Browse Drug Recalls

534 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 534 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 534 FDA drug recalls in 2012.

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Date	Product	Reason	Class	Firm
May 25, 2012	HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHE...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/H...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1G...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML; FORMIX 100MCG / 3...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML (1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML; AMIKACIN SULFATE**** 4ML SDV 2...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LI...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 M...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 M...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAI...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACI...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BACTERIOSTATIC SODIUM CHLORIDE 10ML VIAL** 0.9% INJECTABLE 10 ML, 10 MLS, 100...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	ACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYD...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML; FORSKOL...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	COPPER GLUCONATE 2MG/ML INJECTABLE 30 ML, 60 ML (2 DIFFERENT PRODUCTS)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/0.1ML INJECTABLE ...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHIN...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHE...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPI...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	CYCLOPENT/KETOROLAC/PHENYLEPH/TROPICAMIDE 1%/0.5%/2.5%/1% OPHTHALMIC 70 ML (1...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 V...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BUPIVACAINE/CLONIDINE/MORPHINE/ZICONOTIDE, P.F. 20MG/400MCG/20MG/1.5MCG/ML IN...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	CYCLOPENTALATE/PHENYLEPHRINE 1%/2.5% OPHTHALMIC 5 ML (1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 M...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200M...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 K...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	CYCLOPENT/FLURBIPR/PHENYLEPH/PROPARACAINE .25%/0.0075%/0.625%/0.125% OPHTHALM...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL; BUP...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 DIFFERENT PRODUCTS)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIA...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML (1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS,...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML; HYDROMORPHONE P.F. 25MG/ML INTR...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML; FENTANYL, P.F...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE 10 ML, 12 ML, 13 ML, 15 ML, ...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML (1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECT...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE ...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHON...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML (6 DIFFEREN...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM; ACYCLOVIR OPHTHALMIC 3% SOLUTION 5 ML ...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HYDROXOCOBALAMIN**(VIT B-12) 1000MCG/ML INJECTABLE 30 ML Injectable (4 DIFFER...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 DIFFERENT PRODUCTS)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.