DrugDec 16, 2020
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only recall — FDA D-0122-2021
CGMP Deviations
Class IIFDA: TerminatedShilpa Medicare Limited
10,685drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 130
10,685 detailed records are currently available in this category.
DrugDec 16, 2020
Scandonest 3% Plain recall — FDA D-0127-2021
Labeling: Label mix-up
Class IIIFDA: TerminatedNovocol Pharmaceutical of Canada, Inc.
DrugDec 16, 2020
Shilpa Medicare Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only recall — FDA D-0126-2021
CGMP Deviations
Class IIFDA: TerminatedShilpa Medicare Limited
DrugDec 16, 2020
Shilpa Medicare Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only recall — FDA D-0121-2021
CGMP Deviations
Class IIFDA: TerminatedShilpa Medicare Limited
DrugDec 16, 2020
Fresenius Kabi USA Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL recall — FDA D-0120-2021
Cross Contamination with other products: trace amounts of lidocaine
Class IFDA: TerminatedFresenius Kabi USA, LLC
DrugDec 16, 2020
Asiaticon, SA de CV Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70% recall — FDA D-0117-2021
Lack of CGMPs:
Class IIFDA: TerminatedAsiaticon, SA de CV
DrugDec 9, 2020
Golden State Medical Supply ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles recall — FDA D-0112-2021
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Class IIFDA: TerminatedGolden State Medical Supply Inc.
DrugDec 9, 2020
US Pharmaceuticals CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g) recall — FDA D-0113-2021
Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
Class IIFDA: TerminatedUS Pharmaceuticals Inc.
DrugDec 9, 2020
The Harvard Drug Group Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton recall — FDA D-0114-2021
Failed Dissolution Specifications: Out of specification for dissolution.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugDec 9, 2020
Lohxa Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free recall — FDA D-0111-2021
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
Class IFDA: TerminatedLohxa LLC
DrugDec 9, 2020
InvaTech Pharma Solutions Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle recall — FDA D-0115-2021
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Class IIIFDA: TerminatedInvaTech Pharma Solutions, LLC
DrugDec 9, 2020
REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g) recall — FDA D-0118-2021
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Class IFDA: TerminatedMPM Medical LLC
DrugDec 2, 2020
DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL recall — FDA D-0105-2021
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Class IIIFDA: TerminatedFresenius Kabi USA, LLC
DrugDec 2, 2020
AA PRODUCTS SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ recall — FDA D-0102-2021
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class IIFDA: CompletedAA PRODUCTS Inc.
DrugDec 2, 2020
Fusion Health and Vitality Immune Boost with natural strawberry flavor, 8,000 IU, Supports a recall — FDA D-0107-2021
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Class IIFDA: TerminatedFusion Health and Vitality LLC
DrugDec 2, 2020
EYWA PHARMA Levetiracetam Tablets, USP 500 mg recall — FDA D-0109-2021
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Class IIFDA: TerminatedEYWA PHARMA Inc.
DrugDec 2, 2020
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle recall — FDA D-0108-2021
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Class IIIFDA: TerminatedHeritage Pharmaceuticals Inc.
DrugDec 2, 2020
Sunstar Americas Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free recall — FDA D-0103-2021
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Class IFDA: CompletedSunstar Americas, Inc.
DrugNov 25, 2020
Albek De Mexico S.A. De C.V Assured Instant Hand Sanitizer Aloe & Moisturizers recall — FDA D-0080-2021
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were…
Class IIFDA: OngoingAlbek De Mexico S.A. De C.V.
DrugNov 25, 2020
Grato Holdings Homeopathic Energy Catalyst, 1 fl oz (30 mL) recall — FDA D-0099-2021
Labeling: Product Contains Undeclared API; Incorrect formulation
Class IIIFDA: TerminatedGrato Holdings, Inc.
DrugNov 25, 2020
Apotex Aripiprazole Tablets, USP 15 mg tablets recall — FDA D-0106-2021
Failed Dissolution Specifications: Out of specification for dissolution.
Class IIFDA: TerminatedApotex Corp.
DrugNov 25, 2020
Milbar Laboratories DCL T Shampoo for Hair and Body recall — FDA D-0087-2021
GMP Deviations
Class IIFDA: TerminatedMilbar Laboratories, Inc.
DrugNov 25, 2020
Preferred Pharmaceuticals Metformin HCl Extended Release Tablets USP 500 mg, Generic for recall — FDA D-0077-2021
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class IIFDA: TerminatedPreferred Pharmaceuticals, Inc.
DrugNov 25, 2020
Albek De Mexico S.A. De C.V Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera recall — FDA D-0079-2021
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were…
Class IIFDA: OngoingAlbek De Mexico S.A. De C.V.
How to use this drug recall index
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.