2012 Product Recalls (4,173)

2012 Recall Year Insight

Federal agencies issued 4,173 product recalls indexed by PlainRecalls in calendar year 2012. That represents about 4.00% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 11.4 recalls per day across the FDA, CPSC, USDA FSIS, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 84 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2012.

On this page of 50 records, severity classification shows 0 critical, 49 moderate, and 1 lower-severity recalls. The page references 2 distinct recalling firms operating in 2 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Drug (50), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2012 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

2012 Recall Year Insight

BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML (1 PRODUCT)

HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML, 630 ML; HYALURONIDASE/LIDOCAINE/EPI/BUPIVICAINE INJECTABLE 32 ML, 64 ML (5 DIFFERENT PRODUCTS)

SESAME OPHTHALMIC OIL 60 ML (1 PRODUCT)

MEYERS COCKTAIL INJECTABLE 30 ML; MEYERS COCKTAIL (DR. MORENO) INJECTABLE 90 ML; MEYERS COCKTAIL/ CALCIUM/VIT B1/ METHYLCOBALAMIN 1GM/5MG/1000MCG/500ML INJECTAB 250 ML 5 ML (4 DIFFERENT PRODUCTS)

KENALOG-40** (MDV 10ML VIAL) 40MG/ML INJECTABLE 50 ML (1 PRODUCT)

FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML; FORMIX 100MCG / 30MG / 2MG INJECTABLE 10 ML (4 DIFFERENT PRODUCTS)

TROPICAMIDE OPHTHALMIC P.F. 1% SOLUTION 30 ML (1 PRODUCT)

SELENIUM 200MCG/ML INJECTABLE 150 ML 30 ML 60 ML (3 DIFFERENT PRODUCTS)

CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM INJECTABLE 10 VIAL (2 DIFFERENT PRODUCTS)

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04

AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT)

HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1500MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% SODIUM CHLORIDE) 50MG/500MCG/7.5MG/ML I 18 ML (3 DIFFEENT PRODUCTS)

EDETATE DISODIUM PF IN BSS 3% OPHTHALMIC 10 ML; EDETATE DISODIUM SOLUTION IN ARTIFICIAL TEARS 0.05% OPHTHALMIC 10 ML (2 DIFFERENT PRODUCTS)

KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; KETOROLAC TROMETHAMINE 60MG/ML INJECTABLE 48 ML; KETOROLAC TROMETHAMINE, 1ML SDV**25X1ML 30MG/ML INJECTABLE 50 ML 75 ML; KETOROLAC TROMETHAMINE, P.F. 60MG/ML INJECTABLE 10 ML (7 DIFFERENT PRODUCTS)

NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML 5 ML 6 ML;

LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE 100 ML 80 ML (2 DIFFERENT PRODUCTS)

GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS)

MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL 10 VIAL 15 VIAL 2 VIAL 20 VIAL

TROPICAMIDE/PHENYLEPHRINE OPHTHALMIC 15:1 SOLUTION 128 ML 480 ML 496 ML 576 ML 90 ML (5 DIFFERENT PRODUCTS)

ETOMIDATE 0.2% (2MG/ML) INJECTABLE 20 ML (1 PRODUCT)

DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML, 20 ML, 300 ML; DIAZEPAM 2.5MG/ML INJECTABLE 40 ML; DIAZEPAM 2MG/ML INJECTABLE 100 ML, 50 ML (8 DIFFERENT PRODUCTS)

GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT)

ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML, 20 ML, 40 ML, 5 ML, 60 ML; ETHYL ALCOHOL 20% INJECTABLE 5 ML; ETHYL ALCOHOL 5% INJECTABLE 180 ML, 30 ML; ETHYL ALCOHOL 95% INJECTABLE 10 ML, 8 ML; ETHYL ALCOHOL OPHTHALMIC 40% INJECTABLE 50 ML (13 DIFFERENT PRODUCTS)

PILOCARPINE HCL P.F IN B.S.S OPHTHALMIC 1% INJECTABLE 36 ML; PILOCARPINE HCL SOLUTION 0.5% OPHTHALMIC 30 ML; PILOCARPINE HCL SOLUTION (PF) 0.5% OPHTHALMIC 30 ML (3 DIFFERENT PRODUCTS)

