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Bayer Healthcare Pharmaceuticals Inc.
Bayer Healthcare Pharmaceuticals Inc.: 30 FDA recall reports
Every drug recall the FDA has published for Bayer Healthcare Pharmaceuticals Inc.. The fault, and how the agency graded it.
30Reports
10Class I
0Ongoing
2023-12-06Most recent
10 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Class I
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pha
D-0145-2024 · Class I · reported 2023-12-06 · Terminated
- Why it was recalled
- Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
- Product
- VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
- Where it went
- Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
- How much
- 192 bottles
Class I
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (
D-0253-2022 · Class I · reported 2021-11-24 · Terminated
- Why it was recalled
- Chemical Contamination: presence of benzene
- Product
- Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 2,841,012 cans
Class I
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b
D-0251-2022 · Class I · reported 2021-11-24 · Terminated
- Why it was recalled
- Chemical Contamination: presence of benzene
- Product
- Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 4,990,860 cans
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4,
D-0242-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 738,432 cans
Class I
LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Health
D-0247-2022 · Class I · reported 2021-11-24 · Terminated
- Why it was recalled
- Chemical Contamination: presence of benzene
- Product
- LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 4,546,152 cans
LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare
D-0236-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 2,817,468 cans
Class I
Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer
D-0249-2022 · Class I · reported 2021-11-24 · Terminated
- Why it was recalled
- Chemical Contamination: presence of benzene
- Product
- Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0010-2.
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 579,456 cans
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer H
D-0239-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1.
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 77,076 cans
Class I
LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcar
D-0246-2022 · Class I · reported 2021-11-24 · Terminated
- Why it was recalled
- Chemical Contamination: presence of benzene
- Product
- LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 2,817,468 cans
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a)
D-0240-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland,
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 579,456 cans
Class I
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whipp
D-0250-2022 · Class I · reported 2021-11-24 · Terminated
- Why it was recalled
- Chemical Contamination: presence of benzene
- Product
- Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 738,432 cans
LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare
D-0237-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 4,546,152 cans
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 587
D-0254-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 579,456 units
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b)
D-0243-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 4,990,860 cans
Class I
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippa
D-0252-2022 · Class I · reported 2021-11-24 · Terminated
- Why it was recalled
- Chemical Contamination: presence of benzene
- Product
- Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 592,416 cans
LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 1
D-0238-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 3,816,468 cans
Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0
D-0241-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 1,801,332 cans
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (
D-0245-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 2,841,012 cans
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippa
D-0244-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 592,416 cans
Class I
LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, W
D-0248-2022 · Class I · reported 2021-11-24 · Terminated
- Why it was recalled
- Chemical Contamination: presence of benzene
- Product
- LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 3,816,468 cans
Class I
All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individ
D-0697-2018 · Class I · reported 2018-05-02 · Terminated
- Why it was recalled
- Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.
- Product
- All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.
- Where it went
- Nationwide in the USA
- How much
- 188,631 units
Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%)
D-0590-2018 · Class II · reported 2018-03-14 · Terminated
- Why it was recalled
- Labeling: Label mix-up
- Product
- Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.
- Where it went
- Arkansas only
- How much
- 528 units
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthc
D-0135-2018 · Class III · reported 2018-01-03 · Terminated
- Why it was recalled
- Failed Stability Specifications
- Product
- Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577
- Where it went
- Natonwide
- How much
- 104,128 HDPE bottles
Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydro
D-1044-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
- Product
- Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194
- Where it went
- Nationwide
- How much
- 1,067,520 12-count cartons
Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodiu
D-1051-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
- Product
- Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500041085
- Where it went
- Nationwide
- How much
- 56,064 36-count cartons
Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anh
D-1050-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
- Product
- Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048
- Where it went
- Nationwide
- How much
- 24,672 24-count cartons
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288
D-0604-2017 · Class III · reported 2017-03-29 · Terminated
- Why it was recalled
- Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
- Product
- A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981
- Where it went
- US Nationwid, Puerto Rico, and Iceland
- How much
- a) 468,576 (1.5g); b) 203868 (3 oz) and c) 802,620 (4 oz)
Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 k
D-807-2013 · Class III · reported 2013-07-24 · Terminated
- Why it was recalled
- Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
- Product
- Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin
- Where it went
- NY, CA
- How much
- 194.62 kg
Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmace
D-156-2013 · Class III · reported 2013-02-13 · Terminated
- Why it was recalled
- Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
- Product
- Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2
- Where it went
- Nationwide
- How much
- 138,505 vials
Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 16
D-1433-2012 · Class II · reported 2012-08-08 · Terminated
- Why it was recalled
- Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
- Product
- Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.
- Where it went
- Kansas and California.
- How much
- 112.295 kg
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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