Exp 08-31-2029, DRG02110A, Exp 01-31-2030.
- Quantity
- 13,296 1,000-count bottles
- Distribution
- Nationwide in the USA.
- RxNorm
- atorvastatin calcium (RxCUI 259255, 617310, 617311, 617312)
- Recall number
- D-0113-2027
Not yet classified · Posted November 4, 2026 · Started October 16, 2026 · Ongoing
lidocaine
- Product
- Tridacaine III / Lidocaine Patch 5%, 15 envelopes containing 1 patch each per pouch, Rx only, Distributed by: Trifluent Pharma San Antonio, TX 78213, NDC 73352-835-15.
- Firm
- Trifluent Pharma LLC, San Antonio, TX
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. Incorrect expiration date printed on the label.
- Lots
- Lot #: L2606225A, Exp. Date 06/22/2029.
- Quantity
- 68 pouches
- Distribution
- US
- RxNorm
- lidocaine (RxCUI 1745091, 2678310)
Class II · Posted November 4, 2026 · Started October 15, 2026 · Ongoing
formoterol fumarate dihydrate
- Product
- Formoterol Fumarate Inhalation Solution, 20mcg/2mL, packaged in cartons of 30 individually wrapped vials (NDC 76204-030-01) and 60 individually wrapped vials (NDC 76204-030-02), Rx only, Manufactured for and by: Ritedose Pharmaceuticals, LLC, Columbia, SC
- Firm
- The Ritedose Corporation, Columbia, SC
- Reason
- Failed Impurities/Degradation Specification
- Lots
- Lot: 25BL0, Expires: 02/28/2027
- Quantity
- 3210 Cartons
- Distribution
- Nationwide within the U.S
- RxNorm
- formoterol fumarate dihydrate (RxCUI 1246319)
- Recall number
- D-0073-2027
Class III · Posted November 4, 2026 · Started October 14, 2026 · Ongoing
ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg
- Product
- ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle, Distributed by:Prodose, Inc. Ronkonkoma, NY 11779, Made in India. UPC 8 50026 88900 0
- Firm
- Prodose, Inc., Ronkonkoma, NY
- Reason
- Incorrect label placed on product: Outer carton label correctly identifies drug product in bottle as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg,but inner label on bottle says ValuHealth Extra Strength Pain Relief PM
- Lots
- Lot #: P260252, Exp 4/30/2029
- Quantity
- 100,134 40-count bottles
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0081-2027
Class II · Posted November 4, 2026 · Started October 9, 2026 · Ongoing
abiraterone acetate
- Product
- Abiraterone Acetate Tablets USP 500 mg, 60-count bottles, Rx only, Distributed by: Glenmark Pharmaceuticals USA, Elmwood Park, NJ 07407, NDC 68462-882-60
- Firm
- Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ
- Reason
- Labeling: Not Elsewhere Classified
- Lots
- Lot #: 13250135, Exp. Date 11/2027
- Quantity
- 1296 bottles
- Distribution
- Nationwide within the United States
- RxNorm
- abiraterone acetate (RxCUI 1100075, 1918042)
- Recall number
- D-0074-2027
Class III · Posted November 4, 2026 · Started October 8, 2026 · Ongoing
vecuronium bromide
- Product
- Vecuronium Bromide for Injection, 20mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-745-21
- Firm
- Meitheal Pharmaceuticals, Inc, Chicago, IL
- Reason
- Labeling: Label Lacks Warning or Rx Legend
- Lots
- Lot# T1P0113C: Exp. 28-Feb-29 Lot# T1P0612C: Exp. 31-Oct-28
- Quantity
- 10,200 vials
- Distribution
- US. Nationwide
- RxNorm
- vecuronium bromide (RxCUI 859437)
- Recall number
- D-0109-2027
Class III · Posted November 4, 2026 · Started October 8, 2026 · Ongoing
vecuronium bromide
- Product
- Vecuronium Bromide for Injection, 10mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-744-11
- Firm
- Meitheal Pharmaceuticals, Inc, Chicago, IL
- Reason
- Labeling: Label Lacks Warning or Rx Legend
- Lots
- Lot# T1P0213A: Exp. 30-Apr-29 Lot# T1P0313A: Exp. 30-Apr-29 Lot# T1P0412A: Exp. 30-Sep-28 Lot# T1P0413A: Exp. 30-Apr-29 Lot# T1P0512A: Exp. 30-Sep-28 Lot# T1P0513A: Exp. 30-Apr-29
- Quantity
- 121,800 vials
- Distribution
- US. Nationwide
- RxNorm
- vecuronium bromide (RxCUI 859437)
- Recall number
- D-0108-2027
Class II · Posted November 4, 2026 · Started October 8, 2026 · Ongoing
OXYTOCIN
- Product
- OXYTOCIN, 30 USP UNITS, Added to 0.9% Sodium Chloride 500 mL - Single-Use Container, Rx Only, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Hoover, AL 35244, UPC: 6985203050. NDC 69852-030-50
- Firm
- Eagle Pharma Outsourcing LLC, Hoover, AL
- Reason
- Lack of Assurance of Sterility
- Lots
- Lot: OXY30-1006, Expiry: 10/10/2026.
