Drug recalls, 2025-W52

FDA drug recalls, December 22 to 28, 2025

FDA posted 13 drug recalls the week of December 22, 2025: 10 Class II and 3 Class III. Novocol Pharmaceutical of Canada, Inc. has the most, with 7.

License: openFDA publishes this file under CC0 1.0.

FDA sorts recalls by risk. Class I: using the product could cause serious health problems or death. Class II: it could cause temporary or reversible health problems. Class III: it is unlikely to cause health problems.

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Recalls posted December 22 to 28, 2025

Class II · Posted December 24, 2025 · Started December 9, 2025 · Ongoing

Ciclopirox Shampoo

Product
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
Firm
SUN PHARMA /TARO, Hawthorne, NY
Reason
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Lots
Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
Quantity
17,664 units
Distribution
Nationwide within the United States
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0240-2026

Class III · Posted December 24, 2025 · Started November 26, 2025 · Ongoing

cisatracurium besylate

Product
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.
Firm
SOMERSET THERAPEUTICS LLC, Somerset, NJ
Reason
Subpotent product:out of specification assay results observed during long term stability testing.
Lots
Lot#: A250043, EXP Date 06/30/2026
Quantity
71,310 10mL vials
Distribution
Nationwide in the USA
RxNorm
cisatracurium besylate (RxCUI 199211)
Recall number
D-0238-2026

Class III · Posted December 24, 2025 · Started November 26, 2025 · Ongoing

cisatracurium besylate

Product
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.
Firm
SOMERSET THERAPEUTICS LLC, Somerset, NJ
Reason
Subpotent product:out of specification assay results observed during long term stability testing.
Lots
Lot #: A250020, Exp Date 06/30/2026
Quantity
28,660 20mL vials
Distribution
Nationwide in the USA
RxNorm
cisatracurium besylate (RxCUI 199212, 1730194)
Recall number
D-0237-2026

Class III · Posted December 24, 2025 · Started November 26, 2025 · Ongoing

cisatracurium besylate

Product
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.
Firm
SOMERSET THERAPEUTICS LLC, Somerset, NJ
Reason
Subpotent product:out of specification assay results observed during long term stability testing.
Lots
Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
Quantity
52,340 5mL vials
Distribution
Nationwide in the USA
RxNorm
cisatracurium besylate (RxCUI 199212, 1730194)
Recall number
D-0236-2026

Class II · Posted December 24, 2025 · Started November 26, 2025 · Ongoing

baclofen

Product
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10
Firm
Golden State Medical Supply Inc., Camarillo, CA
Reason
Presence of Foreign Tablets/Capsules
Lots
Lot GS065762
Quantity
2472 HDPE Bottles
Distribution
Nationwide within the USA
RxNorm
baclofen (RxCUI 197391, 197392, 430902)
Recall number
D-0235-2026

Class II · Posted December 24, 2025 · Started November 17, 2025 · Ongoing

Ondansetron ODT Tablets

Product
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
Firm
Preferred Pharmaceuticals, Inc., Anaheim, CA
Reason
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Lots
Lot: J1325J, I1725P, EXP Date: 4/30/2027.
Quantity
575 1x10 Foil Blister Packs
Distribution
Natinowide in the USA
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0239-2026

Class II · Posted December 24, 2025 · Started October 31, 2025 · Ongoing

phentolamine mesylate

Product
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10
Firm
Novocol Pharmaceutical of Canada, Inc., Cambridge, Canada
Reason
Defective container: cracked/broken cartridges
Lots
Lot: D05004E, expires: 04-30-2027
Quantity
1,636 cartons
Distribution
U.S.A. Nationwide
RxNorm
phentolamine mesylate (RxCUI 1361019, 1361021)
Recall number
D-0234-2026

