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Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited Recalls

All product recalls associated with Alembic Pharmaceuticals Limited.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 66 recalls

Fesoterodine Tablets (Alembic) – Impurity Levels (2025)

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

Class IIILow

FDAOct 10, 2025Nationwide• Alembic Pharmaceuticals Limited

Doxepin Hydrochloride Capsules (Alembic) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAJul 25, 2025Nationwide• Alembic Pharmaceuticals Limited

E-Bike Lithium Batteries (VIVI) – Fire Hazard (2025)

Fire/Burn Risk

This recall involves 36-volt lithium-ion rechargeable batteries included with certain "VIVI" brand e-bikes. E-bike model information can be found on a consumer's sales order documentation and on certain bicycle frames. Battery model information is located on the battery itself. "VIVI is printed on the bicycle downtube. The following e-bike model numbers and battery model numbers are included in this recall: Affected E-Bike Model Number Recalled Battery Model Number C26 WT0261, 36V-8AH-288WH, ZBL-36V8AH ZK, SKD015, EB3608C0B MT20 WT0261, SKD014, ZBL-36V10.4Ah LH Z3 TCRFD111005YY M026SH 36V-8Ah-288Wh, ZBL-36V8Ah288Wh, ZBL-36V8Ah288Wh ZK, EB360817E, SKD036008016A H6 EB3610D0B, ZBL-36V10Ah, SKD011, 36V-10.4AH-374.4Wh, SKD036010003A H7 EB3610C5B, 36V-10.4AH-374.4Wh MT26H ZBL-36V8Ah ZK 26LGB EB360808L, 36V-8AH-300WH, 36V-8AH-288WH, WT0260, SKD036008009A, ZBL-36V8AH, ZBL-36V8AH ZK, ZBL10SP36V8AH M026TGB EB360808L, 36V-8AH-300WH, 36V-8AH-288WH, WT0260, SKD036008009A, ZBL-36V8AH, ZBL-36V8AH ZK, ZBL10SP36V8AH MT26G EB360808L, 36V-8AH-300WH, 36V-8AH-288WH, WT0260, SKD036008009A, ZBL-36V8AH, ZBL-36V8AH ZK, ZBL10SP36V8AH FM20 WT0289, EB3608B2S, 36V-8AH-288WH F20 36V-8AH-288WH, EB3608B4S S3 TCRFD021004006, TCRFD031004006, TTTT07F01, TCRFD181004JB, TCRFD011004JB, TC-TT011005B Z1 TT09F01 Z2 TT09F01

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CPSCJul 17, 2025Nationwide• Guangzhou Plenty Bicycle Co., Ltd., of China

Kiwi Electronic Recliner (Babyletto) – Overheating Risk (2025)

This recall involves Babyletto Kiwi Electronic Recliner and Glider fabric-covered chairs with two USB device charging ports. The chair is covered in various color fabrics and is approximately 29 inches wide by 36 inches deep and 41 inches high and weighs approximately 125 pounds. Units included in the recall include the following production colors, SKUs, and batch numbers. Batch numbers are printed on a white label found underneath the footrest. Color SKU Batch Number Located Under the Footrest Almond Teddy Loop with Light Wood Base M11288ATLB WC0234712405 WC0238412406 WC0238412407 WC0241142406 Latte Teddy Loop with Dark Wood Base M11288LTDB WC0229042401 WC0229052405 WC0234712405 Olive Boucle with Light Wood Base M11288OBLB WC0220062307 WC0220082308 WC0229042401 WC0229052401 WC0234712405 WC0238412407 Performance Beach Eco-Weave M11288PBEW WC0220082308 WC0223842309 WC0223842310 WC0229042401 WC0229052401 WC0229422402 WC0234712405 Performance Cream Eco-Weave M11288PCMEW WC0223842309 WC0227982312 WC0229042401 WC0229042405 WC0229052405 WC0229422405 WC0234552406 Performance Frost Eco-Twill with Light Wood Base M11288PFETLB WC0239882407 Performance Grey Eco-Weave M11288PGEW WC0220082308 WC0223842310 WC0227982312 WC0229042404 WC0229422404 WC0239122407 Performance Natural Eco-Twill with Light Wood Base M11288PNETLB WC0215282305 WC0239882407 WC0223832309 WC0229042401 Ivory Boucle with Gold Base M11288WBG WC0220062307 WC0223832309 WC0223842309 WC0223842310 WC0227982312 WC0229052401 WC0229422402 WC0229422404 WC0234712405 WC0238412406 WC0238412407

CPSCJul 17, 2025Nationwide• Guangzhou Plenty Bicycle Co., Ltd., of China

Celecoxib Capsules (Alembic) – Foreign Tablet Contamination (2025)

Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

Class IIModerate

FDAMay 9, 2025Nationwide• Alembic Pharmaceuticals Limited

Bromfenac Ophthalmic Solution (Alembic) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAMay 7, 2025Nationwide• Alembic Pharmaceuticals Limited

AcetaZOLAMIDE Tablets (Rubicon) – Discoloration (2024)

Discoloration

Class IIILow

FDAAug 24, 2024Nationwide• Rubicon Research Private Limited

Metoprolol Tablets (Rubicon) – Metal Contamination (2024)

Presence of Foreign Substance: metal in tablet

Class IIModerate

FDAMay 6, 2024Nationwide• Rubicon Research Private Limited

Tramadol Tablets (Rubicon) – Foreign Tablet Presence (2024)

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

Class IIModerate

FDAApr 26, 2024Nationwide• Rubicon Research Private Limited

Butter Flavored Popcorn (Bickel's) – Undeclared milk (2023)

Undeclared Milk

Undeclared milk

Class IIModerate

FDAAug 8, 2023Nationwide• Bickel's Snack Foods Inc

Tobramycin Ophthalmic Solution (Alembic) – Impurity Specifications (2023)

Failed Impurities/Degradation Specifications

Class IIILow

FDAJul 27, 2023Nationwide• ALEMBIC PHARMACEUTICALS, INC.

Diclofenac Sodium Topical Solution (Alembic) – Delivery System Defect (2023)

Defective Delivery System

Class IIModerate

FDAJun 22, 2023Nationwide• ALEMBIC PHARMACEUTICALS, INC.

Electric Bicycles (Linus Bike) – Crash hazard (2023)

This recall involves the Linus Bike Cesta 500 and Ero 500 electric bicycles. The serial number can be found on the underside of the frame near the chain ring. The brand name "Linus" is printed on the frame of the bicycle. The recalled bicycles have one of the following serial numbers. Product Name Serial Number Ero500/Cesta500 LXD20100231-LXD20100420 Ero500/Cesta500 LXD20100686- LXD20100830 Ero500/Cesta500 LXD20100956- LXD20101060

CPSCFeb 16, 2023Nationwide• Shenzhen Xidesheng Bicycle Co Ltd, of China

Heckler 9 E-Bike (Santa Cruz) – Fall Fire Risk (2022)

Fire/Burn Risk

This recall involves 2022 Santa Cruz Heckler 9 model electric bicycles (e-bikes), which were sold in Gloss Avocado Green or Maritime Gray colors. They come with an interchangeable 720WH battery that sits inside a black case under the frame. The name "SANTA CRUZ" is printed on the sides of the downtube of the bicycle frame, and "Heckler" is printed on the top tube of the frame and on the inside of the left chainstay on the frame.

CPSCMay 5, 2022Nationwide• Santa Cruz Bicycles LLC, of Santa Cruz, California

Metoprolol Tablets (Rubicon Research) – Metal Embedded (2021)

Complaint received of foreign matter (metal) embedded in tablet.

Class IIModerate

FDADec 31, 2021Nationwide• Rubicon Research Private Limited

Telmisartan Tablets (Alembic) – Label Mixup (2021)

Labeling: Label-mixup

Class IHigh

FDAMar 17, 2021Nationwide• Alembic Pharmaceuticals Limited

Butter Flavored Popcorn (Bickel's) – Undeclared Milk (2021)

Undeclared Milk

Undeclared milk due to mislabeling

Class IIModerate

FDAJan 22, 2021AL, CO, FL +7 more• Bickel's Snack Foods Inc

Instinct Bicycle (Rocky Mountain) – Frame Safety (2020)

