Whippany, NJ, United States
Bayer Healthcare Pharmaceuticals Inc. recalls
5 recalls recorded since 2018, most recently on 6 November 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)3
Terminated Class I Drugs
- Recall started
- 6 November 2023
- Terminated
- 29 May 2024
- Reason
- Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
- Distribution
- Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0145-2024
- VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Terminated Class I, Class II Drugs
- Recall started
- 1 October 2021
- Terminated
- 26 June 2023
- Reason
- Chemical Contamination: presence of benzene
- Distribution
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0253-2022, D-0251-2022, D-0242-2022, D-0247-2022, D-0236-2022, D-0249-2022, D-0239-2022, D-0246-2022, D-0240-2022, D-0250-2022, D-0237-2022, D-0254-2022 and 7 more
- 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 11
- 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 11
- 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
- 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
- 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
- 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.
- 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.
- 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
- and 11 more product lines
Terminated Class I Drugs
- Recall started
- 15 March 2018
- Terminated
- 14 January 2020
- Reason
- 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.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0697-2018
- 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 corne
Terminated Class II Drugs
- Recall started
- 23 February 2018
- Terminated
- 9 January 2020
- Reason
- Labeling: Label mix-up
- Distribution
- Arkansas only
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0590-2018
- 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.
Terminated Class III Drugs
- Recall started
- 10 November 2017
- Terminated
- 3 April 2020
- Reason
- Failed Stability Specifications
- Distribution
- Natonwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0135-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.