Drug Recall List Last Updated: October 2021 Drug Recall Details Contact Date Drug Recall Class* Zonisamide Voluntary: Firm initiated If you have questions September Class 61919077530 about this recall, Direct 2021 II Rx, 1-678-619-5510 Metoprolol Tartrate Voluntary: Firm initiated If you have questions September Class 06586206499 about this recall, 2021 II Aurobindo Pharma USA Inc., 1-866-850-2876 Entacapone Voluntary: Firm initiated If you have questions September Class 00904682204 about this recall, The 2021 II Harvard Drug Group, 1- 800-875-0123. Valproic Acid Voluntary: Firm initiated If you have questions September Class 06043262116 about this recall, 2021 II Morton Grove Pharmaceuticals, Inc., 1- 888-721-7115 Promethazine With Codeine Voluntary: Firm initiated If you have questions September Class 06043260616 about this recall, 2021 II Morton Grove Pharmaceuticals, Inc., 1- 888-721-7115 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences. NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information. Promethazine Syrup Voluntary: Firm initiated If you have questions September Class 06043260816 about this recall, 2021 II Morton Grove Pharmaceuticals, Inc., 1- 888-721-7115 Arformoterol Tartrate Voluntary: Firm initiated If you have questions September Class 06846283365 about this recall, 2021 II 06846283335 Glenmark Pharmaceuticals Inc, 1-888-721-7115 Zonisamide Voluntary: Firm initiated If you have questions September Class 06846212901 about this recall, 2021 II 06846213001 Glenmark 06846213005 Pharmaceuticals Inc, 1-888-721-7115 Chlorzoxazone Voluntary: Firm initiated If you have questions September Class II 06846272401 about this recall, 2021 06846272501 Glenmark Pharmaceuticals Inc, 1-888-721-7115 Naproxen Sodium Voluntary: Firm initiated If you have questions September Class II 06846217801 about this recall, 2021 06846217901 Glenmark 06846217905 Pharmaceuticals Inc, 1-888-721-7115 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences. NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information. Fulvestrant Voluntary: Firm initiated If you have questions September Class II 06846231732 about this recall, 2021 Glenmark Pharmaceuticals Inc, 1-888-721-7115 Carbamazepine Voluntary: Firm initiated If you have questions September Class 00904617261 about this recall, The 2021 II Harvard Drug Group, 1- 800-875-0123. Betadine Solution Swabstick Voluntary: Firm initiated If you have questions September Class 06761815301 about this recall, 2021 II 06761815303 AVRIO HEALTH L.P, 1- 888-726-7535 Chantix (varenicline) Voluntary: Firm initiated If you have questions September Class 00069047103 about this recall, Pfizer 2021 II 00069046856 Inc.,1-800-438-1985. 00069046956 00069046903 Oxycodone Hydrochloride Presence of Foreign If you have questions September Class 04285800201 Tablets/Capsules; A single foreign about this recall, Akorn, 2021 II tablet Hydrochlorothiazide/Lisinopril Inc, Rhodes 25/20 was found in one bottle Pharmaceuticals, L.P., 1-401-262-9400, Prompt 2 Betamethasone Dipropionate Failed impurities/degradation If you have questions September Class 06174848030 specification: Out of Specification for about this recall, Akorn, 2021 II an unknown impurity observed in Inc, 1-800-932-5676, topical product. Prompt 2 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences. NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information. Naproxen Sodium Voluntary: Firm initiated If you have questions September II 06220776236 about this recall, 2021 Granules USA, Inc., 1877-770-3183 Clopidogrel Voluntary: Firm initiated If you have questions September II 03334206015 about this recall, 2021 Macleods Pharma Usa Inc, 1-888-943-3210 Cyclobenzaprine Hydrochloride Voluntary: Firm initiated If you have questions September II 00591333001 about this recall, 2021 07019901401 Teva Pharmaceuticals 05723726601 USA, 1-800-545-8800 FLUDARABINE PHOSPHATE Lack of Assurance of Sterility: the If you have questions September II FOR INJECTION manufacturing firm had microbial about this recall, 2021 02420123701 recoveries during environmental Custopharm, Inc., 1760- monitoring in aseptic areas of 683-0901 manufacturing. Erythromycin Topical Solution Defective container: possibility for If you have questions September II 05256502759 lack of seal integrity. about this recall, Teligent 2021 Pharma, 1-856-697-1441 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences. NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information. Atovaquone Oral Suspension Temperature abuse: the firm received If you have questions September II 01070222321 customer complaints of unusual about this recall, 2020 grittiness in the product. KVK-Tech, Inc., 1-215- 579-1842 Carvedilol Presence of Foreign If you have questions September II 06838209505 Tablets/Capsules; report of two about this recall, 2021 70518182601 Paroxetine tablets were found in the RemedyRepack Inc., 1- bottle 866-845-3791 Adenosine Lack of Assurance of Sterility If you have questions August II 01671418001 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Leucovorin Calcium Lack of Assurance of Sterility If you have questions August II 00703514001 about this recall, 2021 00703514591 Teva Pharmaceuticals USA, 1-800-545-8800 Octreotide Acetate Lack of Assurance of Sterility If you have questions August II 00703331101 about this recall, 2021 00703330101 Teva Pharmaceuticals USA, 1-800-545-8800 Methylprednisolone Acetate Lack of Assurance of Sterility If you have questions August II 00703005101 about this recall, 2021 00703006301 Teva Pharmaceuticals USA, 1-800-545-8800 Alprostadil Lack of Assurance of Sterility If you have questions August II 00703150101 about this recall, 2021 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences. NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information. Teva Pharmaceuticals USA, 1-800-545-8800 Metoclopramide Lack of Assurance of Sterility If you have questions August II 00703450201 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Adenosine Injection Lack of Assurance of Sterility If you have questions August II 00703877601 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Norepinephrine Bitartrate Lack of Assurance of Sterility If you have questions August II 00703115301 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Epoprostenol Sodium Lack of Assurance of Sterility If you have questions August II 00703199501 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Leucovorin Calcium Lack of Assurance of Sterility If you have questions August II 00703514501 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 Octreotide Acetate Lack of Assurance of Sterility If you have questions August II 00703333301 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800 * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. Class 3 Recall: Using the drug is not likely to cause adverse health consequences. NOTE: This is not a complete list of all recalls. Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information. Vecuronium Bromide Lack of Assurance of Sterility If you have questions August II 00703291401 about this recall, 2021 Teva Pharmaceuticals USA, 1-800-545-8800