This recall includes the alloy models of Rocky Mountain model year 2018-2020 Instinct, Instinct BC and Pipeline trail bikes. Rocky Mountain is printed on the downtube. Instinct, Instinct BC or Pipeline are printed inside the seatstay on the left hand side. The bikes were sold with 29 inch and 27.5+ inch wheels. The recalled bikes include small, medium and large sizes with serial numbers starting with PRK17, PRK18 and PRK19-XXXXX. The serial number is located under the bottom frame bracket. Only non-electric bicycles with alloy frames in all colors in these models with these serial numbers are affected. Recalled Rocky Mountain Bicycles PIPELINE ALLOY 50 Pipeline Alloy 50 SM Pipeline Alloy 50 MD Pipeline Alloy 50 LG PIPELINE ALLOY 30 Pipeline Alloy 30 SM Pipeline Alloy 30 MD Pipeline Alloy 30 LG INSTINCT ALLOY 70 Instinct Alloy 70 SM C1 Instinct Alloy 70 SM C2 Instinct Alloy 70 MD C1 Instinct Alloy 70 MD C2 Instinct Alloy 70 LG C1 Instinct Alloy 70 LG C2 INSTINCT ALLOY 50 Instinct Alloy 50 (29) SM C1 Instinct Alloy 50 (29) SM C2 Instinct Alloy 50 (29) MD C1 Instinct Alloy 50 (29) MD C2 Instinct Alloy 50 (29) LG C1 Instinct Alloy 50 (29) LG C2 INSTINCT ALLOY 30 Instinct Alloy 30 (29) SM C1 Instinct Alloy 30 (29) SM C2 Instinct Alloy 30 (29) MD C1 Instinct Alloy 30 (29) MD C2 Instinct Alloy 30 (29) LG C1 Instinct Alloy 30 (29) LG C2 INSTINCT ALLOY 70 BC EDITION Instinct Alloy 70 BC Edition SM Instinct Alloy 70 BC Edition MD Instinct Alloy 70 BC Edition LG INSTINCT ALLOY 50 BC EDITION Instinct Alloy 50 BC Edition SM C1 Instinct Alloy 50 BC Edition SM C2 Instinct Alloy 50 BC Edition MD C1 Instinct Alloy 50 BC Edition MD C2 Instinct Alloy 50 BC Edition LG C1 Instinct Alloy 50 BC Edition LG C2 Affected Serial Numbers All serial numbers beginning with PRK17 All serial numbers beginning with PRK18 The following serial numbers beginning with PRK19 PRK190001 to PRK1900454 PRK1900566 PRK1900723 to PRK1900731 PRK1900456 to PRK1900462 PRK1900568 to PRK1900582 PRK1900733 PRK1900466 to PRK1900474 PRK1900584 to PRK1900589 PRK1900735 to PRK1900755 PRK1900479 PRK1900592 to PRK1900593 PRK1900757 to PRK1900773 PRK1900481 to PRK1900483 PRK1900595 PRK1900776 to PRK1900778 PRK1900485 to PRK1900488 PRK1900597 to PRK1900606 PRK1900780 to PRK1900785 PRK1900490 to PRK1900495 PRK1900608 to PRK1900618 PRK1900787 to PRK1900792 PRK1900497 to PRK1900506 PRK1900620 to PRK1900621 PRK1900794 to PRK1900798 PRK1900508 to PRK1900512 PRK1900623 to PRK1900628 PRK1900800 to PRK1900807 PRK1900514 to PRK1900517 PRK1900630 to PRK1900653 PRK1900809 PRK1900519 to PRK1900520 PRK1900655 to PRK1900662 PRK1900811 to PRK1900812 PRK1900522 to PRK1900523 PRK1900664 to PRK1900668 PRK1900814 to PRK1900818 PRK1900525 to PRK1900527 PRK1900670 to PRK1900681 PRK1900820 to PRK1900830 PRK1900529 to PRK1900531 PRK1900683 to PRK1900684 PRK1900832 PRK1900533 to PRK1900536 PRK1900686 to PRK1900697 PRK1900836 to PRK1900843 PRK1900538 to PRK1900540 PRK1900699 PRK1900845 to PRK1900855 PRK1900542 to PRK1900543 PRK1900701 PRK1900857 to PRK1900859 PRK1900545 to PRK1900546 PRK1900703 PRK1900861 PRK1900548 to PRK1900550 PRK1900705 PRK1900863 to PRK1900868 PRK1900552 to PRK1900556 PRK1900707 to PRK1900711 PRK1900870 PRK1900558 to PRK1900559 PRK1900713 to PRK1900721 PRK1900872- PRK1900874 PRK1900562 to PRK1900563

CPSCJul 16, 2020Nationwide• Rocky Mountain Bicycles, of Canada

Aripiprazole Tablets (Alembic Pharmaceuticals) – Labeling Mixup (2020)

Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.

Class IIModerate

FDAJun 10, 2020Nationwide• Alembic Pharmaceuticals Limited

Abbott Mountain Bicycle (Schwinn) – Fall Hazard (2018)

This recall involves Schwinn Abbott Adult Men's Full Suspension Mountain Bicycles. The bicycles are black with green, yellow and blue accent colors on the downtubes. The bicycles were sold with 29 inch tires. "Schwinn" is printed in green and yellow on the downtube of the bicycle and "Abbott" is printed in blue on the top tube of the bicycle near the bicycle stem and handlebars.

CPSCOct 25, 2018Nationwide• Tianjin Fuji-ta Bicycle Industrial Co. Ltd., of China