- Quantity
- 5 500-mL containers
- Distribution
- Nationwide within the U.S
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0106-2027
Class II · Posted November 4, 2026 · Started October 8, 2026 · Ongoing
PHENYLephrine HCL Infusion
- Product
- PHENYLephrine HCL Infusion, 100 mg per 250 mL in 0.9% Sodium Chloride (0.4 mg/mL), Sterile, Rx Only, Single-Use Container, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Hoover, AL 35244, UPC: 6985210025. NDC 69852-100-25
- Firm
- Eagle Pharma Outsourcing LLC, Hoover, AL
- Reason
- Lack of Assurance of Sterility
- Lots
- Lot: PHENYL100-1004, Expiry: 12/31/2026.
- Quantity
- 50 250 mL-containers
- Distribution
- Nationwide within the U.S
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0105-2027
Class II · Posted November 4, 2026 · Started October 7, 2026 · Ongoing
olmesartan medoxomil amlodipine and hydrochlorothiazide
- Product
- Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5mg, packaged as a) 30-count bottle, NDC 33342-246-07; b) 90-count bottle, NDC 33342-246-10; Rx Only, Manufactured for : Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd, Daman, 396210, India
- Firm
- MACLEODS PHARMA USA, INC, Princeton, NJ
- Reason
- Failed Dissolution Specifications.
- Lots
- Lot #: a) 12251163A, Exp 05-31-2027; b) 12251163B, Exp 05-31-2027
- Quantity
- 3528 30-count and 216 90-count bottles
- Distribution
- Nationwide in the USA
- RxNorm
- olmesartan medoxomil amlodipine and hydrochlorothiazide (RxCUI 999967, 999986, 999991, 999996, 1000001)
- Recall number
- D-0077-2027
Class II · Posted November 4, 2026 · Started October 6, 2026 · Ongoing
Theophylline Extended-Release Tablets
- Product
- Theophylline Extended-Release Tablets, 200 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-501-10.
- Firm
- Brandywine Pharmaceuticals, LLC, West Chester, PA
- Reason
- CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
- Lots
- Lot: 405620, Expiry: 03/31/2028.
- Quantity
- 1,332 100-count bottles
- Distribution
- Nationwide within U.S
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0111-2027
Class II · Posted November 4, 2026 · Started October 6, 2026 · Ongoing
Theophylline Extended-Release Tablets
- Product
- Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-500-10
- Firm
- Brandywine Pharmaceuticals, LLC, West Chester, PA
- Reason
- CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
- Lots
- Lot: 405617, Expiry: 03/31/2028
- Quantity
- 1,620 100-count bottles
- Distribution
- Nationwide within U.S
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0110-2027
Class II · Posted November 4, 2026 · Started October 6, 2026 · Ongoing
metoclopramide
- Product
- Metoclopramide Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 51079-886-20.
- Firm
- Safecor Health, LLC, Rockford, IL
- Reason
- Manufacturer is recalling batches due to co-mingled tablet.
- Lots
- Lot # 3116509, Expiry: 07/31/2027.
- Distribution
- US Nationwide
- RxNorm
- metoclopramide (RxCUI 311666, 311668)
- Recall number
- D-0075-2027
Class II · Posted November 4, 2026 · Started October 2, 2026 · Ongoing
Carboxymethylcellulose Sodium
- Product
- Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops, Sterile, 30 Single-Use Containers, 0.02 FL OZ (0.5 mL) each, Manufactured by: Huons Co., Ltd, Jecheon-si, Chungcheongbuk-do, 27159, South Korea; Marketed by: GSMS Incorporated, Camarillo, CA 93012, USA. NDC 51407-945-30 Pouch Label: Carboxymethylcellulose Sodium, Lubricant Eye Drops, 0.5 mL, Single-Use, gsms.
- Firm
- Huons Co., Ltd., Jecheon, Korea (the Republic of)
- Reason
- Failed Impurities/Degradation Specification; detection of polyethylene (PE)-related oligomers
- Lots
- Lot: 2EQH501, Exp. 3/12/2027; 2EQH502, 2EQH503, 2EQH504, 2EQH505, Exp. 3/16/2027; 2EQH506, 2EQH507, Exp. 5/22/2027; 2EQH508, Exp. 5/26/2027; 2EQH509, Exp. 5/27/2027; 2EQH510, 2EQH511, 2EQH512, 2EQH513, Exp. 10/13/2028.
- Quantity
- 6,633,570 tubes
- Distribution
- Nationwide within U.S.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0080-2027
Class II · Posted November 4, 2026 · Started September 29, 2026 · Ongoing
Lidocaine Ointment USP
- Product
- Lidocaine Ointment USP, 5.0 % 50g JAR, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534, NDC 72189-0211-50
- Firm
- Direct Rx, Dawsonville, GA
- Reason
- Subpotent Drug
- Lots
- LOT#: 03AP2511, 30AP2518, 18JU2519, 18JU2520, Exp. Date 04/30/2027.