Class II · Posted December 24, 2025 · Started October 31, 2025 · Ongoing

mepivacaine hydrochloride

Product
Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05.
Firm
Novocol Pharmaceutical of Canada, Inc., Cambridge, Canada
Reason
Defective container: cracked/broken cartridges
Lots
Lot: D05159I, expires: 07-31-2027
Quantity
40 cartons
Distribution
U.S.A. Nationwide
RxNorm
mepivacaine hydrochloride (RxCUI 1012745, 1305263)
Recall number
D-0233-2026

Class II · Posted December 24, 2025 · Started October 31, 2025 · Ongoing

mepivacaine hydrochloride

Product
Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.
Firm
Novocol Pharmaceutical of Canada, Inc., Cambridge, Canada
Reason
Defective container: cracked/broken cartridges
Lots
Lot: D05159H, expires: 07-31-2027
Distribution
U.S.A. Nationwide
RxNorm
mepivacaine hydrochloride (RxCUI 1305263)
Recall number
D-0232-2026

Class II · Posted December 24, 2025 · Started October 31, 2025 · Ongoing

mepivacaine hydrochloride

Product
darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.
Firm
Novocol Pharmaceutical of Canada, Inc., Cambridge, Canada
Reason
Defective container: cracked/broken cartridges
Lots
Lot: D05159G, expires: 07-31-2027
Quantity
5,520 Cartons
Distribution
U.S.A. Nationwide
RxNorm
mepivacaine hydrochloride (RxCUI 1305263)
Recall number
D-0231-2026

Class II · Posted December 24, 2025 · Started October 31, 2025 · Ongoing

mepivacaine hydrochloride

Product
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.
Firm
Novocol Pharmaceutical of Canada, Inc., Cambridge, Canada
Reason
Defective container: cracked/broken cartridges
Lots
Lot: D05159C, expires: 07-31-2027
Quantity
5,825
Distribution
U.S.A. Nationwide
RxNorm
mepivacaine hydrochloride (RxCUI 1012756, 1305263)
Recall number
D-0230-2026

Class II · Posted December 24, 2025 · Started October 31, 2025 · Ongoing

lidocaine hydrochloride and epinephrine bitartrate

Product
Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.
Firm
Novocol Pharmaceutical of Canada, Inc., Cambridge, Canada
Reason
Defective container: cracked/broken cartridges
Lots
Lot: D05362A, expires: 07-31-2027
Quantity
12,033 cartons
Distribution
U.S.A. Nationwide
RxNorm
lidocaine hydrochloride and epinephrine bitartrate (RxCUI 1293648)
Recall number
D-0229-2026

Class II · Posted December 24, 2025 · Started October 31, 2025 · Ongoing

lidocaine hydrochloride and epinephrine bitartrate

Product
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.
Firm
Novocol Pharmaceutical of Canada, Inc., Cambridge, Canada
Reason
Defective container: cracked/broken cartridges
Lots
Lot: D05337B, expires: 06-30-2027
Quantity
18,789 cartons- 50 cartridges /carton
Distribution
U.S.A. Nationwide
RxNorm
lidocaine hydrochloride and epinephrine bitartrate (RxCUI 1010768, 1293648, 1608499, 1657026)
Recall number
D-0228-2026

Source: openFDA drug enforcement reports, as of October 14, 2026. Publisher page

About this data

Each row is one FDA drug enforcement report: one product from one firm. A week here is Monday to Sunday, keyed on the date FDA listed the recall in its weekly Enforcement Report. The date the firm started the recall is shown on each row and is often weeks earlier.

Class I means use of the product could cause serious health problems or death. Class II means it could cause temporary or reversible health problems. Class III means it is unlikely to cause health problems. RxNorm names and RxCUIs come from openFDA's match of the product to its drug label. Compounded products often have no match.

This page lists public records. It is not medical advice. Check the FDA record before acting on a recall.

Source: openFDA drug enforcement reports, as of October 14, 2026. Publisher page

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FDA drug recalls, December 22 to 28, 2025: 13 recalls