CLINDAMYCIN OPHTHALMIC (PF) 20MG/ML (2MG/0.1ML) SOLUTION 2 ML; CLINDAMYCIN PHOSPHATE OPHTHALMIC, INTRAVITREAL (P.F.) 1MG/0.1ML INJECTABLE 0.2 ML; CLINDAMYCIN PHOSPHATE SDPF- (0.1ML SYRINGE,30G,1/2") 1MG/0.1ML INJECTABLE 0.1 ML (3 DIFFERENT PRODUCTS)

PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML; PHENYLEPHRINE HCL, 1ML VIAL*** 1% (10MG/ML) INJECTABLE 1 ML 10 ML 25 ML 5 ML 50 ML; PHENYLEPHRINE, STSL, P.F. (0.5ML SYRINGE, SLIP-TIP, NO NEEDLE) 1.25% INJECTABLE 5 ML 7.5 ML (8 DIFFERENT PRODUCTS)

DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100 ML, 108 ML, 120 MLS, 25 ML, 32 ML, 60 ML, 90 ML, 90 MLS; DIPHENHYDRAMINE, SDV, 25X1ML** 50MG/ML INJECTABLE 25 ML (11 DIFFERENT PRODUCTS)

POTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORIDE IN NORMAL SALINE 40MEQ/100ML (400MEQ/L) INJECTABLE 1000 ML; POTASSIUM CHLORIDE**(25X20ML) 2MEQ/ML INJECTABLE 500 ML; POTASSIUM PHOSPHATE 4.4MEQ/ML (3MMOL/ML) INJECTABLE 300 ML 750 ML (5 DIFFERENT PRODUCTS)

HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML (1 PRODUCT)

LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ML 240 ML 300 ML 400 ML (7 DIFFERENT PRODUCTS)

PREDNISOLONE ACETATE 10MG/ML INJECTABLE 10 MLS (1 PRODUCT)

THIOTEPA, LYOPHILIZED 15MG INJECTABLE 8 VIAL; THIOTEPA, LYOPHILIZED 30MG INJECTABLE 4 VIAL 8 VIAL; THIOTEPA, LYOPHILIZED 60MG INJECTABLE 2 VIAL (4 DIFFERENT PRODUCTS)

PACLITAXEL 6MG/ML INJECTABLE 500 ML (1 PRODUCT)

DAPIPRAZOLE OPHTHALMIC 0.5% SOLUTION 10 ML; DAPIPRAZOLE, LYOPHILIZED, OPHTHALMIC KIT 0.5% POWDER 1 KIT, 10 KIT, 2 KIT, 3 KIT, 4 KIT, 6 KIT (7 DIFFERENT PRODUCTS)

DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT)

FUROSEMIDE*** (25X10ML) 10MG/ML INJECTABLE 250 ML; FUROSEMIDE*** (25X4ML) 10MG/ML INJECTABLE 2 VIAL (2 DIFFERENT PRODUCTS)

HYPERTONIC SOLUTION IN PRESERVED WATER 10% INJECTABLE 50 ML (1 PRODUCT)

ZINC CHLORIDE 10MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)

THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 12 VIAL 12 VIALS 2 VIALS 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 6 VIAL 6 VIALS 8 VIALS (13 DIFFERENT PRODUCTS)

Nearby Recall Years

Data Sources

POTASSIUM CHLORIDE *(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORIDE IN NORMAL SALINE 40MEQ/100ML (400MEQ/L) INJECTABLE 1000 ML; POTASSIUM CHLORIDE(25X20ML) 2MEQ/ML INJECTABLE 500 ML; POTASSIUM PHOSPHATE 4.4MEQ/ML (3MMOL/ML) INJECTABLE 300 ML 750 ML (5 DIFFERENT PRODUCTS)

FUROSEMIDE* (25X10ML) 10MG/ML INJECTABLE 250 ML; FUROSEMIDE* (25X4ML) 10MG/ML INJECTABLE 2 VIAL (2 DIFFERENT PRODUCTS)