- Quantity
- 493 jars
- Distribution
- Nationwide within the United States
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0107-2027
Class II · Posted November 4, 2026 · Started September 22, 2026 · Ongoing
Wechem Hand Guard8/1000mL Bag
- Product
- Wechem Hand Guard8/1000mL Bag, Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA, 30013
- Firm
- ABC Compounding Co., Inc., Conyers, GA
- Reason
- CGMP Deviations
- Lots
- 5800 bottles
- Quantity
- 5800 bottles
- Distribution
- US Nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0103-2027
Class II · Posted November 4, 2026 · Started September 22, 2026 · Ongoing
SunCoast Paper Inc. Surgent Antiseptic Hand Soap
- Product
- SunCoast Paper Inc. Surgent Antiseptic Hand Soap, Net Contents : 1 Gallon (3.8 L), SunCoast Paper In., 4111 Community Rd., Brunswick, GA 31520, UPC 654441P10219
- Firm
- ABC Compounding Co., Inc., Conyers, GA
- Reason
- CGMP Deviations
- Lots
- 2256 bottles
- Quantity
- 576 bottles
- Distribution
- US Nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0102-2027
Class II · Posted November 4, 2026 · Started September 22, 2026 · Ongoing
Spurrier
- Product
- Spurrier, Antimicrobial Hand Soap, Net Contents: 1 Gallon (3.8 L), Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA, 30013, UPC 726133100508
- Firm
- ABC Compounding Co., Inc., Conyers, GA
- Reason
- CGMP Deviations
- Lots
- 15 bottles
- Quantity
- 15 bottles
- Distribution
- US Nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0101-2027
Class II · Posted November 4, 2026 · Started September 22, 2026 · Ongoing
Chemseptic
- Product
- Chemseptic, Net Contents: 1 Gallon (3.8 L), Distributed By: RMC Rochester Midland Corporation, 155 Paragon Drive, Rochester, NY 14624 USA, Made in USA
- Firm
- ABC Compounding Co., Inc., Conyers, GA
- Reason
- CGMP Deviations
- Lots
- 2316 bottles
- Quantity
- 3120 bottles
- Distribution
- US Nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0100-2027
Class II · Posted November 4, 2026 · Started September 22, 2026 · Ongoing
Pro Chem Suds Hand Soap
- Product
- Pro Chem Suds Hand Soap, Net Contents: 18 OZ (532 ml), Sold by Pro Chem Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004
- Firm
- ABC Compounding Co., Inc., Conyers, GA
- Reason
- CGMP Deviations
- Lots
- 576 bottles
- Quantity
- 5760 bottles
- Distribution
- US Nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0099-2027
Class II · Posted November 4, 2026 · Started September 22, 2026 · Ongoing
PRO CHEM BAN AID
- Product
- PRO CHEM BAN AID, Antiseptic Hand Soap, Net Contents: 1 GALLON (3.8 L), Sold by: PRO CHEM, Inc.,1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004.
- Firm
- ABC Compounding Co., Inc., Conyers, GA
- Reason
- CGMP Deviations
- Lots
- 288 bottles
- Quantity
- 288 bottles
- Distribution
- US Nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0098-2027
Class II · Posted November 4, 2026 · Started September 22, 2026 · Ongoing
PRO CHEM Fresh Start
- Product
- PRO CHEM Fresh Start, Antibacterial Hand Soap, Antiseptic Hand Soap, 800mL bag, Sold by: PRO CHEM, Inc.,1475 Bluegrass Lakes Parkway, Alpharetta, GA 30064.
- Firm
- ABC Compounding Co., Inc., Conyers, GA
- Reason
- CGMP Deviations
- Lots
- 1944 bottles
- Quantity
- 1944 bottles
- Distribution
- US Nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0097-2027
Class II · Posted November 4, 2026 · Started September 22, 2026 · Ongoing
People's FM-24 FOAMING High Foaming Antiseptic Hand and Body Wash
- Product
- People's FM-24 FOAMING High Foaming Antiseptic Hand and Body Wash, NET CONTENTS: 1000 ML 33.8 FL OZ, Distributed by: People's Janitorial Supply, 955 Main Street, Forest Park, GA 30298, 404-363-2226.
- Firm
- ABC Compounding Co., Inc., Conyers, GA
- Reason
- CGMP Deviations
- Lots
- 600 bottles
- Quantity
- 78840 bottles
- Distribution
- US Nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0096-2027
Class II · Posted November 4, 2026 · Started September 22, 2026 · Ongoing
Handtastic Foamy Mango Antiseptic Foam Soap Hand & Body Wash
- Product
- Handtastic Foamy Mango Antiseptic Foam Soap Hand & Body Wash, Net Contents : 18oz (532ml), Sold by, Momar Incorporated, 1880 Ellsworth Industrial Drive, N.W., Atlanta, Georgia, 80818.
- Firm
- ABC Compounding Co., Inc., Conyers, GA
- Reason
- CGMP Deviations
- Lots
- 1440 bottles
- Quantity
- 10908 bottles
- Distribution
- US Nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0095-2027