Drug Recalls

CHLORPROMAZINE HYDROCHLORIDE

Wed Apr 23 2025

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2

Wed Apr 23 2025

CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

Wed Apr 23 2025

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

LEVETIRACETAM (LEVETIRACETAM INJECTION)

Wed Apr 23 2025

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

TESTOSTERONE CYPIONATE

Wed Apr 23 2025

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

SODIUM CHLORIDE

Wed Apr 16 2025

Presence of Particulate Matter

VENLAFAXINE

Wed Apr 16 2025

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

SOFOSBUVIR AND VELPATASVIR (VELPATASVIR AND SOFOSBUVIR)

Wed Apr 16 2025

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

CHLORPROMAZINE HYDROCHLORIDE

Wed Apr 16 2025

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Multiple Drug Recalls - Glenmark Pharmaceuticals Inc., USA

Wed Apr 16 2025

CGMP Deviations

GABAPENTIN

Wed Apr 16 2025

Cross Contamination

Multiple Drug Recalls - Somerset Therapeutics Private Limited

Wed Apr 16 2025

Lack of Assurance of Sterility: Media fill with bacterial contamination

Multiple Drug Recalls - Alchemee, LLC

Wed Apr 16 2025

Chemical contamination: Presence of benzene

CHLORPROMAZINE HYDROCHLORIDE

Wed Apr 09 2025

CGMP deviations: Results of the finished product is above the Agency's current recommended limit of a nitrosamine, N-Nitroso-Desmethyl Chlorpromazine impurity.

VORICONAZOLE

Wed Apr 09 2025

cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.

TOLTERODINE TARTRATE (TOLTERODINE)

Wed Apr 09 2025

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Apr 09 2025

CGMP Deviations: Due to the presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.

Wed Apr 09 2025

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.

ATORVASTATIN CALCIUM

Wed Apr 09 2025

Failed dissolution specifications: lower than specifications

babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.

Wed Apr 02 2025

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

TESTOSTERONE

Wed Apr 02 2025

Presence of foreign substance: Presence of Benzene.

SODIUM BICARBONATE

Wed Apr 02 2025

Lack of Assurance of Sterility

Multiple Drug Recalls - Ascent Consumer Products Inc.

Wed Apr 02 2025

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

HYDROGEN PEROXIDE

Wed Apr 02 2025

Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol

METFORMIN HYDROCHLORIDE

Wed Apr 02 2025

Presence of Foreign Tablets/Capsules.

Multiple Drug Recalls - QuVa Pharma, Inc.

Wed Apr 02 2025

Lack of Assurance of Sterility

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Mar 26 2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

PRASUGREL

Wed Mar 26 2025

Failed Dissolution Specifications - low dissolution results

CIPROFLOXACIN

Wed Mar 26 2025

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

CINACALCET HYDROCHLORIDE

Wed Mar 26 2025

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Multiple Drug Recalls - MEDLINE INDUSTRIES, LP - Northfield

Wed Mar 26 2025

Subpotent Drug

Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.

Wed Mar 26 2025

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.

LEVOTHYROXINE SODIUM

Wed Mar 26 2025

Super-Potent Drug: Out of specification potency results were obtained.

NEUPOGEN (FILGRASTIM)

Wed Mar 26 2025

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

Multiple Drug Recalls - Fruit Of The Earth, Inc.

Wed Mar 26 2025

Chemical contamination: presence of benzene

PRASUGREL

Wed Mar 26 2025

Failed Dissolution Specifications

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Mar 19 2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50

Wed Mar 19 2025

Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.

LIVALO (PITAVASTATIN CALCIUM)

Wed Mar 19 2025

Presence of foreign tablets/capsules

PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1.

Wed Mar 19 2025

Presence of Particulate Matter

ZAPZYT ACNE TREATMENT GEL (BENZOYL PEROXIDE)

Wed Mar 19 2025

Chemical Contamination: Presence of benzene.

CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)

Wed Mar 19 2025

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

POTASSIUM CHLORIDE

Wed Mar 19 2025

Multiple recall reasons - tap to see more information.

Multiple Drug Recalls - Aspen Biopharma Labs Pvt., Ltd.

Wed Mar 19 2025

CGMP violations

Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8

Wed Mar 19 2025

Chemical Contamination: Presence of benzene

Multiple Drug Recalls - Johnson, S C and Son, Inc

Wed Mar 19 2025

Chemical Contamination

Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0

Wed Mar 19 2025

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

MORPHINE SULFATE

Wed Mar 12 2025

Failed Dissolution Specifications

Multiple Drug Recalls - Safecor Health, LLC

Wed Mar 12 2025

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

NELARABINE

Wed Mar 12 2025

Failed Impurities/Degradation Specifications